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IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia

Primary Purpose

Acute Myeloid Leukemia

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Azacitidine
IMGN632
Venetoclax
Sponsored by
ImmunoGen, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute Myeloid Leukemia, AML, Minimal detectable disease, MRD, CD123, Relapsed/refractory, Frontline

Eligibility Criteria

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

Patient Inclusion Criteria

  1. Patient must be ≥ 18 years of age.
  2. Patients must have confirmed diagnosis of AML (excluding acute promyelocytic leukemia) based on World Health Organization classification (Arber 2016).
  3. Disease characteristics and allowable prior therapy:

    1. Patients must be evaluated for any available standard of care therapies and, in the opinion of the treating physician, be deemed appropriate for this experimental therapy.
    2. Treatment-naïve (untreated) patients will be allowed in the Expansion Phase for Regimens A (IMGN632 + azacitidine) and C (IMGN632 + azacitidine + venetoclax). No prior treatments with HMAs for MDS are allowed. Note: Patients who are MRD+ following frontline treatment are eligible for the Regimen D Cohorts D1 and D2 (Expansion Phase).
    3. Patients must have CD123-positive AML as confirmed by local flow cytometry (or immunohistochemistry [IHC]).
    4. Patients may have received prior CD123-targeted therapies, except IMGN632, as long as CD123 remains detectable during screening.
    5. Relapsed or refractory CD123-positive AML patients will be allowed to enroll in the Escalation Phase of Regimens A, B, and C (Triplet) (IMGN632 + azacitidine, venetoclax, or azacitidine + venetoclax, respectively) and relapsed CD123-positive AML patients will be allowed to enroll the Expansion Phase of Regimens A-C.
    6. Patients enrolling in Regimen D must be in CR (CR/CRi) for no more than 6 months and be MRD+, confirmed by central laboratory testing, after intensive induction/consolidation therapy. Note: Fit patients who previously received intensive treatment (eg 3+7, HiDAC, etc.) are eligible for Regimen D Cohort D1. Unfit patients who previously received non-intensive treatment (eg, HMA, low dose cytarabine, etc.) are eligible for Regimen D Cohort D2.
  4. Patients enrolling on Regimen D (MRD+ AML), must first have an evaluable screening bone marrow sample confirmed as MRD+ by central flow testing of MRD.
  5. Eastern Cooperative Oncology Group performance status ≤ 1. If nonambulatory due to a chronic disability, must be Karnofsky performance status > 70.
  6. Previous treatment-related toxicities must have resolved to Grade 1 or baseline (excluding alopecia).
  7. Total white blood cell count must be less than 25 x 10^9 cells/L. Hydroxyurea may be used to control blood counts before Cycle 1 Day 1, at the discretion of the treating physician, according to institutional practice. During the Escalation Phase in Regimens A-C, hydroxyurea may also be used during Cycle 1.
  8. Liver enzymes (AST and ALT) ≤ 3 × the upper limit of normal (ULN).
  9. Total bilirubin ≤ 1.5 × the ULN within 14 days of enrollment.
  10. Serum creatinine ≤ 1.5 mg/dL within 14 days of enrollment.
  11. Echocardiogram or other modality demonstrating an ejection fraction ≥ 45%.
  12. Patients with prior autologous and allogeneic bone marrow transplant are eligible. Patients with an allogeneic transplant must meet the following conditions: The transplant must have been performed more than 120 days before the date of dosing on this study, the patient must not have active ≥ Grade 2 graft versus host disease, and the patient must be off all systemic immunosuppression for at least 2 weeks before dosing.
  13. Voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
  14. Women of childbearing potential (WCBP), defined as sexually mature women who have not undergone surgical sterilization or who have not been naturally postmenopausal for at least 12 consecutive months (ie, who have had menses any time in the preceding 12 consecutive months), must agree to use highly effective contraceptive methods (examples include oral, parenteral, or implantable hormonal contraceptive, intrauterine device, barrier contraceptive with spermicide, partner's latex condom or vasectomy) while on study drug and for at least 7 months after the last dose of study drug.
  15. WCBP must have a negative pregnancy test within 3 days before the first dose of study drug.
  16. A male patient must agree to use a latex condom even if he has had a successful vasectomy and must continue to follow these requirements for at least 12 weeks after the last dose of study drug.
  17. Patients with prior malignancy are eligible; however, the patient must be in remission from the prior malignancy and have completed all chemotherapy and radiotherapy for the prior malignancy at least 6 months before enrollment, and all treatment-related toxicities must have resolved to Grade 1 or less.

