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Inotuzumab Ozogamicin and Blinatumomab in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia

Primary Purpose

B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, Recurrent B Acute Lymphoblastic Leukemia, Refractory B Acute Lymphoblastic Leukemia

Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Blinatumomab
Inotuzumab Ozogamicin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pre-registration Eligibility Criteria (Step 0)

  • Submission of bone marrow aspirate and peripheral blood for MRD analysis is mandatory prior to registration; the bone marrow sample should be from the first aspiration (i.e. first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be initiated as soon as possible after pre-registration. The specimens should be sent to the HEME Biobank.

    • Lumbar Puncture (Spinal Tap) and Intrathecal Methotrexate:

      • Patients may receive the day 1 of course IA dose of intrathecal (IT) methotrexate during the prior-to-registration lumbar puncture (or the venous line placement) to avoid a second lumbar puncture. If the dose is administered prior to registration, then systemic chemotherapy must begin within 7 days of this IT chemotherapy.
  • Registration Eligibility Criteria (Step 1)
  • Morphologic diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL) based on World Health Organization (WHO) criteria. Patients with Burkitt lymphoma/leukemia are not eligible.
  • CD22-positive disease defined as CD22 expression by >= 20% of lymphoblasts by local hematopathology evaluation.
  • Philadelphia chromosome/BCR-ABL1-negative ALL by cytogenetics, fluorescence in situ hybridization (FISH), and/or polymerase chain reaction (PCR). If any test is positive for Philadelphia chromosome/BCR-ABL1, then the patient is ineligible.

  • No active central nervous system (CNS) leukemia (i.e. only CNS-1 disease allowed). Active CNS leukemia is defined as morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS-directed local treatment for active disease within 28 days prior to registration, symptomatic CNS leukemia (i.e. cranial nerve palsies or other significant neurological dysfunction) within the 28 days prior to registration, and/or known asymptomatic parenchymal CNS mass lesions; see below for additional guidance. Prophylactic intrathecal medication alone is not an exclusion.

    • Categories of CNS Involvement for CNS Evaluation Prior to Registration:

      • CNS 1: CSF has < 5 WBC/uL with cytospin negative for blasts; or >= 10 red blood cell (RBC)/uL with cytospin negative for blasts.
      • CNS 2: CSF has < 5 WBC/uL with cytospin positive for blasts; or >= 10 RBC/uL with cytospin positive for blasts; or >= 10 RBC/uL, WBC/uL >= 5 but less than Steinherz/Bleyer algorithm with cytospin positive for blasts (see below).

      • CNS 3: CSF has >= 5 WBC/uL with cytospin positive for blasts; or >= 10 RBC/uL, >= 5 WBC/uL and positive by Steinherz/Bleyer algorithm (see below); or clinical signs of CNS leukemia (such as facial nerve palsy, brain/eye involvement or hypothalamic syndrome). Steinherz/Bleyer Method of Evaluating Initial Traumatic Lumbar Punctures:

        • If the patient has leukemia cells in the peripheral blood and the lumbar puncture is traumatic and contains >= 5 WBC/uL with blasts, the following algorithm should be used to define CNS disease: CSF WBC/CSF RBC > 2 x (Blood WBC/Blood RBC count)

  • Patients with known or suspected testicular involvement by leukemia are allowed provided that the patient receives concomitant scrotal/testicular radiotherapy.

    • Unilateral or bilateral testicular enlargement should be assessed by ultrasound or other imaging technique. Biopsy is recommended if clinical findings are equivocal or suggestive of hydrocele or a non-leukemic mass, but further assessments are per treating physician discretion.

  • Not pregnant and not nursing.

    • This study involves agents that have known genotoxic, mutagenic, and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required.
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
  • No unstable cardiac disease such as myocardial infarction, angina pectoris, uncontrolled heart failure, or uncontrolled cardiac arrhythmia within 6 months of registration.
  • No impaired cardiac function, defined as left ventricular ejection fraction (LVEF) < 45% or New York Heart Association (NYHA) stage III or IV congestive heart failure (CHF).
  • Patients with known human immunodeficiency virus (HIV) infection are eligible if they have been on effective antiretroviral therapy with an undetectable viral load tested within 6 months of registration.

  • Patients with hepatitis B virus (HBV) are eligible only if they meet all the following:

    • On HBV-suppressive therapy.
    • No evidence of active virus.
    • No evidence of HBV-related liver damage.

  • Patients with hepatitis C virus (HCV) are eligible only if they meet all the following:

    • Successfully completed complete-eradication therapy with undetectable viral load.
    • No evidence of HCV-related liver damage.
  • No history of clinically relevant neurologic disorder such as epilepsy, seizure, aphasia, stroke, severe brain injury, structural brain abnormality, benign brain tumor, dementia, Parkinson's disease, movement disorder, cerebellar disease, or other significant CNS abnormalities.
  • No prior additional malignancy (i.e. in addition to ALL) except adequately treated basal- or squamous-cell skin cancer, in situ cervical cancer, stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for >= 2 years.
  • No history of clinically significant ventricular arrhythmia, unexplained non-vasovagal syncope, or chronic bradycardic states such as sinoatrial block or higher degree of atrioventricular block unless a permanent pacemaker has been implanted.
  • No history of chronic liver disease, including cirrhosis.
  • No history of sinusoidal occlusion syndrome/veno-occlusive disease of the liver.
  • No uncontrolled infection or recent history (within 4 months prior to registration) of deep tissue infections such as fasciitis or osteomyelitis.

  • Total bilirubin, serum =< 1.5 x upper limit of normal (ULN)*

    • Except in the event of: 1) Gilbert disease, in which case total bilirubin must be =< 2 x ULN, or 2) elevated bilirubin believed by investigator to be due to leukemic infiltration, in which case total bilirubin must be =< 2 x ULN.
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN
  • Creatinine, serum =< 1.5 ULN OR creatinine clearance >= 40 mL/min
  • QT interval by Fridericia's correction formula (QTcF) =< 470 msec
  • Cohort 1 Patients Only
  • Age >= 60 years.
  • No prior treatment for ALL except a single dose of intrathecal chemotherapy, corticosteroids, hydroxyurea, and/or leukapheresis to reduce peripheral blast count and prevent ALL complications. Allowed therapy may be administered for no more than 14 days and must be completed >= 24 hours prior to the initiation of protocol therapy.
  • No plan for allogeneic or autologous hematopoietic cell transplantation (HCT).
  • Cohort 2 Patients Only:
  • Age >= 18 years.
  • Relapsed or refractory disease in salvage 1 or 2.
  • No isolated extramedullary relapse.
  • Prior allogeneic HCT permitted.
  • Patients with prior allogeneic HCT must have completed transplantation >= 4 months prior to registration.
  • Patients with prior allogeneic HCT must have no evidence of graft-versus-host disease and must have completed immunosuppressive therapy >= 30 days prior to registration.
  • Prior treatment with inotuzumab ozogamicin, blinatumomab, other CD22-directed therapy, or other CD19-directed therapy is not allowed.
  • Prior treatment with rituximab must be completed >= 7 days prior to registration.
  • Prior treatment with other monoclonal antibodies must be completed >= 6 weeks prior to registration.
  • Prior treatment for ALL must be completed >= 14 days prior to registration with the following exceptions: intrathecal chemotherapy, hydroxyurea, corticosteroids, 6-mercaptopurine, methotrexate, vincristine, and/or leukapheresis to reduce circulating absolute lymphoblast count to =< 10,000/uL or prevent complications related to ALL are allowed but must be completed >= 24 hours prior to the initiation of protocol therapy.
  • Patients should have resolution of any acute non-hematologic toxicities of prior therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 grade =< 1.
  • Peripheral blood absolute lymphoblast count =< 10,000/uL (treatment allowed as above to reduce blast count to =< 10,000/uL)

