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A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia

Primary Purpose

Acute Lymphoblastic Leukemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
inotuzumab ozogamicin
FLAG (fludarabine, cytarabine and G-CSF)
HIDAC (high dose cytarabine)
cytarabine and mitoxantrone
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia

Eligibility Criteria

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

Inclusion Criteria:

  • CD22 expression
  • Adequate liver and renal functions

Exclusion Criteria:

  • Isolated extramedullary disease
  • Active Central Nervous System [CNS] disease

Sites / Locations

  • Investigational Drug Services - UC San Diego Moores Cancer Center
  • UC San Diego Medical Center - La Jolla
  • UC San Diego Moores Cancer Center
  • Children's Center for Cancer and Blood Diseases, Childrens Hospital Los Angeles
  • Keck Hospital of USC
  • LAC+USC Medical Center
  • USC Norris Comprehensive Cancer Center
  • USC/Norris Comprehensive Cancer Center / Investigational Drug Services
  • USC/Norris Comprehensive Cancer Center
  • UCLA Drug Information/Investigation Drug
  • UCLA Hematology/Oncology Clinic
  • UCLA Ronald Reagan Medical Center
  • UCLA Rrmc
  • UC Irvine Medical Center
  • Children's Hospital of Orange County
  • UC Irvine Medical Center
  • Freidenrich Center for Translational Research (CTRU), Stanford University
  • UC San Diego Medical Center - Hillcrest
  • Martha Hamilton, Investigational Drug Services, Dept of Pharmacy
  • Stanford Cancer Institute
  • Stanford University Hospital and Clinics
  • University of Colorado Cancer Center
  • University of Colorado Hospital, Cancer Center Infusion Center
  • University of Colorado Hospital
  • Yale-New Haven Hospital & Smilow Cancer Center
  • Miami Children's Hospital
  • MD Anderson Cancer Center Orlando - 5th Floor Investigational Pharmacy
  • MD Anderson Cancer Center Orlando
  • Orlando Heart Health Institute
  • Orlando Regional Medical Center
  • Emory University Hospital
  • Investigational Drug Service, Emory University Clinic
  • The Emory Clinic
  • Winship Cancer Institute, Emory University
  • Blood and Marrow Transplant Group of Georgia
  • Northside Hospital
  • Georgia Regents Medical Center Pharmacy, Georgia Regents University Cancer Center
  • Georgia Regents University
  • Northwestern Medical Faculty Foundation
  • Northwestern Medicine Developmental Therapeutics Institute
  • Northwestern Memorial Hospital
  • The University of Chicago
  • University of Chicago Medical Center, Dept. of Pharmacy
  • University of Iowa Hospitals and Clinics
  • University of Kansas Hospital
  • University of Kansas Cancer Center
  • Norton Cancer Institute
  • Norton Cancer Institute, Suburban
  • University of Maryland
  • Oncology Investigational Drug Service
  • The Sidney Kimmel Comprehensive Cancer Center
  • Massachusetts General Hospital (MGH)
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
  • University of Michigan Health System-
  • Karmanos Cancer Institute
  • Karmanos Cancer Institute Weisberg Cancer Treatment Center
  • Hackensack University Medical Center
  • John Theurer Cancer Center at Hackensack University Medical Center
  • Rutgers Cancer Institute of New Jersey
  • University of New Mexico Comprehensive Cancer Center
  • UNM Cancer Center
  • Monter Cancer Center
  • North Shore University Hospital
  • New York Presbyterian Hospital-Weill Cornell Medical College
  • NewYork-Presbyterian Hospital
  • Weill Cornell Medical College - New York-Presbyterian Hospital
  • University of Rochester Medical Center
  • Stony Brook University Medical Center
  • Stony Brook University Medical Center, The Cancer Center
  • Division of Hematology/Oncology, Stony Brook University Hospital
  • Stony Brook University Medical Center
  • UNC Cancer Hospital Infusion Pharmacy
  • UNC Hospitals - The University of North Carolina at Chapel Hill
  • Wake Forest Baptist Health
  • University of Cincinnati Medical Center
  • University Hospitals of Cleveland
  • Cleveland Clinic Foundation
  • OU Medical Center Presbyterian Tower
  • Stephenson Cancer Center
  • IDS-investigational drug pharmacy Penn State Milton S. Hershey Medical Center
  • Penn State Milton S. Hershey Medical Center,
  • Hollings Cancer Center
  • MUSC Hospital
  • Parkland Health and Hospital System
  • Baylor Charles A. Sammons Cancer Center
  • Baylor University Medical Center
  • University of Texas Southwestern Universtiy Hospital - William P Clements Jr.