Patient Exclusion Criteria

  1. Patients who have received any anticancer therapy, including investigational agents, within 14 days (or within 28 days for checkpoint inhibitors) before drug administration on this study (hydroxyurea is allowed before beginning study treatment). Patients must have recovered to baseline from all acute toxicity from this prior therapy.
  2. Patients who have been previously treated with IMGN632.
  3. Patients with myeloproliferative neoplasm-related secondary AML are excluded from the Dose Expansion Phase of the study.
  4. Patients with active central nervous system (CNS) AML will be excluded. A lumbar puncture does not need to be performed unless there is clinical suspicion of CNS involvement per investigator judgement. Concurrent therapy for CNS prophylaxis or continuation of therapy for controlled CNS AML is allowed with the approval of the sponsor.
  5. Patients with a history of sinusoidal obstruction syndrome/venous occlusive disease of the liver.
  6. Myocardial infarction within 6 months before enrollment or New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities before study entry.
  7. Clinically relevant active infection including known active hepatitis B or C, HIV infection, or cytomegalovirus or any other known concurrent infectious disease that, in the judgment of the investigator, would make a patient inappropriate for enrollment into this study (testing not required).
  8. Patients who have undergone a major surgery within 4 weeks (or longer if not fully recovered) before study enrollment.
  9. Serious or poorly controlled medical conditions that could be exacerbated by treatment or that would seriously compromise safety assessment or compliance with the protocol, in the judgment of the investigator.
  10. Women who are pregnant or breastfeeding.
  11. Prior known hypersensitivity reactions to monoclonal antibodies (≥ Grade 3).
  12. Prior known hypersensitivity reactions to study drugs and/or any of their excipients

Sites / Locations

  • City of Hope Comprehensive Cancer CenterRecruiting
  • UC Irvine Medical CenterRecruiting
  • Moffitt Cancer CenterRecruiting
  • Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Dana-Farber Cancer InstituteRecruiting
  • University of Michigan HospitalRecruiting
  • Mayo Clinic Hospital - Rochester St. Mary's CampusRecruiting
  • Roswell Park Comprehensive Cancer CenterRecruiting
  • NewYork-Presbyterian - Weill CornellRecruiting
  • Duke University Health System
  • Cleveland ClinicRecruiting
  • MD AndersonRecruiting
  • Fred Hutchinson Cancer Research CenterRecruiting
  • Hospices Civils de Lyon, Lyon-Sud HospitalRecruiting
  • Institute Paoli-CalmettesRecruiting
  • Centre Antoine LacassagneRecruiting
  • Hôspital Saint-LouisRecruiting
  • CHU de ToulouseRecruiting
  • Hôpital André MignotRecruiting
  • University Hospital LeipzigRecruiting
  • University Hospital MuensterRecruiting
  • University Hospital of UlmRecruiting
  • Istituto di Ematologia "Lorenzo e A. Seragnoli" - Policlinco S. Orsola - MalpighiRecruiting
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)Recruiting
  • European Institute of Oncology IRCCSRecruiting
  • Azienda Ospedaliera Universitaria Maggiore Della Carita NovaraRecruiting
  • MD Anderson Cancer Center Madrid, SpainRecruiting
  • Hospital Universitario y Politécnico de La FeRecruiting
  • Oxford University Hospital - Churchill HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Regimen A (Closed to Enrollment)

Regimen B (Closed to Enrollment)

Regimen C - Frontline (Enrolling) & Relapsed / Refractory (Closed to Enrollment)

Regimen D (Closed to Enrollment)

Arm Description

IMGN632, administered intravenously on Day 7 of a 28 day cycle at 0.015 mg/kg, 0.045 mg/kg, or 0.09 mg/kg, in combination with azacitidine, administered subcutaneously or intravenously daily at 75 mg/m2 on Days 1 to 7 of a 28 day cycle. Cycle 1 azacitidine dose in subsequent cohorts may be reduced.