Sites / Locations

  • University of Alabama at Birmingham Cancer Center
  • Anchorage Associates in Radiation Medicine
  • Anchorage Radiation Therapy Center
  • Alaska Breast Care and Surgery LLC
  • Alaska Oncology and Hematology LLC
  • Alaska Women's Cancer Care
  • Anchorage Oncology Centre
  • Katmai Oncology Group
  • Providence Alaska Medical Center
  • Kingman Regional Medical Center
  • Mercy Hospital Fort Smith
  • PCR Oncology
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
  • Community Cancer Institute
  • University Oncology Associates
  • City of Hope Comprehensive Cancer Center
  • UC San Diego Moores Cancer Center
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
  • Stanford Cancer Institute Palo Alto
  • Beebe South Coastal Health Campus
  • Beebe Medical Center
  • Delaware Clinical and Laboratory Physicians PA
  • Helen F Graham Cancer Center
  • Medical Oncology Hematology Consultants PA
  • Christiana Care Health System-Christiana Hospital
  • Beebe Health Campus
  • TidalHealth Nanticoke / Allen Cancer Center
  • Christiana Care Health System-Wilmington Hospital
  • MedStar Georgetown University Hospital
  • Holy Cross Hospital
  • Emory University Hospital/Winship Cancer Institute
  • Saint Luke's Cancer Institute - Boise
  • Saint Luke's Cancer Institute - Fruitland
  • Saint Luke's Cancer Institute - Meridian
  • Saint Luke's Cancer Institute - Nampa
  • Saint Luke's Cancer Institute - Twin Falls
  • Saint Anthony's Health
  • Illinois CancerCare-Bloomington
  • Loyola Center for Health at Burr Ridge
  • Illinois CancerCare-Canton
  • Memorial Hospital of Carbondale
  • SIH Cancer Institute
  • Illinois CancerCare-Carthage
  • Centralia Oncology Clinic
  • Northwestern University
  • University of Illinois
  • University of Chicago Comprehensive Cancer Center
  • Cancer Care Specialists of Illinois - Decatur
  • Decatur Memorial Hospital
  • Illinois CancerCare-Dixon
  • Crossroads Cancer Center
  • Illinois CancerCare-Eureka
  • Illinois CancerCare-Galesburg
  • Western Illinois Cancer Treatment Center
  • Loyola Medicine Homer Glen
  • Illinois CancerCare-Kewanee Clinic
  • Northwestern Medicine Lake Forest Hospital
  • Illinois CancerCare-Macomb
  • Loyola University Medical Center
  • Marjorie Weinberg Cancer Center at Loyola-Gottlieb
  • Good Samaritan Regional Health Center
  • UC Comprehensive Cancer Center at Silver Cross
  • Cancer Care Center of O'Fallon
  • University of Chicago Medicine-Orland Park
  • Illinois CancerCare-Ottawa Clinic
  • Illinois CancerCare-Pekin
  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
  • Illinois CancerCare-Peoria
  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
  • Methodist Medical Center of Illinois
  • OSF Saint Francis Medical Center
  • Illinois CancerCare-Peru
  • Valley Radiation Oncology
  • Illinois CancerCare-Princeton
  • Southern Illinois University School of Medicine
  • Springfield Clinic
  • Memorial Medical Center
  • Illinois CancerCare - Washington
  • Central Care Cancer Center - Garden City
  • Central Care Cancer Center - Great Bend
  • University of Kansas Cancer Center
  • University of Kansas Hospital-Westwood Cancer Center
  • Ochsner Medical Center Jefferson
  • University of Maryland/Greenebaum Cancer Center
  • Mercy Medical Center
  • Saint Joseph Mercy Hospital
  • Saint Joseph Mercy Brighton
  • Trinity Health IHA Medical Group Hematology Oncology - Brighton
  • Saint Joseph Mercy Canton
  • Trinity Health IHA Medical Group Hematology Oncology - Canton
  • Caro Cancer Center
  • Saint Joseph Mercy Chelsea
  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
  • Hematology Oncology Consultants-Clarkston
  • Newland Medical Associates-Clarkston
  • Ascension Saint John Hospital
  • Great Lakes Cancer Management Specialists-Doctors Park
  • Genesee Cancer and Blood Disease Treatment Center
  • Genesee Hematology Oncology PC
  • Genesys Hurley Cancer Institute
  • Hurley Medical Center
  • Academic Hematology Oncology Specialists
  • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
  • Michigan Breast Specialists-Grosse Pointe Woods
  • Sparrow Hospital
  • Hope Cancer Clinic
  • Trinity Health Saint Mary Mercy Livonia Hospital
  • Great Lakes Cancer Management Specialists-Macomb Medical Campus
  • Michigan Breast Specialists-Macomb Township
  • Saint Mary's Oncology/Hematology Associates of Marlette
  • 21st Century Oncology-Pontiac
  • Hope Cancer Center
  • Newland Medical Associates-Pontiac
  • Saint Joseph Mercy Oakland
  • Great Lakes Cancer Management Specialists-Rochester Hills
  • Ascension Saint Mary's Hospital
  • Oncology Hematology Associates of Saginaw Valley PC
  • Bhadresh Nayak MD PC-Sterling Heights
  • Ascension Saint Joseph Hospital
  • Advanced Breast Care Center PLLC
  • Great Lakes Cancer Management Specialists-Macomb Professional Building
  • Macomb Hematology Oncology PC
  • Michigan Breast Specialists-Warren
  • Saint John Macomb-Oakland Hospital
  • Saint Mary's Oncology/Hematology Associates of West Branch
  • Huron Gastroenterology PC
  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
  • Mayo Clinic in Rochester
  • Saint Louis Cancer and Breast Institute-Ballwin
  • Central Care Cancer Center - Bolivar
  • Cox Cancer Center Branson
  • Saint Francis Medical Center
  • Southeast Cancer Center
  • Siteman Cancer Center at West County Hospital
  • Parkland Health Center - Farmington
  • Capital Region Southwest Campus
  • Freeman Health System
  • Mercy Hospital Joplin
  • Delbert Day Cancer Institute at PCRMC
  • Mercy Clinic-Rolla-Cancer and Hematology
  • Heartland Regional Medical Center
  • Saint Louis Cancer and Breast Institute-South City
  • Washington University School of Medicine
  • Mercy Hospital South
  • Siteman Cancer Center-South County
  • Missouri Baptist Medical Center
  • Siteman Cancer Center at Christian Hospital
  • Mercy Hospital Saint Louis
  • Siteman Cancer Center at Saint Peters Hospital
  • Sainte Genevieve County Memorial Hospital
  • Mercy Hospital Springfield
  • CoxHealth South Hospital
  • Missouri Baptist Sullivan Hospital
  • Missouri Baptist Outpatient Center-Sunset Hills
  • Mercy Hospital Washington
  • Saint Patrick Hospital - Community Hospital
  • Nebraska Medicine-Village Pointe
  • University of Nebraska Medical Center
  • Carson Tahoe Regional Medical Center
  • Cancer and Blood Specialists-Henderson
  • Comprehensive Cancer Centers of Nevada - Henderson
  • Comprehensive Cancer Centers of Nevada-Horizon Ridge
  • Las Vegas Cancer Center-Henderson
  • OptumCare Cancer Care at Seven Hills
  • Comprehensive Cancer Centers of Nevada-Southeast Henderson
  • GenesisCare USA - Henderson
  • Las Vegas Urology - Green Valley
  • Las Vegas Urology - Pebble
  • Urology Specialists of Nevada - Green Valley
  • Las Vegas Urology - Pecos
  • Desert West Surgery
  • OptumCare Cancer Care at Charleston
  • University Medical Center of Southern Nevada
  • Hope Cancer Care of Nevada
  • Radiation Oncology Centers of Nevada Central
  • Urology Specialists of Nevada - Central
  • GenesisCare USA - Las Vegas
  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
  • Sunrise Hospital and Medical Center
  • HealthCare Partners Medical Group Oncology/Hematology-San Martin
  • Las Vegas Prostate Cancer Center
  • Las Vegas Urology - Sunset
  • Urology Specialists of Nevada - Southwest
  • Radiation Oncology Centers of Nevada Southeast
  • Ann M Wierman MD LTD
  • Comprehensive Cancer Centers of Nevada - Northwest
  • GenesisCare USA - Vegas Tenaya
  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
  • Las Vegas Urology - Cathedral Rock
  • Las Vegas Urology - Smoke Ranch
  • OptumCare Cancer Care at MountainView
  • Urology Specialists of Nevada - Northwest
  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
  • Comprehensive Cancer Centers of Nevada - Town Center
  • Comprehensive Cancer Centers of Nevada-Summerlin
  • Summerlin Hospital Medical Center
  • Las Vegas Cancer Center-Medical Center
  • Comprehensive Cancer Centers of Nevada
  • GenesisCare USA - Fort Apache
  • OptumCare Cancer Care at Fort Apache
  • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
  • Comprehensive Cancer Centers of Nevada - Central Valley
  • University Cancer Center
  • Hope Cancer Care of Nevada-Pahrump
  • Renown Regional Medical Center
  • Saint Mary's Regional Medical Center
  • Radiation Oncology Associates
  • Roswell Park Cancer Institute
  • Northwell Health/Center for Advanced Medicine
  • North Shore University Hospital
  • Long Island Jewish Medical Center
  • NYP/Weill Cornell Medical Center
  • University of Rochester
  • UNC Lineberger Comprehensive Cancer Center
  • Duke University Medical Center
  • East Carolina University
  • Wake Forest University Health Sciences
  • University of Cincinnati Cancer Center-UC Medical Center
  • Ohio State University Comprehensive Cancer Center
  • University of Cincinnati Cancer Center-West Chester
  • University of Oklahoma Health Sciences Center
  • Mercy Hospital Oklahoma City
  • Saint Charles Health System
  • Clackamas Radiation Oncology Center
  • Providence Cancer Institute Clackamas Clinic
  • Bay Area Hospital
  • Providence Newberg Medical Center
  • Providence Portland Medical Center
  • Providence Saint Vincent Medical Center
  • Oregon Health and Science University
  • Saint Charles Health System-Redmond
  • Lehigh Valley Hospital-Cedar Crest
  • Lehigh Valley Hospital - Muhlenberg
  • Christiana Care Health System-Concord Health Center
  • Pocono Medical Center
  • Lehigh Valley Hospital-Hazleton
  • Thomas Jefferson University Hospital
  • Virginia Commonwealth University/Massey Cancer Center
  • Providence Regional Cancer System-Aberdeen
  • Overlake Medical Center
  • PeaceHealth Saint Joseph Medical Center
  • Providence Regional Cancer System-Centralia
  • Swedish Cancer Institute-Edmonds
  • Providence Regional Cancer Partnership
  • Swedish Cancer Institute-Issaquah
  • Kadlec Clinic Hematology and Oncology
  • Providence Regional Cancer System-Lacey
  • PeaceHealth Saint John Medical Center
  • Valley Medical Center
  • Pacific Gynecology Specialists
  • Swedish Medical Center-Ballard Campus
  • Swedish Medical Center-Cherry Hill
  • Swedish Medical Center-First Hill
  • PeaceHealth United General Medical Center
  • Providence Regional Cancer System-Shelton
  • PeaceHealth Southwest Medical Center
  • Providence Saint Mary Regional Cancer Center
  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
  • Providence Regional Cancer System-Yelm
  • West Virginia University Healthcare
  • Marshfield Medical Center-EC Cancer Center
  • University of Wisconsin Carbone Cancer Center
  • Marshfield Medical Center-Marshfield
  • Medical College of Wisconsin
  • Marshfield Clinic-Minocqua Center
  • Marshfield Medical Center-Rice Lake
  • Marshfield Medical Center-River Region at Stevens Point
  • Marshfield Medical Center - Weston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1 (inotuzumab ozogamicin, blinatumomab)