  • UT Southwestern Medical Center at Dallas
  • UT Southwestern University Hospital- Zale Lipshy
  • The University of Texas MD Anderson Cancer Center
  • LDS Hospital
  • Seattle Cancer Care Alliance
  • University of Washington
  • West Virginia University Hospitals Pharmaceutical Services
  • West Virginia University Hospitals
  • Sanatorio Allende
  • Royal Adelaide Hospital
  • Eastern Clinical Research Unit, Box Hill Hospital
  • Princess Margaret Cancer Centre
  • Guangdong General Hospital
  • Henan Cancer Hostipal
  • The first hospital of jilin university
  • Beijing Chao-yang Hospital
  • Peking University People's Hospital
  • The 307th Hospital of PLA
  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences,
  • Interni Hematologicka a Onkologicka Klinika
  • Fakultni Nemocnice Hradec Kralove
  • Fakultni nemocnice Kralovske Vinohrady
  • HUS-Kuvantaminen
  • HYKS/Hematologian klinikka
  • CHU de Dijon-Hopital d'Enfants-Service d'hematologie Clinique
  • C.H.U. de Grenoble, Hopital Albert Michallon
  • Hopital Universitaire Andre Mignot
  • CHU Dupuytren
  • Institut Paoli-Calmettes
  • Hôpital Saint-Louis
  • Centre Hospitalier Lyon Sud
  • Institut de Cancérologie Lucien Neuwirth
  • Iuct - Oncopole
  • CHU Brabois- Service d'hematologie
  • Zentralapotheke des Universitaetsklinikums Muenster
  • Klinikum der Goethe Universitaet
  • Universitaetsklinikum Heidelberg
  • Universitätsklinikum Köln, Klinik I für Innere Medizin
  • Klinikum Rechts der Isar der TU München
  • Institut fuer klinische Radiologie
  • Universitaetsklinikum Muenster
  • Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet;
  • Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum II. Belgyogyaszati Klinika
  • Azienda Ospedaliera Brotzu CTMO P.O. Businco
  • Farmacia
  • U.O. Radiodiagnostica
  • IRST-Ematologia
  • Istituto di Ematologia Seragnoli
  • A.O.U. Vittorio Emanuele di Catania-Ospedale Ferrarotto
  • Radiology (Radiology Only)
  • U.O. di Ematologia Dip. Medicine Specialistiche A.O.U. Arcispedale Sant'Anna
  • Clinica Ematologica
  • Pharmacy
  • Radiology Department (Radiology ONLY)
  • Radiology Department
  • U.O. Ematologia 1
  • S.C. Pharmacy
  • S.C. Radiology
  • SC Ematologia
  • A.O. San Gerardo - Farmacia
  • A.O. San Gerardo di Monza
  • AORN "A. Cardarelli"
  • RAdiology Department (RAdiology only)
  • Clinica Ematologica
  • Radiologist Department
  • Servizio di Farmacia
  • U.O. Ematologia, Ospedale S. Maria delle Croci
  • Clinica Ematologica
  • Radiology (Radiology Only)
  • Nagoya Daini Red Cross Hospital
  • The Hospital of Hyogo College of Medicine
  • Tohoku University Hospital
  • Osaka City University Hospital
  • National Cancer Center Hospital
  • Akita University Hospital
  • National Hospital Organization Kyushu Cancer Center
  • Tokai University Hospital
  • Chonnam National University, Hwasun Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Erasmus Medical Center
  • Erasmus Medical Center
  • Klinika Hematologii i Transplantologii
  • Oddzial Hematologii, Klinika Hematologii, Regionalny Osrodek Onkologiczny Wojewodzki Szpital
  • Instytut Hematologii i Transfuzjologii, Klinika Hematologii
  • Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
  • National University Hospital/National University Cancer Institute Singapore (NCIS)
  • Singapore General Hospital
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Universitario de Salamanca
  • Hospital Vall d'Hebron
  • Hospital Son Llatzer
  • Hospital de la Santa Creu i Sant Pau(Nuevo Hospital)
  • Hospital General Universitario Gregorio Maranon
  • Hospital Ramon y Cajal
  • Hospital Universitario 12 de Octubre
  • Hospital General Universitario Jose Maria Morales Meseguer
  • Hospital Universitario Virgen del Rocio
  • Hospital Clinico Universitario de Valencia
  • Universitetssjukhus Lund, Hematologkliniken
  • Hematology Center
  • Chang Gung Medical Foundation, Kaohsiung Branch
  • National Taiwan University Hospital
  • Southampton General Hospital
  • Bristol Haematology and Oncology Centre
  • Castle Hill Hospital
  • Department of Academic Oncology
  • The Christie NHS Foundation Trust
  • Nottingham University Hospitals NHS Trust
  • Churchill Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC)