IMGN632, administered intravenously on Day 7 of a 21 day cycle at 0.015 mg/kg, 0.045 mg/kg, or 0.09 mg/kg, in combination with venetoclax, administered orally daily at 100 mg on Day 1, 200mg on Day 2, and 400 mg on the day 3 up to Day 21 of a 21 day cycle. Alternate schedules with reduced venetoclax administration may be explored.

IMGN632, administered intravenously on Day 7 of a 28 day cycle at 0.015 mg/kg or 0.045 mg/kg, in combination with azacitidine, administered subcutaneously or intravenously daily at 35-75 mg/m2 given for Days 1 to 7 of a 28 day cycle and venetoclax, administered orally daily at 100 mg on Day 1, 200mg on Day 2, and 400 mg on Day 3 up to Day 28 of a 28 day cycle. Alternate schedules with reduced venetoclax administration or reduced azacitidine dose or administration may be explored.

IMGN632, administered intravenously on Day 1 of a 21 day cycle at 0.045 mg/kg, as a monotherapy for Fit and Unfit MRD+ patients.

Outcomes

Primary Outcome Measures

Safety and Tolerability
Evaluate the safety and tolerability and identify an RP2D of IMGN632 when administered in combination with azacitidine, with venetoclax, and with azacitidine and venetoclax in patients with relapsed or refractory CD123-positive AML through review of Treatment Emergent Adverse Events and abnormal laboratory values that result in a failure to meet the criteria for re-treatment.
Preliminary antileukemia activity
Assess preliminary antileukemia activity of IMGN632 when administered as a monotherapy in MRD+ Fit and MRD+ Unfit AML patient populations, and in combination with azacitidine, with venetoclax, and with azacitidine and venetoclax in patients with relapsed or untreated AML as assessed by complete response, complete remission with partial hematologic recovery, complete remission with incomplete platelet recovery, morphologic leukemia-free state, partial response, and duration of remission.
Minimal Residual Disease Levels
Assess Minimal Residual Disease Levels using central flow cytometry-based testing.

Secondary Outcome Measures

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (Dose Expansion Phase)
Study Drug Concentration (Dose Escalation and Expansion)
Anti-drug Antibody Concentration (Dose Escalation and Expansion)
Minimal Residual Disease Levels (Dose Escalation)

Full Information

First Posted
September 9, 2019
Last Updated
October 4, 2023
Sponsor
ImmunoGen, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04086264
Brief Title
IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia
Official Title
A Phase 1b/2 Study of IMGN632 as Monotherapy or Combination With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 6, 2019 (Actual)
Primary Completion Date
December 11, 2024 (Anticipated)
Study Completion Date
December 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmunoGen, Inc.