Cohort 2 (inotuzumab ozogamicin, blinatumomab)

Arm Description

See Detailed Description

See Detailed Description.

Outcomes

Primary Outcome Measures

Event-free survival
Will be defined as time from start of treatment to failure to achieve complete response (CR)/complete response with incomplete count recovery (CRi) after completing Course II of blinatumomab, relapse after CR/CRi, progression on study requiring withdrawal from study therapy, or death from any cause

Secondary Outcome Measures

Overall survival (OS)
Will be evaluated using the Kaplan-Meier method. A 95% confidence interval for the 1- and 3-year rates will be constructed using a point-wise confidence interval for the survival function based on a log-minus-log transformation. Will also calculate a 95% confidence interval by using a point-wise confidence interval for the survival function based on a log-minus-log transformation.
Relapse-free survival (RFS)
Will be evaluated using the Kaplan-Meier method. A 95% confidence interval for the 1- and 3-year rates will be constructed using a point-wise confidence interval for the survival function based on a log-minus-log transformation. Will also calculate a 95% confidence interval by using a point-wise confidence interval for the survival function based on a log-minus-log transformation.
Event-free survival (EFS)
Will be evaluated using the Kaplan-Meier method. A 95% confidence interval for the 1- and 3-year rates will be constructed using a point-wise confidence interval for the survival function based on a log-minus-log transformation. Will also calculate a 95% confidence interval by using a point-wise confidence interval for the survival function based on a log-minus-log transformation.
Complete and overall response rate
Point and interval estimates of the rates will be shown using a 95% binomial confidence interval.
Minimal residual disease negativity
Allogeneic hematopoietic cell transplantation rate (Cohort 2)
Point and interval estimates of the rate will be shown using a 95% binomial confidence interval.