CR was the disappearance of leukemia indicated by less than (<) 5 percent (%) marrow blasts & absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) greater than or equal to (≥)1000 per microliter (/μL) & platelets ≥100,000/μL. C1 extramedullary disease status (i.e. complete disappearance of measurable & non-measurable extramedullary disease with the following exceptions: for participants with at least 1 measurable lesion, all nodal masses greater than (>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) at baseline must have regressed to less than or equal to (≤) 1.5 cm in GTD; all nodal masses ≥1 cm & ≤1.5 cm in GTD at baseline must have regressed to <1 cm GTD or reduced by 75% in sum of products of greatest diameters, no new lesions, spleen & other previously enlarged organs must have regressed in size & must not be palpable) was required. CRi was defined as CR except ANC <1000/μL &/or platelets <100,000/μL.
Overall Survival (OS)
OS was defined as the time from randomization to date of death due to any cause. Participants last known to be alive were censored at date of last contact.

Secondary Outcome Measures

Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment)
DoR was defined as time from date of first response in responders (CR/CRi per Investigator assessment) to date of PFS event (i.e. death, progressive disease [objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status] or starting new induction therapy or post-therapy stem cell transplant [SCT] without achieving CR/CRi). Responders without PFS events were censored at the last valid disease assessment including follow-up.
Progression-Free Survival (PFS)
PFS was defined as time from date of randomization to earliest date of the following events: death, progressive disease (objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status) and starting new induction therapy or post-therapy SCT without achieving CR/CRi. Participants without a PFS event at time of analysis were censored at the last valid disease assessment. In addition, participants with documentation of an event after an unacceptably long interval (>28 weeks if there was post-baseline disease assessment, or >12 weeks if there was no post-baseline assessment) since the previous disease assessment were censored at the time of the previous assessment (date of randomization if no post-baseline assessment). Post-study treatment follow-up disease assessments was included. Kaplan-Meier method used and 2-sided 95% confidence interval (CI) calculated based on the Brookmeyer and Crowley method.
Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT)
HSCT rate was defined as the percentage of participants who underwent SCT following treatment with inotuzumab ozogamicin or Investigator's choice of chemotherapy.
Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment)
MRD analysis was performed at least once in participants with prior assessment of CR or CRi. Bone marrow aspirates, collected at screening and during the study, were sent to the central laboratory and analyzed using multiparametric flow cytometry. The antibody combinations were designed to maximize discrimination between normal and abnormal cells of B-cell lineage and similar maturational stage and included antibodies detecting cluster of differentiation (CD) 9, CD10, CD13, CD19, CD20, CD33, CD34, CD38, CD45, CD58, CD66c, and CD123. A peripheral blood sample was provided if a participant had an inadequate bone marrow aspirate at screening. MRD negativity was considered to have been achieved if the lowest value of MRD from the first date of CR/CRi to EoT was <1 × 10^-4 blasts/nucleated cells.
Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment)
Karyotyping was required locally, at screening and at least once during the study in participants who had abnormal cytogenetics at baseline and who achieved CR/CRi. Data presented below are for participants who achieved CR/CRi per EAC and had abnormal karyotype at screening.
Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) and Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing
Blood samples were collected and analyzed for inotuzumab ozogamicin serum concentrations using a validated high performance liquid chromatography with tandem mass spectrometry (HPLC/MS/MS) method with a lower limit of quantification of 1.0 nanograms per milliliter (ng/mL). Cmax was the maximum observed concentration occurring between 0-8 hours post-dose. Ctrough was the concentration prior to subsequent dose (pre-dose) occurring after 8 hours. n = number of observations (non-missing concentrations).