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 is an open-label, multicenter, Phase 1b/2 study to determine the safety and tolerability of IMGN632 and assess the antileukemia activity of IMGN632 when administered in combination with azacitidine and/or venetoclax in participants with relapsed and frontline CD123-positive AML.
Detailed Description
This study explores multiple IMGN632 doses in combination and monotherapy Regimens, including (A - closed to enrollment)) azacitidine, (B-closed to enrollment) venetoclax, (C) azacitidine+venetoclax, and (D- closed to enrollment) monotherapy in MRD+ AML. For combination Regimens A-C, a Phase 1b Dose Escalation Cohort will determine the recommended Phase 2 dose (RP2D) of IMGN632 in that specific combination Regimen, followed by a Phase 2 Dose Expansion Cohort for each combination Regimen to characterize the safety profile further and assess the antileukemia activity of the different combination Regimens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Acute Myeloid Leukemia, AML, Minimal detectable disease, MRD, CD123, Relapsed/refractory, Frontline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
292 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regimen A (Closed to Enrollment)
Arm Type
Experimental
Arm Description
IMGN632, administered intravenously on Day 7 of a 28 day cycle at 0.015 mg/kg, 0.045 mg/kg, or 0.09 mg/kg, in combination with azacitidine, administered subcutaneously or intravenously daily at 75 mg/m2 on Days 1 to 7 of a 28 day cycle. Cycle 1 azacitidine dose in subsequent cohorts may be reduced.
Arm Title
Regimen B (Closed to Enrollment)
Arm Type
Experimental
Arm Description
IMGN632, administered intravenously on Day 7 of a 21 day cycle at 0.015 mg/kg, 0.045 mg/kg, or 0.09 mg/kg, in combination with venetoclax, administered orally daily at 100 mg on Day 1, 200mg on Day 2, and 400 mg on the day 3 up to Day 21 of a 21 day cycle. Alternate schedules with reduced venetoclax administration may be explored.
Arm Title
Regimen C - Frontline (Enrolling) & Relapsed / Refractory (Closed to Enrollment)
Arm Type
Experimental
Arm Description
IMGN632, administered intravenously on Day 7 of a 28 day cycle at 0.015 mg/kg or 0.045 mg/kg, in combination with azacitidine, administered subcutaneously or intravenously daily at 35-75 mg/m2 given for Days 1 to 7 of a 28 day cycle and venetoclax, administered orally daily at 100 mg on Day 1, 200mg on Day 2, and 400 mg on Day 3 up to Day 28 of a 28 day cycle. Alternate schedules with reduced venetoclax administration or reduced azacitidine dose or administration may be explored.
Arm Title
Regimen D (Closed to Enrollment)
Arm Type
Experimental
Arm Description
IMGN632, administered intravenously on Day 1 of a 21 day cycle at 0.045 mg/kg, as a monotherapy for Fit and Unfit MRD+ patients.
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Other Intervention Name(s)
Vidaza, Decitabine
Intervention Description
Commercially available formulation given subcutaneously (SC) or intravenous (IV)
Intervention Type
Drug
Intervention Name(s)
IMGN632
Other Intervention Name(s)
CD123-targeted ADC
Intervention Description
Study formulation given intravenously (IV)
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
Venclexta, Venclyxto
Intervention Description
Commercially available formulation administered orally
Primary Outcome Measure Information:
Title
Safety and Tolerability
Description
Evaluate the safety and tolerability and identify an RP2D of IMGN632 when administered in combination with azacitidine, with venetoclax, and with azacitidine and venetoclax in patients with relapsed or refractory CD123-positive AML through review of Treatment Emergent Adverse Events and abnormal laboratory values that result in a failure to meet the criteria for re-treatment.
Time Frame
approximately 7 months
Title
Preliminary antileukemia activity
Description
Assess preliminary antileukemia activity of IMGN632 when administered as a monotherapy in MRD+ Fit and MRD+ Unfit AML patient populations, and in combination with azacitidine, with venetoclax, and with azacitidine and venetoclax in patients with relapsed or untreated AML as assessed by complete response, complete remission with partial hematologic recovery, complete remission with incomplete platelet recovery, morphologic leukemia-free state, partial response, and duration of remission.
Time Frame
approximately 20 months
Title
Minimal Residual Disease Levels
Description
Assess Minimal Residual Disease Levels using central flow cytometry-based testing.
Time Frame
approximately 18 months
Secondary Outcome Measure Information:
Title
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (Dose Expansion Phase)
Time Frame
Up to approximately 12 months
Title
Study Drug Concentration (Dose Escalation and Expansion)
Time Frame
Up to approximately 12 months
Title
Anti-drug Antibody Concentration (Dose Escalation and Expansion)
Time Frame