Full Information

First Posted
November 12, 2018
Last Updated
September 26, 2023
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03739814
Brief Title
Inotuzumab Ozogamicin and Blinatumomab in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
Official Title
A Phase II Study of Inotuzumab Ozogamicin Followed by Blinatumomab for Ph-Negative CD22-Positive B-Lineage Acute Lymphoblastic Leukemia in Newly Diagnosed Older Adults or Adults With Relapsed or Refractory Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Suspended
Why Stopped
Other - FDA Partial Clinical Hold
Study Start Date
May 8, 2019 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This phase II trial studies how well inotuzumab ozogamicin and blinatumomab work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back, or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin and blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Detailed Description
PRIMARY OBJECTIVES: I. To confirm tolerability of the combination regimen of inotuzumab ozogamicin followed by blinatumomab. II. To estimate the 1-year event-free survival of older, transplant-ineligible patients with newly diagnosed, Philadelphia (Ph)-negative, CD22-positive, B-cell acute lymphoblastic leukemia (ALL) treated with inotuzumab ozogamicin induction followed by blinatumomab consolidation. (Cohort 1) III. To estimate the 1-year event-free survival of patients with relapsed or refractory Ph-negative, CD22-positive, B-cell ALL treated with inotuzumab ozogamicin induction followed by blinatumomab consolidation. (Cohort 2) SECONDARY OBJECTIVES: I. To estimate the median, 1-year, and 3-year overall survival (OS) in all eligible patients. (Cohort 1) II. To estimate the median, 1-year, and 3-year relapse-free survival (RFS) in all eligible patients. (Cohort 1) III. To estimate the median and 3-year event-free survival (EFS) in all eligible patients. (Cohort 1) IV. To estimate the complete response (CR) rate and overall response rate (ORR, defined as complete response [CR] + complete response with incomplete count recovery [CRi]) to inotuzumab ozogamicin followed by blinatumomab (regimen CR rate and ORR). (Cohort 1) V. To estimate the CR rate and ORR (CR + CRi) to inotuzumab ozogamicin induction alone (induction CR and ORR). (Cohort 1) VI. To estimate the minimal residual disease (MRD) negativity rate in subjects achieving a CR or CRi. (Cohort 1) VII. To estimate the treatment-related mortality with this regimen. (Cohort 1) VIII. To describe the safety and tolerability of this regimen. (Cohort 1) IX. To estimate the median, 1-year, and 3-year OS in all eligible patients. (Cohort 2) X. To estimate the median, 1-year, and 3-year RFS in all eligible patients. (Cohort 2) XI. To estimate the median and 3-year EFS in all eligible patients. (Cohort 2) XII. To estimate ORR (CR/CRi and CR/complete response with partial hematologic recovery [CRh]) to blinatumomab in patients with ALL refractory to inotuzumab ozogamicin. (Cohort 2) XIII. To estimate the CR, CRi, and CRh rates at defined time points and cumulatively for the entire regimen. (Cohort 2) XIV. To determine the MRD negativity (< 10^-4) rate at defined time points including prior to allogeneic HCT and cumulatively in patients achieving a CR, CRh, or CRi. (Cohort 2) XV. To determine the allogeneic hematopoietic cell transplantation (HCT) rate in eligible subjects. (Cohort 2) XVI. To estimate the treatment-related mortality with this regimen. (Cohort 2) XVII. To describe the safety and tolerability of this regimen. (Cohort 2) OTHER OBJECTIVES: I. Results of the primary analysis will be examined for consistency, while accounting for the stratification factors and/or covariates of baseline quality of life (QOL) and fatigue. CORRELATIVE SCIENCE OBJECTIVES: I. To correlate specific karyotype groups (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters. II. To correlate specific karyotype groups with response rates, response duration, survival, and cure in patients treated with inotuzumab ozogamicin followed by blinatumomab. III. To correlate specific karyotype groups with MRD. IV. To determine karyotype changes at relapse and the influence of the type of change (or no change) in karyotype at relapse. V. To assess the correlation of quantitative MRD post-induction with inotuzumab ozogamicin and at sequential consolidation time points with blinatumomab with RFS, EFS, and OS. VI. To correlate the influence of MRD status (detectable versus [vs.] not and as a continuous measure) in relation to EFS, RFS, and OS with other clinical and biological factors (e.g. previously untreated vs. relapsed disease cohorts; age, initial white blood cell [WBC] count, cytogenetics). VII. To identify genetic variants and predictors of ex vivo resistance. VIII. To identify genetic variants and predictors of MRD. IX. To identify genetic variants and predictors of relapse. X. To determine inter-patient variability in drug sensitivity of adult ALL. XI. To examine the associations of drug sensitivity with host and leukemia molecular features. EXPLORATORY OBJECTIVES: I. To estimate the median, 1-year, and 3-year RFS, EFS, and OS in patients achieving a CR/CRi to inotuzumab ozogamicin. (Cohort 1) II. To compare the median, 1-year, and 3-year RFS, EFS, and OS among patients achieving MRD-negative vs. MRD-positive CR/CRi to inotuzumab ozogamicin. (Cohort 1) III. To compare the median, 1-year, and 3-year RFS, EFS, and OS among patients achieving MRD-negative vs. MRD-positive CR/CRi at any time. (Cohort 1) IV. To describe the rate, severity, and timing of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver after limited inotuzumab ozogamicin exposure and identify risk factors for SOS/VOD. (Cohort 1) V. To estimate the rate of cytokine release syndrome in this population. (Cohort 1) VI. To estimate the median, 1-year, and 3-year RFS from time of CR/CRi to inotuzumab ozogamicin in patients receiving inotuzumab ozogamicin followed by blinatumomab and not undergoing allogeneic hematopoietic cell transplantation (HCT). (Cohort 2) VII. To estimate median, 1-year, and 3-year OS after CR/CRi to inotuzumab ozogamicin in patients not undergoing allogeneic HCT. (Cohort 2) VIII. To compare in a non-randomized fashion median, 1-year, and 3-year OS, median, 1-year, and 3-year RFS, cumulative incidence of relapse (CIR), and non-relapse mortality (NRM) between patients achieving CR/CRi and receiving consolidation with or without allogeneic HCT. (Cohort 2) IX. To describe the rate, severity, and timing of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver after limited inotuzumab ozogamicin exposure and identify risk factors for SOS/VOD. (Cohort 2) X. To estimate the rate of cytokine release syndrome in this population. (Cohort 2) OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT 1: Patients receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day 1, 8, and 15 (Course IA). By the end of Course IA (day 21), patients with adequate ALL cytoreduction continue to Course IB/IC, and patients who fail to achieve ALL cytoreduction continue to Course II. By the end of Course II, patients with CR-CRi to Course IB/IC and Course II continue to Course IIIA, patients without adequate ALL cytoreduction to Course IA or refractory to Course IB/IC but CR/CRi to Course II continue to Course IIIB. COHORT 2: Patients receive inotuzumab ozogamicin IV over 1 hour on day 1, 8, and 15 (Course IA). By the end of Course IA (day 21), patients with adequate ALL cytoreduction continue to Course IB/IC, and patients who fail to achieve ALL cytoreduction continue to Course II. Patients with CR/CRi at the end of Course II continue to Course IIIB. COURSE IB/IC: Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Treatment continues for 1 course (28 days) in the absence of disease progression or unacceptable toxicity. COURSE II: Patients receive blinatumomab IV continuously on days 1-28 and 43-70. Treatment continues for 1 course (84 days) in the absence of disease progression or unacceptable toxicity. COURSE IIIA: Patients receive blinatumomab IV continuously on days 1-28 and 43-70. Treatment continues for 1 course (84 days) in the absence of disease progression or unacceptable toxicity. COURSE IIIB: Patients receive blinatumomab IV continuously on days 1-28, 43-70, and 85-112. Treatment continues for 1 course (126 days) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 3 years, and then every 6 months for up to 10 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, Recurrent B Acute Lymphoblastic Leukemia, Refractory B Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 (inotuzumab ozogamicin, blinatumomab)
Arm Type
Experimental
Arm Description
See Detailed Description
Arm Title
Cohort 2 (inotuzumab ozogamicin, blinatumomab)
Arm Type
Experimental
Arm Description
See Detailed Description.
Intervention Type
Biological
Intervention Name(s)
Blinatumomab
Other Intervention Name(s)