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) Score
This questionnaire comprised 30 questions within which are 9 multi-item scales & 6 single-item measures. There are 5 functional scales; physical, role, cognitive, emotional & social, 3 symptom scales; fatigue, pain, & nausea & vomiting, & a global health status/quality of life (QoL) scale. There are 5 single item measures assessing additional symptoms commonly reported by cancer patients (loss of appetite, insomnia, constipation, diarrhea, & dyspnea) & a single item concerning perceived financial impact of the disease. Most questions used a 4 point scale (1='not at all' to 4='very much'); 2 questions used a 7-point scale (1='very poor' to 7='excellent'). Scores were averaged & transformed to a scale ranging from 0 to 100; a higher score indicates a better level of functioning or greater degree of symptoms.
Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score
The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting "no problems", "some problems", and "extreme problems". The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).
Change From Baseline in EQ-5D VAS
The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting "no problems", "some problems", and "extreme problems". The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
Percentage of Participants With Veno-Occlusive Liver Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Following Post Study HSCT
VOD/SOS was defined as the occurrence of 2 out of the following 3 clinical criteria: 1) total serum bilirubin level >34 micromoles per liter (μmol/L) (>2.0 milligrams per deciliter [mg/dL]), 2) an increase in liver size from baseline or development of right upper quadrant pain of liver origin and 3) sudden weight gain >2.5% (eg, within a 72 hour period) because of fluid accumulation in the weeks following infusion of study drug or chemotherapy, or HSCT conditioning/preparative therapy, or development of ascites not present at baseline following such exposures AND the absence of other explanations for these signs and symptoms, OR development of bilirubin elevation, weight gain, or hepatomegaly plus histologic abnormalities on liver biopsy demonstrating hepatocyte necrosis in zone 3 of the liver acinus, sinusoidal fibrosis, and centrilobular hemorrhage, with or without fibrosis of the terminal hepatic venules.

Full Information

First Posted
March 26, 2012
Last Updated
December 20, 2018
Sponsor
Pfizer
Collaborators
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01564784
Brief Title
A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia
Official Title
AN OPEN-LABEL, RANDOMIZED PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN COMPARED TO A DEFINED INVESTIGATOR'S CHOICE IN ADULT PATIENTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 2, 2012 (Actual)
Primary Completion Date
March 8, 2016 (Actual)
Study Completion Date
January 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
UCB Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
326 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Title
Arm B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
inotuzumab ozogamicin
Intervention Description
Dose: inotuzumab ozogamicin 0.8-0.5 mg/m^2 IV, weekly, 3 times per cycle Cycle length: 21-28 days Total number of cycles: 6
Intervention Type
Drug
Intervention Name(s)
FLAG (fludarabine, cytarabine and G-CSF)
Intervention Description
Dose: cytarabine 2.0 g/m^2/day IV days 1-6 fludarabine30 mg/m^2/day IV days 2-6 Cycle length: 28 days Total number of cycles: 4
Intervention Type
Drug
Intervention Name(s)
HIDAC (high dose cytarabine)
Intervention Description
cytarabine 3 g/m^2 IV every 12 hours for up to 12 times
Intervention Type
Drug
Intervention Name(s)
cytarabine and mitoxantrone
Intervention Description
mitoxantrone 12 mg/m^2 IV days 1-3 cytarabine 200 mg/m^2/day IV over 7 days cycle length: 15-20 days Total number of cycles: 4
Primary Outcome Measure Information:
Title
Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC)
Description
CR was the disappearance of leukemia indicated by less than (<) 5 percent (%) marrow blasts & absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) greater than or equal to (≥)1000 per microliter (/μL) & platelets ≥100,000/μL. C1 extramedullary disease status (i.e. complete disappearance of measurable & non-measurable extramedullary disease with the following exceptions: for participants with at least 1 measurable lesion, all nodal masses greater than (>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) at baseline must have regressed to less than or equal to (≤) 1.5 cm in GTD; all nodal masses ≥1 cm & ≤1.5 cm in GTD at baseline must have regressed to <1 cm GTD or reduced by 75% in sum of products of greatest diameters, no new lesions, spleen & other previously enlarged organs must have regressed in size & must not be palpable) was required. CRi was defined as CR except ANC <1000/μL &/or platelets <100,000/μL.
Time Frame
Screening, Day 16 to 28 of Cycles 1, 2 and 3, then every 1 to 2 cycles (or as clinically indicated) up to approximately 4 weeks (end of treatment [EoT]) from the last dose
Title
Overall Survival (OS)
Description
OS was defined as the time from randomization to date of death due to any cause. Participants last known to be alive were censored at date of last contact.
Time Frame
Up to 5 years after randomization or 2 years from randomization of the last participant, whichever occurs first.