Up to approximately 12 months
Title
Minimal Residual Disease Levels (Dose Escalation)
Time Frame
Up to approximately 7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patient Inclusion Criteria Patient must be ≥ 18 years of age. Patients must have confirmed diagnosis of AML (excluding acute promyelocytic leukemia) based on World Health Organization classification (Arber 2016). Disease characteristics and allowable prior therapy: Patients must be evaluated for any available standard of care therapies (including induction, consolidation chemotherapy and/or transplant) and, in the opinion of the treating physician, be deemed appropriate for this experimental therapy. Treatment-naïve (untreated) patients will be allowed in the Expansion Phase for Regimen C (Triplet) (IMGN632 + azacitidine + venetoclax). No prior treatments with hypomethylating agents (HMAs) for MDS are allowed. Patients must have CD123-positive AML as confirmed by local flow cytometry (or immunohistochemistry [IHC]). Patients may have received prior CD123-targeted therapies, except IMGN632, as long as CD123 remains detectable during screening. Relapsed or refractory CD123-positive AML patients will be allowed to enroll in the Escalation Phase of Regimens A, B, and C (Triplet) (IMGN632 + azacitidine, venetoclax, or azacitidine + venetoclax, respectively) and relapsed CD123-positive AML patients will be allowed to enroll the Expansion Phase of Regimens A-C. Note: Patients may also have received up to 2 prior lines of therapy, eg, frontline treatment (induction, consolidation [including transplant], and maintenance) and 1 salvage regimen. Patients enrolling in Regimen D must be in CR (CR/CRh/CRp/CRi) and be MRD+ at the time of screening, confirmed by central laboratory testing. Patients may have no more than 2 prior lines of therapy (which may include stem cell transplant), ie, frontline or first salvage. Note: Fit patients who received intensive treatment (eg 3+7, HiDAC) are eligible for Regimen D Cohort D1. Unfit patients who received non-intensive treatment (eg, HMA, low dose cytarabine) are eligible for Regimen D Cohort D2. Previous treatment-related toxicities must have resolved to Grade 1 or baseline (excluding alopecia). For patients enrolling in Regimens A-D, total WBC count must < 25 × 10^9 cells/L. Hydroxyurea may be used to control blood counts before Cycle 1 Day 1, at the discretion of the treating physician, according to institutional practice. During the Escalation Phase in Regimens A-C, hydroxyurea may also be used during Cycle 1. Liver enzymes (AST and ALT) ≤ 3 × the upper limit of normal (ULN). Total bilirubin ≤ 1.5 × the ULN; patients with Gilbert syndrome must have total bilirubin < 3.0 × ULN with direct bilirubin < 1.0 × ULN at the time of enrollment. An estimated glomerular filtration rate (eGFR) of > 30 mL/min/1.73 m2 or creatinine clearance of > 30 mL/min. Left ventricular ejection fraction (LVEF) ≥ 45% for patients enrolling in Regimens A-D based on locally available assessment, eg, echocardiogram or other modality. Patients with prior autologous or allogeneic bone marrow transplant are eligible. Patients with an allogeneic transplant must meet the following conditions: The transplant must have been performed more than 120 days before the date of dosing on this study, the patient must not have active ≥ Grade 2 graft versus host disease (GvHD), or extensive chronic GvHD of any severity, and must be off all immunosuppression for at least 2 weeks prior to first dose of IMGN632. Voluntary written informed consent before performance of any study-related procedure not part of normal medical care. Women of childbearing potential (WCBP), defined as sexually mature women who have not undergone surgical sterilization or who have not been naturally postmenopausal for at least 12 consecutive months (ie, who have had menses any time in the preceding 12 consecutive months), must agree to use acceptable contraceptive methods while on study drug and for at least 7 months after the last dose of IMGN632. WCBP must have a negative pregnancy test within 3 days before the first dose of study drug. Male patients who are able to father children must agree to use acceptable methods of contraception throughout the study and for at least 4 months after the last dose of study drug(s). Patients with prior malignancy are eligible; however, the patient's malignancy must be well-controlled or stable and have completed all systemic chemotherapy and radiotherapy for the prior malignancy at least 6 months before enrollment, and all treatment-related toxicities must have resolved to ≤ Grade 1 (excluding alopecia). Note: patients with prostate cancer or breast cancer on adjuvant hormonal therapy are eligible and may or may not be on long-term maintenance treatment that is unlikely to interfere with study therapy. Note: patients with tumors with a negligible risk for metastasis or death (eg, adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible. Patients in expansion Cohorts C1 and C2 must be considered ineligible for intensive induction therapy defined by the following: ≥ 75 years of age OR < 75 years of age with at least one of the following co-morbidities documented within 28 days of Cycle 1 Day 1: ECOG performance status of 2 or 3 History of congestive heart failure requirement treatment or ejection fraction ≤ 50% or chronic stable angina Diffusing capacity of the lung for carbon monoxide ≤ 65% or forced expiratory volume in 1 second ≤ 65% Creatinine clearance ≥ 30 mL/min to < 45 mL/min Moderate hepatic impairment with total bilirubin > 1.5 to ≤ 3.0 × ULN Patients in Cohort C1 and C2 must have an ECOG performance status of 0 to 2 for those ≥ 75 years of age OR 0 to 3 for < 75 years of age. Patient Exclusion Criteria Patients who have received any anticancer therapy, including investigational agents, within 14 days (or within 28 days for checkpoint inhibitors) before drug administration on this study (hydroxyurea is allowed before beginning study treatment). Patients must have recovered to baseline from all acute toxicity from this prior therapy. Patients who have been previously treated with IMGN632. Patients with myeloproliferative neoplasm-related secondary AML are excluded from the Dose Expansion Phase of the study. Patients with active central nervous system (CNS) AML will be excluded. A lumbar puncture does not need to be performed unless there is clinical suspicion of CNS involvement per investigator judgement. Concurrent therapy for CNS prophylaxis or continuation of therapy for controlled CNS AML is allowed with the approval of the sponsor. Patients with a history of sinusoidal obstruction syndrome/venous occlusive disease of the liver. Myocardial infarction within 6 months before enrollment or New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities before study entry. Clinically relevant active infection including known active hepatitis B or C, HIV infection, or cytomegalovirus or any other known concurrent infectious disease that, in the judgment of the investigator, would make a patient inappropriate for enrollment into this study (testing not required). Patients who have undergone a major surgery within 4 weeks (or longer if not fully recovered) before study enrollment. Serious or poorly controlled medical conditions that could be exacerbated by treatment or that would seriously compromise safety assessment or compliance with the protocol, in the judgment of the investigator. Women who are pregnant or breastfeeding Prior known hypersensitivity reactions to monoclonal antibodies (≥ Grade 3). Prior known hypersensitivity reactions to study drugs and/or any of their excipients. Patients who have a history of allergy to IMGN632 (or any of its excipients), azacitidine, or venetoclax.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ImmunoGen Clinical Trials
Phone
781-895-0600
Email
medicalinformation@immunogen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Zweidler-McKay, MD
Organizational Affiliation
ImmunoGen, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Benjamin Oshrine, MD
Organizational Affiliation
ImmunoGen, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Aribi, MD
Phone
626-218-1133
Email
aaribi@coh.org
Phone
877-467-3411
First Name & Middle Initial & Last Name & Degree
Ahmed Aribi, MD
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronica de Santiago
Phone
877-827-8839
Email
ucstudy@uci.edu
First Name & Middle Initial & Last Name & Degree
Deepa Jeyakumar, MD
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Wagstaff
Phone
813-745-5197
Email
Caroline.Wagstaff@moffitt.org
First Name & Middle Initial & Last Name & Degree
David Sallman, MD
Facility Name
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick McNamara
Phone
312-695-0267
Email
patrick.mcnamara@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Jessica Altman, MD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Liegel, MD
Phone
617-667-9920
Email
jliegel@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Jessica Liegel, MD
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashleigh Burroughs
Phone
617-632-3500
Email
ashleighM_Burroughs@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Daniel DeAngelo, MD
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cancer Answer Line
Phone
800-865-1125
Email
canceranswerline@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Patrick Burke, Dr.
Facility Name
Mayo Clinic Hospital - Rochester St. Mary's Campus
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Kebede Benga, Dr.
Facility Name
Roswell Park Comprehensive Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Li
Phone
716-845-4176
Email
LeukResearch@roswellpark.org
First Name & Middle Initial & Last Name & Degree
Eunice Wang, MD
Facility Name
NewYork-Presbyterian - Weill Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tania J Curcio