AMG 103, Anti-CD19 x Anti-CD3 Bispecific Monoclonal Antibody, Anti-CD19/Anti-CD3 Recombinant Bispecific Monoclonal Antibody MT103, Blincyto, MEDI-538, MEDI538, MT-103, MT103
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Inotuzumab Ozogamicin
Other Intervention Name(s)
Besponsa, CMC-544, Way 207294, WAY-207294
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Event-free survival
Description
Will be defined as time from start of treatment to failure to achieve complete response (CR)/complete response with incomplete count recovery (CRi) after completing Course II of blinatumomab, relapse after CR/CRi, progression on study requiring withdrawal from study therapy, or death from any cause
Time Frame
At 1 year
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Will be evaluated using the Kaplan-Meier method. A 95% confidence interval for the 1- and 3-year rates will be constructed using a point-wise confidence interval for the survival function based on a log-minus-log transformation. Will also calculate a 95% confidence interval by using a point-wise confidence interval for the survival function based on a log-minus-log transformation.
Time Frame
Time from start of study therapy to death from any cause censored at the last known alive date, assessed up to 10 years
Title
Relapse-free survival (RFS)
Description
Will be evaluated using the Kaplan-Meier method. A 95% confidence interval for the 1- and 3-year rates will be constructed using a point-wise confidence interval for the survival function based on a log-minus-log transformation. Will also calculate a 95% confidence interval by using a point-wise confidence interval for the survival function based on a log-minus-log transformation.
Time Frame
Time from first CR/CRi to progressive disease (relapse, treatment discontinuation due to health deterioration) or death, assessed up to 10 years
Title
Event-free survival (EFS)
Description
Will be evaluated using the Kaplan-Meier method. A 95% confidence interval for the 1- and 3-year rates will be constructed using a point-wise confidence interval for the survival function based on a log-minus-log transformation. Will also calculate a 95% confidence interval by using a point-wise confidence interval for the survival function based on a log-minus-log transformation.
Time Frame
Time from start of treatment to failure to achieve CR/CRi after completing Course II of blinatumomab, relapse after CR/CRi, progression on study requiring withdrawal from study therapy, or death from any cause, assessed up to 10 years
Title
Complete and overall response rate
Description
Point and interval estimates of the rates will be shown using a 95% binomial confidence interval.
Time Frame
Up to 10 years
Title
Minimal residual disease negativity
Time Frame
Up to 10 years
Title
Allogeneic hematopoietic cell transplantation rate (Cohort 2)
Description
Point and interval estimates of the rate will be shown using a 95% binomial confidence interval.
Time Frame
Up to 10 years
Other Pre-specified Outcome Measures:
Title
Rate of cytokine release syndrome (Cohort 1)
Description
Point and interval estimates of the rate will be shown using a 95% binomial confidence interval.
Time Frame
Up to 10 years
Title
Sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver
Description
The rate of, timing of, and risk factors for SOS/VOD of the liver after limited inotuzumab ozogamicin exposure. Point and interval estimates of the rate will be shown using a 95% binomial confidence interval. A summary of the timing and risk factors for SOS/VOD of the liver will be provided.
Time Frame
Up to 10 years
Title
OS
Description
Will compare between patients achieving CR/CRi and receiving consolidation with allogeneic hematopoietic cell transplantation versus (vs.) patients achieving CR/CRi and receiving consolidation without allogeneic hematopoietic cell transplantation. The median, 1-year, and 2-year OS will be compared between the above two groups. The distribution of OS for each group will be estimated using the Kaplan-Meier method.
Time Frame
Up to 2 years
Title
RFS
Description
Will compare between patients achieving CR/CRi and receiving consolidation with allogeneic hematopoietic cell transplantation vs. patients achieving CR/CRi and receiving consolidation without allogeneic hematopoietic cell transplantation. The median, 1-year, and 2-year RFS will be compared between the above two groups. The distribution of RFS for each treatment arm will be estimated using the Kaplan-Meier method.
Time Frame
Up to 2 years
Title
Cumulative incidence of relapse (CIR)
Description
Will compare between patients achieving CR/CRi and receiving consolidation with allogeneic hematopoietic cell transplantation vs. patients achieving CR/CRi and receiving consolidation without allogeneic hematopoietic cell transplantation. Competing risk analysis will be done to compare the relapse rates between the above two groups. In this analysis, death will be considered a competing event. Relapse rates at the 1-year and 2-year time points will be estimated. Other time points of interest may be estimated as well.
Time Frame
Up to 2 years
Title
Non-relapse mortality
Description
Will compare between patients achieving CR/CRi and receiving consolidation with allogeneic hematopoietic cell transplantation vs. patients achieving CR/CRi and receiving consolidation without allogeneic hematopoietic cell transplantation. Competing risk analysis will be done to compare the mortality rates between the above two groups. In this analysis, relapse will be considered a competing event. Mortality rates at the 1-year and 2-year time points will be estimated. Other time points may be estimated as well.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pre-registration Eligibility Criteria (Step 0) Submission of bone marrow aspirate and peripheral blood for MRD analysis is mandatory prior to registration; the bone marrow sample should be from the first aspiration (i.e. first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be initiated as soon as possible after pre-registration. The specimens should be sent to the HEME Biobank. Lumbar Puncture (Spinal Tap) and Intrathecal Methotrexate: Patients may receive the day 1 of course IA dose of intrathecal (IT) methotrexate during the prior-to-registration lumbar puncture (or the venous line placement) to avoid a second lumbar puncture. If the dose is administered prior to registration, then systemic chemotherapy must begin within 7 days of this IT chemotherapy. Registration Eligibility Criteria (Step 1) Morphologic diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL) based on World Health Organization (WHO) criteria. Patients with Burkitt lymphoma/leukemia are not eligible. CD22-positive disease defined as CD22 expression by >= 20% of lymphoblasts by local hematopathology evaluation. Philadelphia chromosome/BCR-ABL1-negative ALL by cytogenetics, fluorescence in situ hybridization (FISH), and/or polymerase chain reaction (PCR). If any test is positive for Philadelphia chromosome/BCR-ABL1, then the patient is ineligible. No active central nervous system (CNS) leukemia (i.e. only CNS-1 disease allowed). Active CNS leukemia is defined as morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS-directed local treatment for active disease within 28 days prior to registration, symptomatic CNS leukemia (i.e. cranial nerve palsies or other significant neurological dysfunction) within the 28 days prior to registration, and/or known asymptomatic parenchymal CNS mass lesions; see below for additional guidance. Prophylactic intrathecal medication alone is not an exclusion. Categories of CNS Involvement for CNS Evaluation Prior to Registration: CNS 1: CSF has < 5 WBC/uL with cytospin negative for blasts; or >= 10 red blood cell (RBC)/uL with cytospin negative for blasts. CNS 2: CSF has < 5 WBC/uL with cytospin positive for blasts; or >= 10 RBC/uL with cytospin positive for blasts; or >= 10 RBC/uL, WBC/uL >= 5 but less than Steinherz/Bleyer algorithm with cytospin positive for blasts (see below). CNS 3: CSF has >= 5 WBC/uL with cytospin positive for blasts; or >= 10 RBC/uL, >= 5 WBC/uL and positive by Steinherz/Bleyer algorithm (see below); or clinical signs of CNS leukemia (such as facial nerve palsy, brain/eye involvement or hypothalamic syndrome). Steinherz/Bleyer Method of Evaluating Initial Traumatic Lumbar Punctures: If the patient has leukemia cells in the peripheral blood and the lumbar puncture is traumatic and contains >= 5 WBC/uL with blasts, the following algorithm should be used to define CNS disease: CSF WBC/CSF RBC > 2 x (Blood WBC/Blood RBC count) Patients with known or suspected testicular involvement by leukemia are allowed provided that the patient receives concomitant scrotal/testicular radiotherapy. Unilateral or bilateral testicular enlargement should be assessed by ultrasound or other imaging technique. Biopsy is recommended if clinical findings are equivocal or suggestive of hydrocele or a non-leukemic mass, but further assessments are per treating physician discretion. Not pregnant and not nursing. This study involves agents that have known genotoxic, mutagenic, and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required. Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 No unstable cardiac disease such as myocardial infarction, angina pectoris, uncontrolled heart failure, or uncontrolled cardiac arrhythmia within 6 months of registration. No impaired cardiac function, defined as left ventricular ejection fraction (LVEF) < 45% or New York Heart Association (NYHA) stage III or IV congestive heart failure (CHF). Patients with known human immunodeficiency virus (HIV) infection are eligible if they have been on effective antiretroviral therapy with an undetectable viral load tested within 6 months of registration. Patients with hepatitis B virus (HBV) are eligible only if they meet all the following: On HBV-suppressive therapy. No evidence of active virus. No evidence of HBV-related liver damage. Patients with hepatitis C virus (HCV) are eligible only if they meet all the following: Successfully completed complete-eradication therapy with undetectable viral load. No evidence of HCV-related liver damage. No history of clinically relevant neurologic disorder such as epilepsy, seizure, aphasia, stroke, severe brain injury, structural brain abnormality, benign brain tumor, dementia, Parkinson's disease, movement disorder, cerebellar disease, or other significant CNS abnormalities. No prior additional malignancy (i.e. in addition to ALL) except adequately treated basal- or squamous-cell skin cancer, in situ cervical cancer, stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for >= 2 years. No history of clinically significant ventricular arrhythmia, unexplained non-vasovagal syncope, or chronic bradycardic states such as sinoatrial block or higher degree of atrioventricular block unless a permanent pacemaker has been implanted. No history of chronic liver disease, including cirrhosis. No history of sinusoidal occlusion syndrome/veno-occlusive disease of the liver. No uncontrolled infection or recent history (within 4 months prior to registration) of deep tissue infections such as fasciitis or osteomyelitis. Total bilirubin, serum =< 1.5 x upper limit of normal (ULN)* Except in the event of: 1) Gilbert disease, in which case total bilirubin must be =< 2 x ULN, or 2) elevated bilirubin believed by investigator to be due to leukemic infiltration, in which case total bilirubin must be =< 2 x ULN. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN Creatinine, serum =< 1.5 ULN OR creatinine clearance >= 40 mL/min QT interval by Fridericia's correction formula (QTcF) =< 470 msec Cohort 1 Patients Only Age >= 60 years. No prior treatment for ALL except a single dose of intrathecal chemotherapy, corticosteroids, hydroxyurea, and/or leukapheresis to reduce peripheral blast count and prevent ALL complications. Allowed therapy may be administered for no more than 14 days and must be completed >= 24 hours prior to the initiation of protocol therapy. No plan for allogeneic or autologous hematopoietic cell transplantation (HCT). Cohort 2 Patients Only: Age >= 18 years. Relapsed or refractory disease in salvage 1 or 2. No isolated extramedullary relapse. Prior allogeneic HCT permitted. Patients with prior allogeneic HCT must have completed transplantation >= 4 months prior to registration. Patients with prior allogeneic HCT must have no evidence of graft-versus-host disease and must have completed immunosuppressive therapy >= 30 days prior to registration. Prior treatment with inotuzumab ozogamicin, blinatumomab, other CD22-directed therapy, or other CD19-directed therapy is not allowed. Prior treatment with rituximab must be completed >= 7 days prior to registration. Prior treatment with other monoclonal antibodies must be completed >= 6 weeks prior to registration. Prior treatment for ALL must be completed >= 14 days prior to registration with the following exceptions: intrathecal chemotherapy, hydroxyurea, corticosteroids, 6-mercaptopurine, methotrexate, vincristine, and/or leukapheresis to reduce circulating absolute lymphoblast count to =< 10,000/uL or prevent complications related to ALL are allowed but must be completed >= 24 hours prior to the initiation of protocol therapy. Patients should have resolution of any acute non-hematologic toxicities of prior therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 grade =< 1. Peripheral blood absolute lymphoblast count =< 10,000/uL (treatment allowed as above to reduce blast count to =< 10,000/uL)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew J Wieduwilt
Organizational Affiliation
Alliance for Clinical Trials in Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Anchorage Associates in Radiation Medicine
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
98508
Country
United States
Facility Name
Anchorage Radiation Therapy Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99504
Country
United States
Facility Name
Alaska Breast Care and Surgery LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Alaska Oncology and Hematology LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Alaska Women's Cancer Care
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Anchorage Oncology Centre
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Katmai Oncology Group
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Kingman Regional Medical Center
City
Kingman
State/Province
Arizona
ZIP/Postal Code
86401
Country
United States
Facility Name
Mercy Hospital Fort Smith
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72903
Country
United States
Facility Name
PCR Oncology
City
Arroyo Grande
State/Province
California
ZIP/Postal Code
93420
Country
United States
Facility Name
Providence Saint Joseph Medical Center/Disney Family Cancer Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Community Cancer Institute
City
Clovis
State/Province
California
ZIP/Postal Code
93611
Country
United States
Facility Name
University Oncology Associates
City
Clovis
State/Province
California
ZIP/Postal Code
93611
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UC Irvine Health/Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford Cancer Institute Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Beebe South Coastal Health Campus
City
Frankford
State/Province
Delaware
ZIP/Postal Code
19945
Country
United States
Facility Name
Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
Delaware Clinical and Laboratory Physicians PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Helen F Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Medical Oncology Hematology Consultants PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Christiana Care Health System-Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Beebe Health Campus
City
Rehoboth Beach
State/Province
Delaware
ZIP/Postal Code
19971
Country
United States
Facility Name
TidalHealth Nanticoke / Allen Cancer Center
City
Seaford
State/Province
Delaware
ZIP/Postal Code
19973
Country
United States
Facility Name
Christiana Care Health System-Wilmington Hospital
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19801
Country
United States
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Emory University Hospital/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Saint Luke's Cancer Institute - Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Saint Luke's Cancer Institute - Fruitland
City
Fruitland
State/Province
Idaho
ZIP/Postal Code
83619
Country
United States
Facility Name
Saint Luke's Cancer Institute - Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Saint Luke's Cancer Institute - Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Saint Luke's Cancer Institute - Twin Falls
City
Twin Falls
State/Province
Idaho
ZIP/Postal Code
83301
Country
United States
Facility Name
Saint Anthony's Health
City
Alton
State/Province
Illinois
ZIP/Postal Code
62002
Country
United States
Facility Name
Illinois CancerCare-Bloomington
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Loyola Center for Health at Burr Ridge
City
Burr Ridge
State/Province
Illinois
ZIP/Postal Code
60527
Country
United States
Facility Name
Illinois CancerCare-Canton
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Memorial Hospital of Carbondale
City
Carbondale
State/Province
Illinois
ZIP/Postal Code
62902
Country
United States
Facility Name
SIH Cancer Institute
City
Carterville
State/Province
Illinois
ZIP/Postal Code
62918
Country
United States
Facility Name
Illinois CancerCare-Carthage
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Centralia Oncology Clinic
City
Centralia
State/Province
Illinois
ZIP/Postal Code
62801
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Cancer Care Specialists of Illinois - Decatur
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Illinois CancerCare-Dixon
City
Dixon
State/Province
Illinois
ZIP/Postal Code
61021
Country
United States
Facility Name
Crossroads Cancer Center