Secondary Outcome Measure Information:
Title
Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment)
Description
DoR was defined as time from date of first response in responders (CR/CRi per Investigator assessment) to date of PFS event (i.e. death, progressive disease [objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status] or starting new induction therapy or post-therapy stem cell transplant [SCT] without achieving CR/CRi). Responders without PFS events were censored at the last valid disease assessment including follow-up.
Time Frame
Up to 2 years from randomization
Title
Progression-Free Survival (PFS)
Description
PFS was defined as time from date of randomization to earliest date of the following events: death, progressive disease (objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status) and starting new induction therapy or post-therapy SCT without achieving CR/CRi. Participants without a PFS event at time of analysis were censored at the last valid disease assessment. In addition, participants with documentation of an event after an unacceptably long interval (>28 weeks if there was post-baseline disease assessment, or >12 weeks if there was no post-baseline assessment) since the previous disease assessment were censored at the time of the previous assessment (date of randomization if no post-baseline assessment). Post-study treatment follow-up disease assessments was included. Kaplan-Meier method used and 2-sided 95% confidence interval (CI) calculated based on the Brookmeyer and Crowley method.
Time Frame
Up to 2 years from randomization
Title
Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT)
Description
HSCT rate was defined as the percentage of participants who underwent SCT following treatment with inotuzumab ozogamicin or Investigator's choice of chemotherapy.
Time Frame
Up to 19 weeks from last dose
Title
Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment)
Description
MRD analysis was performed at least once in participants with prior assessment of CR or CRi. Bone marrow aspirates, collected at screening and during the study, were sent to the central laboratory and analyzed using multiparametric flow cytometry. The antibody combinations were designed to maximize discrimination between normal and abnormal cells of B-cell lineage and similar maturational stage and included antibodies detecting cluster of differentiation (CD) 9, CD10, CD13, CD19, CD20, CD33, CD34, CD38, CD45, CD58, CD66c, and CD123. A peripheral blood sample was provided if a participant had an inadequate bone marrow aspirate at screening. MRD negativity was considered to have been achieved if the lowest value of MRD from the first date of CR/CRi to EoT was <1 × 10^-4 blasts/nucleated cells.
Time Frame
Up to approximately 4 weeks (EoT) from last dose of study drug
Title
Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment)
Description
Karyotyping was required locally, at screening and at least once during the study in participants who had abnormal cytogenetics at baseline and who achieved CR/CRi. Data presented below are for participants who achieved CR/CRi per EAC and had abnormal karyotype at screening.
Time Frame
Up to approximately 4 weeks (EoT) from last dose of study drug
Title
Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) and Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing
Description
Blood samples were collected and analyzed for inotuzumab ozogamicin serum concentrations using a validated high performance liquid chromatography with tandem mass spectrometry (HPLC/MS/MS) method with a lower limit of quantification of 1.0 nanograms per milliliter (ng/mL). Cmax was the maximum observed concentration occurring between 0-8 hours post-dose. Ctrough was the concentration prior to subsequent dose (pre-dose) occurring after 8 hours. n = number of observations (non-missing concentrations).
Time Frame
Days 1, 4, 8, and 15 of Cycle 1, Days 1 and 8 of Cycle 2 and Day 1 of Cycle 4
Title
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) Score
Description
This questionnaire comprised 30 questions within which are 9 multi-item scales & 6 single-item measures. There are 5 functional scales; physical, role, cognitive, emotional & social, 3 symptom scales; fatigue, pain, & nausea & vomiting, & a global health status/quality of life (QoL) scale. There are 5 single item measures assessing additional symptoms commonly reported by cancer patients (loss of appetite, insomnia, constipation, diarrhea, & dyspnea) & a single item concerning perceived financial impact of the disease. Most questions used a 4 point scale (1='not at all' to 4='very much'); 2 questions used a 7-point scale (1='very poor' to 7='excellent'). Scores were averaged & transformed to a scale ranging from 0 to 100; a higher score indicates a better level of functioning or greater degree of symptoms.
Time Frame
Day 1 of each cycle prior to dosing and EoT
Title
Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score
Description
The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting "no problems", "some problems", and "extreme problems". The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).