Phone
212-746-2571
Email
tjc9003@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Gail Roboz, MD
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Lee
Phone
216-636-9369
Email
LeeL5@ccf.org
First Name & Middle Initial & Last Name & Degree
Anjali Advani, MD
Facility Name
MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joie Alvarez
Phone
713-792-7321
Email
JAlvarez1@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Naval Daver, MD
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cherise Athay
Phone
206-667-4536
Email
cathay@fredhutch.org
First Name & Middle Initial & Last Name & Degree
Roland Walter, MD
Facility Name
Hospices Civils de Lyon, Lyon-Sud Hospital
City
Lyon
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maël Heiblig
Phone
33478862235
Email
mael.heiblig@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Maël Heiblig, Dr.
Facility Name
Institute Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain Garciaz, MD
Phone
0033491223868
Email
garciazs@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Sylvain Garciaz, Dr.
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anasthasia Gama
Phone
+ 33 (0) 4 92 03 10 35
Email
anasthasia.gama@nice.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Lauris Gastaud, MD
Phone
+ 33 (0) 492031221
Email
Lauris.GASTAUD@nice.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Lauris Gastaud, MD
Facility Name
Hôspital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Boissel, D=MD
Phone
+33 142499643
Email
nicolas.boissel@aphp.fr
First Name & Middle Initial & Last Name & Degree
Nicholas Boissel, Dr.
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Recher, MD
Phone
0033 05 82741631
Email
Recher.Christian@iuct-oncopole.fr
First Name & Middle Initial & Last Name & Degree
Christian Recher, Dr.
Facility Name
Hôpital André Mignot
City
Versailles
ZIP/Postal Code
78157
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Rousselot, MD
Phone
0033 01 39638010
Email
phrousselot@ch-versailles.fr
First Name & Middle Initial & Last Name & Degree
Philippe Rousselot, MD
Facility Name
University Hospital Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karolin Hubert
Phone
+49 341 97-20363
Email
karolin.hubert@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Jana Heinrichs-Knopf
Phone
+49 341 97 12634
First Name & Middle Initial & Last Name & Degree
Uwe Platzbecker, MD
First Name & Middle Initial & Last Name & Degree
Sabine Kayser, MD
Facility Name
University Hospital Muenster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Schliemann, MD
Phone
0049 251 83 45363
Email
christoph.schliemann@ukmuenster.de
First Name & Middle Initial & Last Name & Degree
Christopher Schliemann, Dr.
Facility Name
University Hospital of Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayten Sagir
Phone
0731-45927
Email
ayten.sagir@uniklinik-ulm.de
First Name & Middle Initial & Last Name & Degree
Tobias Glöggler
Phone
0731-45746
Email
tobias.gloeggler@uniklinik-ulm.de
First Name & Middle Initial & Last Name & Degree
Silke Kapp-Schwoerer, Dr
First Name & Middle Initial & Last Name & Degree
Frank Rueker, Dr
Facility Name
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Policlinco S. Orsola - Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Curti, MD
Phone
+390512144074
Email
antonio.curti@unibo.it
First Name & Middle Initial & Last Name & Degree
Antonio Curti, MD
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Marconi, MD
Phone
0039 0543 739292
Email
giovanni.marconi@irst.emr.it
First Name & Middle Initial & Last Name & Degree
Giovanni Martinelli, MD
Facility Name
European Institute of Oncology IRCCS
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrico Derenzini, MD
Phone
+39 0257489.538
Email
Enrico.Derenzini@ieo.it
First Name & Middle Initial & Last Name & Degree
Enrico Derenzini, Dr.
Facility Name
Azienda Ospedaliera Universitaria Maggiore Della Carita Novara
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Lunghi, MD
Phone
+39 0321 3733092
Email
monica.lunghi@unipo.it
First Name & Middle Initial & Last Name & Degree
Monica Lunghi, MD
Facility Name
MD Anderson Cancer Center Madrid, Spain
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adolfo de La Fuente, MD
Phone
+34917878600
Ext
2883
Email
afuente@mdanderson.es
First Name & Middle Initial & Last Name & Degree
Adolfo de La Fuente, MD
Facility Name
Hospital Universitario y Politécnico de La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Pellicer
Phone
0034961244864
Email
pellicer_dav@gva.es
First Name & Middle Initial & Last Name & Degree
Pau Montesinos, MD
Facility Name
Oxford University Hospital - Churchill Hospital
City
Headington
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paresh Vyas, MD
Phone
0044 01865222443
Email
paresh.vyas@imm.ox.ac.uk
First Name & Middle Initial & Last Name & Degree
Paresh Vyas, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia

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