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
Illinois CancerCare-Eureka
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Illinois CancerCare-Galesburg
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Western Illinois Cancer Treatment Center
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Loyola Medicine Homer Glen
City
Homer Glen
State/Province
Illinois
ZIP/Postal Code
60491
Country
United States
Facility Name
Illinois CancerCare-Kewanee Clinic
City
Kewanee
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Facility Name
Northwestern Medicine Lake Forest Hospital
City
Lake Forest
State/Province
Illinois
ZIP/Postal Code
60045
Country
United States
Facility Name
Illinois CancerCare-Macomb
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
City
Melrose Park
State/Province
Illinois
ZIP/Postal Code
60160
Country
United States
Facility Name
Good Samaritan Regional Health Center
City
Mount Vernon
State/Province
Illinois
ZIP/Postal Code
62864
Country
United States
Facility Name
UC Comprehensive Cancer Center at Silver Cross
City
New Lenox
State/Province
Illinois
ZIP/Postal Code
60451
Country
United States
Facility Name
Cancer Care Center of O'Fallon
City
O'Fallon
State/Province
Illinois
ZIP/Postal Code
62269
Country
United States
Facility Name
University of Chicago Medicine-Orland Park
City
Orland Park
State/Province
Illinois
ZIP/Postal Code
60462
Country
United States
Facility Name
Illinois CancerCare-Ottawa Clinic
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Illinois CancerCare-Pekin
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Illinois CancerCare-Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Illinois CancerCare-Peru
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Valley Radiation Oncology
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Illinois CancerCare-Princeton
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
Facility Name
Illinois CancerCare - Washington
City
Washington
State/Province
Illinois
ZIP/Postal Code
61571
Country
United States
Facility Name
Central Care Cancer Center - Garden City
City
Garden City
State/Province
Kansas
ZIP/Postal Code
67846
Country
United States
Facility Name
Central Care Cancer Center - Great Bend
City
Great Bend
State/Province
Kansas
ZIP/Postal Code
67530
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kansas Hospital-Westwood Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Ochsner Medical Center Jefferson
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Maryland/Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Mercy Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Saint Joseph Mercy Brighton
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48114
Country
United States
Facility Name
Trinity Health IHA Medical Group Hematology Oncology - Brighton
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48114
Country
United States
Facility Name
Saint Joseph Mercy Canton
City
Canton
State/Province
Michigan
ZIP/Postal Code
48188
Country
United States
Facility Name
Trinity Health IHA Medical Group Hematology Oncology - Canton
City
Canton
State/Province
Michigan
ZIP/Postal Code
48188
Country
United States
Facility Name
Caro Cancer Center
City
Caro
State/Province
Michigan
ZIP/Postal Code
48723
Country
United States
Facility Name
Saint Joseph Mercy Chelsea
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Facility Name
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Facility Name
Hematology Oncology Consultants-Clarkston
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Newland Medical Associates-Clarkston
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Ascension Saint John Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Great Lakes Cancer Management Specialists-Doctors Park
City
East China Township
State/Province
Michigan
ZIP/Postal Code
48054
Country
United States
Facility Name
Genesee Cancer and Blood Disease Treatment Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Genesee Hematology Oncology PC
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Academic Hematology Oncology Specialists
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Michigan Breast Specialists-Grosse Pointe Woods
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Hope Cancer Clinic
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
Trinity Health Saint Mary Mercy Livonia Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
Great Lakes Cancer Management Specialists-Macomb Medical Campus
City
Macomb
State/Province
Michigan
ZIP/Postal Code
48044
Country
United States
Facility Name
Michigan Breast Specialists-Macomb Township
City
Macomb
State/Province
Michigan
ZIP/Postal Code
48044
Country
United States
Facility Name
Saint Mary's Oncology/Hematology Associates of Marlette
City
Marlette
State/Province
Michigan
ZIP/Postal Code
48453
Country
United States
Facility Name
21st Century Oncology-Pontiac
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Hope Cancer Center
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Newland Medical Associates-Pontiac
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Saint Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Great Lakes Cancer Management Specialists-Rochester Hills
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48309
Country
United States
Facility Name
Ascension Saint Mary's Hospital
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Oncology Hematology Associates of Saginaw Valley PC
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Bhadresh Nayak MD PC-Sterling Heights
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48312
Country
United States
Facility Name
Ascension Saint Joseph Hospital
City
Tawas City
State/Province
Michigan
ZIP/Postal Code
48764
Country
United States
Facility Name
Advanced Breast Care Center PLLC
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Great Lakes Cancer Management Specialists-Macomb Professional Building
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Macomb Hematology Oncology PC
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Michigan Breast Specialists-Warren
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Saint John Macomb-Oakland Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Saint Mary's Oncology/Hematology Associates of West Branch
City
West Branch
State/Province
Michigan
ZIP/Postal Code
48661
Country
United States
Facility Name
Huron Gastroenterology PC
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Saint Louis Cancer and Breast Institute-Ballwin
City
Ballwin
State/Province
Missouri
ZIP/Postal Code
63011
Country
United States
Facility Name
Central Care Cancer Center - Bolivar
City
Bolivar
State/Province
Missouri
ZIP/Postal Code
65613
Country
United States
Facility Name
Cox Cancer Center Branson
City
Branson
State/Province
Missouri
ZIP/Postal Code
65616
Country
United States
Facility Name
Saint Francis Medical Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
Southeast Cancer Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
Siteman Cancer Center at West County Hospital
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Parkland Health Center - Farmington
City
Farmington
State/Province
Missouri
ZIP/Postal Code
63640
Country
United States
Facility Name
Capital Region Southwest Campus
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Freeman Health System
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
Mercy Hospital Joplin
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
Delbert Day Cancer Institute at PCRMC
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Mercy Clinic-Rolla-Cancer and Hematology
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Heartland Regional Medical Center
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Saint Louis Cancer and Breast Institute-South City
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercy Hospital South
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Siteman Cancer Center-South County
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63129
Country
United States
Facility Name
Missouri Baptist Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Siteman Cancer Center at Christian Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Mercy Hospital Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Siteman Cancer Center at Saint Peters Hospital
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Sainte Genevieve County Memorial Hospital
City
Sainte Genevieve
State/Province
Missouri
ZIP/Postal Code
63670
Country
United States
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
CoxHealth South Hospital
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Missouri Baptist Sullivan Hospital
City
Sullivan
State/Province
Missouri
ZIP/Postal Code
63080
Country
United States
Facility Name
Missouri Baptist Outpatient Center-Sunset Hills
City
Sunset Hills
State/Province
Missouri
ZIP/Postal Code
63127
Country
United States
Facility Name
Mercy Hospital Washington