Time Frame
Day 1 of each cycle prior to dosing and EoT
Title
Change From Baseline in EQ-5D VAS
Description
The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting "no problems", "some problems", and "extreme problems". The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
Time Frame
Day 1 of each cycle prior to dosing and EoT
Title
Percentage of Participants With Veno-Occlusive Liver Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Following Post Study HSCT
Description
VOD/SOS was defined as the occurrence of 2 out of the following 3 clinical criteria: 1) total serum bilirubin level >34 micromoles per liter (μmol/L) (>2.0 milligrams per deciliter [mg/dL]), 2) an increase in liver size from baseline or development of right upper quadrant pain of liver origin and 3) sudden weight gain >2.5% (eg, within a 72 hour period) because of fluid accumulation in the weeks following infusion of study drug or chemotherapy, or HSCT conditioning/preparative therapy, or development of ascites not present at baseline following such exposures AND the absence of other explanations for these signs and symptoms, OR development of bilirubin elevation, weight gain, or hepatomegaly plus histologic abnormalities on liver biopsy demonstrating hepatocyte necrosis in zone 3 of the liver acinus, sinusoidal fibrosis, and centrilobular hemorrhage, with or without fibrosis of the terminal hepatic venules.
Time Frame
Up to 2 years from randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: CD22 expression Adequate liver and renal functions Exclusion Criteria: Isolated extramedullary disease Active Central Nervous System [CNS] disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Drug Services - UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-0845
Country
United States
Facility Name
UC San Diego Medical Center - La Jolla
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0698
Country
United States
Facility Name
Children's Center for Cancer and Blood Diseases, Childrens Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Keck Hospital of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
LAC+USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center / Investigational Drug Services
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA Drug Information/Investigation Drug
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA Hematology/Oncology Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA Ronald Reagan Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA Rrmc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868-3201
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Freidenrich Center for Translational Research (CTRU), Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
UC San Diego Medical Center - Hillcrest
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Martha Hamilton, Investigational Drug Services, Dept of Pharmacy
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Stanford Cancer Institute
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Stanford University Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital, Cancer Center Infusion Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale-New Haven Hospital & Smilow Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
MD Anderson Cancer Center Orlando - 5th Floor Investigational Pharmacy
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
MD Anderson Cancer Center Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Orlando Heart Health Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Orlando Regional Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Investigational Drug Service, Emory University Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Blood and Marrow Transplant Group of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Georgia Regents Medical Center Pharmacy, Georgia Regents University Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Georgia Regents University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Northwestern Medical Faculty Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern Medicine Developmental Therapeutics Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Chicago Medical Center, Dept. of Pharmacy
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Norton Cancer Institute, Suburban
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Oncology Investigational Drug Service
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
The Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Massachusetts General Hospital (MGH)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Health System-
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Karmanos Cancer Institute Weisberg Cancer Treatment Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
University of New Mexico Comprehensive Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-0001
Country
United States
Facility Name
UNM Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Monter Cancer Center
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
New York Presbyterian Hospital-Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
NewYork-Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical College - New York-Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-7007
Country
United States
Facility Name
Stony Brook University Medical Center, The Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-9447
Country
United States
Facility Name
Division of Hematology/Oncology, Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
UNC Cancer Hospital Infusion Pharmacy
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
UNC Hospitals - The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7600
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
OU Medical Center Presbyterian Tower
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
IDS-investigational drug pharmacy Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center,
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
MUSC Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Parkland Health and Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas Southwestern Universtiy Hospital - William P Clements Jr.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
UT Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
UT Southwestern University Hospital- Zale Lipshy
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
West Virginia University Hospitals Pharmaceutical Services
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
West Virginia University Hospitals
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Sanatorio Allende
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Eastern Clinical Research Unit, Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Henan Cancer Hostipal
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
The first hospital of jilin university
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Beijing Chao-yang Hospital
City
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
The 307th Hospital of PLA
City
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences,
City
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
Interni Hematologicka a Onkologicka Klinika
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Fakultni Nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
10034
Country
Czechia
Facility Name
HUS-Kuvantaminen
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
HYKS/Hematologian klinikka
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
CHU de Dijon-Hopital d'Enfants-Service d'hematologie Clinique
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
C.H.U. de Grenoble, Hopital Albert Michallon
City
Grenoble Cedex 09
ZIP/Postal Code
38043
Country
France
Facility Name
Hopital Universitaire Andre Mignot
City
Le Chesnay Cedex
ZIP/Postal Code
78157
Country
France
Facility Name
CHU Dupuytren
City
Limoges Cedex
ZIP/Postal Code
87042
Country
France
Facility Name
Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Institut de Cancérologie Lucien Neuwirth
City
Saint Priest en Jarez Cedex
ZIP/Postal Code
42271
Country
France
Facility Name
Iuct - Oncopole
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
CHU Brabois- Service d'hematologie
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Zentralapotheke des Universitaetsklinikums Muenster
City
Muenster
State/Province
Nordrhein-westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Klinikum der Goethe Universitaet
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum Köln, Klinik I für Innere Medizin
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Klinikum Rechts der Isar der TU München
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Institut fuer klinische Radiologie
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet;
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum II. Belgyogyaszati Klinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Azienda Ospedaliera Brotzu CTMO P.O. Businco
City
Cagliari
State/Province
CA
ZIP/Postal Code
09121
Country
Italy
Facility Name
Farmacia
City
Cagliari
State/Province
CA
ZIP/Postal Code
09121
Country
Italy
Facility Name
U.O. Radiodiagnostica
City
Cagliari
State/Province
CA
ZIP/Postal Code
09121
Country
Italy
Facility Name
IRST-Ematologia
City
Meldola (FC)
State/Province
FC
ZIP/Postal Code
47014
Country
Italy
Facility Name
Istituto di Ematologia Seragnoli
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
A.O.U. Vittorio Emanuele di Catania-Ospedale Ferrarotto
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Radiology (Radiology Only)
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
U.O. di Ematologia Dip. Medicine Specialistiche A.O.U. Arcispedale Sant'Anna
City
Cona, Ferrara
ZIP/Postal Code
44124
Country
Italy
Facility Name
Clinica Ematologica
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Pharmacy
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Radiology Department (Radiology ONLY)
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Radiology Department
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
U.O. Ematologia 1
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
S.C. Pharmacy
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
S.C. Radiology
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
SC Ematologia
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
A.O. San Gerardo - Farmacia
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
A.O. San Gerardo di Monza
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
AORN "A. Cardarelli"
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
RAdiology Department (RAdiology only)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Clinica Ematologica
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Radiologist Department
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Servizio di Farmacia
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
U.O. Ematologia, Ospedale S. Maria delle Croci
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Clinica Ematologica
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Radiology (Radiology Only)
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Nagoya Daini Red Cross Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
4668650
Country
Japan
Facility Name
The Hospital of Hyogo College of Medicine
City
Nishinomiya-shi
State/Province
Hyogo
ZIP/Postal Code
6638501
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka-city
State/Province
Osaka
ZIP/Postal Code
5458586
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
1040045
Country
Japan
Facility Name
Akita University Hospital
City
Akita
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka
ZIP/Postal Code
8111395
Country
Japan
Facility Name
Tokai University Hospital
City
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Chonnam National University, Hwasun Hospital
City
Hwasun-Gun
State/Province
Jeonnam
ZIP/Postal Code
519-763
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135 710
Country
Korea, Republic of
Facility Name
Erasmus Medical Center
City
Rotterdam
State/Province
South Holland
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
State/Province
South Holland
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Klinika Hematologii i Transplantologii
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Oddzial Hematologii, Klinika Hematologii, Regionalny Osrodek Onkologiczny Wojewodzki Szpital
City
Lodz
ZIP/Postal Code
93510
Country
Poland
Facility Name
Instytut Hematologii i Transfuzjologii, Klinika Hematologii
City
Warsaw
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
City
Wroclaw
ZIP/Postal Code
53-439
Country
Poland
Facility Name
National University Hospital/National University Cancer Institute Singapore (NCIS)
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
State/Province
Castille AND LION
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Son Llatzer
City
Palma de Mallorca
State/Province
Mallorca
ZIP/Postal Code
07198
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau(Nuevo Hospital)
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital General Universitario Jose Maria Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Universitetssjukhus Lund, Hematologkliniken
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Hematology Center
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Chang Gung Medical Foundation, Kaohsiung Branch
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Southampton General Hospital
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Department of Academic Oncology
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
35643855
Citation
Stelljes M, Advani AS, DeAngelo DJ, Wang T, Neuhof A, Vandendries E, Kantarjian H, Jabbour E. Time to First Subsequent Salvage Therapy in Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia Treated With Inotuzumab Ozogamicin in the Phase III INO-VATE Trial. Clin Lymphoma Myeloma Leuk. 2022 Sep;22(9):e836-e843. doi: 10.1016/j.clml.2022.04.022. Epub 2022 Apr 27.