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Saint Patrick Hospital - Community Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Nebraska Medicine-Village Pointe
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68118
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Carson Tahoe Regional Medical Center
City
Carson City
State/Province
Nevada
ZIP/Postal Code
89703
Country
United States
Facility Name
Cancer and Blood Specialists-Henderson
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada - Henderson
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada-Horizon Ridge
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Las Vegas Cancer Center-Henderson
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
OptumCare Cancer Care at Seven Hills
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada-Southeast Henderson
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
GenesisCare USA - Henderson
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Las Vegas Urology - Green Valley
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Las Vegas Urology - Pebble
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Urology Specialists of Nevada - Green Valley
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Las Vegas Urology - Pecos
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Desert West Surgery
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
OptumCare Cancer Care at Charleston
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
University Medical Center of Southern Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Hope Cancer Care of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89103
Country
United States
Facility Name
Radiation Oncology Centers of Nevada Central
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Urology Specialists of Nevada - Central
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
GenesisCare USA - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Sunrise Hospital and Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
HealthCare Partners Medical Group Oncology/Hematology-San Martin
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Las Vegas Prostate Cancer Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Las Vegas Urology - Sunset
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Urology Specialists of Nevada - Southwest
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Radiation Oncology Centers of Nevada Southeast
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Ann M Wierman MD LTD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada - Northwest
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
GenesisCare USA - Vegas Tenaya
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Las Vegas Urology - Cathedral Rock
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Las Vegas Urology - Smoke Ranch
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
OptumCare Cancer Care at MountainView
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Urology Specialists of Nevada - Northwest
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada - Town Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada-Summerlin
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Summerlin Hospital Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Las Vegas Cancer Center-Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148-2405
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
GenesisCare USA - Fort Apache
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
OptumCare Cancer Care at Fort Apache
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89149
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada - Central Valley
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
University Cancer Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Hope Cancer Care of Nevada-Pahrump
City
Pahrump
State/Province
Nevada
ZIP/Postal Code
89048
Country
United States
Facility Name
Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Saint Mary's Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89503
Country
United States
Facility Name
Radiation Oncology Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Northwell Health/Center for Advanced Medicine
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
NYP/Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Cincinnati Cancer Center-UC Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Cincinnati Cancer Center-West Chester
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Mercy Hospital Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Saint Charles Health System
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Clackamas Radiation Oncology Center
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Providence Cancer Institute Clackamas Clinic
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Bay Area Hospital
City
Coos Bay
State/Province
Oregon
ZIP/Postal Code
97420
Country
United States
Facility Name
Providence Newberg Medical Center
City
Newberg
State/Province
Oregon
ZIP/Postal Code
97132
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Providence Saint Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Saint Charles Health System-Redmond
City
Redmond
State/Province
Oregon
ZIP/Postal Code
97756
Country
United States
Facility Name
Lehigh Valley Hospital-Cedar Crest
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Lehigh Valley Hospital - Muhlenberg
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Christiana Care Health System-Concord Health Center
City
Chadds Ford
State/Province
Pennsylvania
ZIP/Postal Code
19317
Country
United States
Facility Name
Pocono Medical Center
City
East Stroudsburg
State/Province
Pennsylvania
ZIP/Postal Code
18301
Country
United States
Facility Name
Lehigh Valley Hospital-Hazleton
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Providence Regional Cancer System-Aberdeen
City
Aberdeen
State/Province
Washington
ZIP/Postal Code
98520
Country
United States
Facility Name
Overlake Medical Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
PeaceHealth Saint Joseph Medical Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Providence Regional Cancer System-Centralia
City
Centralia
State/Province
Washington
ZIP/Postal Code
98531
Country
United States
Facility Name
Swedish Cancer Institute-Edmonds
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
Facility Name
Providence Regional Cancer Partnership
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Swedish Cancer Institute-Issaquah
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98029
Country
United States
Facility Name
Kadlec Clinic Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Providence Regional Cancer System-Lacey
City
Lacey
State/Province
Washington
ZIP/Postal Code
98503
Country
United States
Facility Name
PeaceHealth Saint John Medical Center
City
Longview
State/Province
Washington
ZIP/Postal Code
98632
Country
United States
Facility Name
Valley Medical Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
Pacific Gynecology Specialists
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Swedish Medical Center-Ballard Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98107
Country
United States
Facility Name
Swedish Medical Center-Cherry Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-5711
Country
United States
Facility Name
Swedish Medical Center-First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
PeaceHealth United General Medical Center
City
Sedro-Woolley
State/Province
Washington
ZIP/Postal Code
98284
Country
United States
Facility Name
Providence Regional Cancer System-Shelton
City
Shelton
State/Province
Washington
ZIP/Postal Code
98584
Country
United States
Facility Name
PeaceHealth Southwest Medical Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Providence Saint Mary Regional Cancer Center
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
Providence Regional Cancer System-Yelm
City
Yelm
State/Province
Washington
ZIP/Postal Code
98597
Country
United States
Facility Name
West Virginia University Healthcare
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Marshfield Medical Center-EC Cancer Center
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Marshfield Medical Center-Marshfield
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Marshfield Clinic-Minocqua Center
City
Minocqua
State/Province
Wisconsin
ZIP/Postal Code
54548
Country
United States
Facility Name
Marshfield Medical Center-Rice Lake
City
Rice Lake
State/Province
Wisconsin
ZIP/Postal Code
54868
Country
United States
Facility Name
Marshfield Medical Center-River Region at Stevens Point
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54482
Country
United States
Facility Name
Marshfield Medical Center - Weston
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35622074
Citation
Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704.
Results Reference
derived

Learn more about this trial

Inotuzumab Ozogamicin and Blinatumomab in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia

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