Results Reference
derived
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
PubMed Identifier
33602684
Citation
Kantarjian HM, Stock W, Cassaday RD, DeAngelo DJ, Jabbour E, O'Brien SM, Stelljes M, Wang T, Paccagnella ML, Nguyen K, Sleight B, Vandendries E, Neuhof A, Laird AD, Advani AS. Inotuzumab Ozogamicin for Relapsed/Refractory Acute Lymphoblastic Leukemia in the INO-VATE Trial: CD22 Pharmacodynamics, Efficacy, and Safety by Baseline CD22. Clin Cancer Res. 2021 May 15;27(10):2742-2754. doi: 10.1158/1078-0432.CCR-20-2399. Epub 2021 Feb 18.
Results Reference
derived
PubMed Identifier
33231879
Citation
Stock W, Martinelli G, Stelljes M, DeAngelo DJ, Gokbuget N, Advani AS, O'Brien S, Liedtke M, Merchant AA, Cassaday RD, Wang T, Zhang H, Vandendries E, Jabbour E, Marks DI, Kantarjian HM. Efficacy of inotuzumab ozogamicin in patients with Philadelphia chromosome-positive relapsed/refractory acute lymphoblastic leukemia. Cancer. 2021 Mar 15;127(6):905-913. doi: 10.1002/cncr.33321. Epub 2020 Nov 24.
Results Reference
derived
PubMed Identifier
32769965
Citation
DeAngelo DJ, Advani AS, Marks DI, Stelljes M, Liedtke M, Stock W, Gokbuget N, Jabbour E, Merchant A, Wang T, Vandendries E, Neuhof A, Kantarjian H, O'Brien S. Inotuzumab ozogamicin for relapsed/refractory acute lymphoblastic leukemia: outcomes by disease burden. Blood Cancer J. 2020 Aug 7;10(8):81. doi: 10.1038/s41408-020-00345-8.
Results Reference
derived
PubMed Identifier
31790983
Citation
Jabbour E, Gokbuget N, Advani A, Stelljes M, Stock W, Liedtke M, Martinelli G, O'Brien S, Wang T, Laird AD, Vandendries E, Neuhof A, Nguyen K, Dakappagari N, DeAngelo DJ, Kantarjian H. Impact of minimal residual disease status in patients with relapsed/refractory acute lymphoblastic leukemia treated with inotuzumab ozogamicin in the phase III INO-VATE trial. Leuk Res. 2020 Jan;88:106283. doi: 10.1016/j.leukres.2019.106283. Epub 2019 Nov 25.
Results Reference
derived
PubMed Identifier
31655984
Citation
Fujishima N, Uchida T, Onishi Y, Jung CW, Goh YT, Ando K, Wang MC, Ono C, Matsumizu M, Paccagnella ML, Sleight B, Vandendries E, Fujii Y, Hino M. Inotuzumab ozogamicin versus standard of care in Asian patients with relapsed/refractory acute lymphoblastic leukemia. Int J Hematol. 2019 Dec;110(6):709-722. doi: 10.1007/s12185-019-02749-0. Epub 2019 Nov 13.
Results Reference
derived
PubMed Identifier
30920645
Citation
Kantarjian HM, DeAngelo DJ, Stelljes M, Liedtke M, Stock W, Gokbuget N, O'Brien SM, Jabbour E, Wang T, Liang White J, Sleight B, Vandendries E, Advani AS. Inotuzumab ozogamicin versus standard of care in relapsed or refractory acute lymphoblastic leukemia: Final report and long-term survival follow-up from the randomized, phase 3 INO-VATE study. Cancer. 2019 Jul 15;125(14):2474-2487. doi: 10.1002/cncr.32116. Epub 2019 Mar 28.
Results Reference
derived
PubMed Identifier
29381191
Citation
Jabbour EJ, DeAngelo DJ, Stelljes M, Stock W, Liedtke M, Gokbuget N, O'Brien S, Wang T, Paccagnella ML, Sleight B, Vandendries E, Advani AS, Kantarjian HM. Efficacy and safety analysis by age cohort of inotuzumab ozogamicin in patients with relapsed or refractory acute lymphoblastic leukemia enrolled in INO-VATE. Cancer. 2018 Apr 15;124(8):1722-1732. doi: 10.1002/cncr.31249. Epub 2018 Jan 30.
Results Reference
derived
PubMed Identifier
29330398
Citation
Kebriaei P, Cutler C, de Lima M, Giralt S, Lee SJ, Marks D, Merchant A, Stock W, van Besien K, Stelljes M. Management of important adverse events associated with inotuzumab ozogamicin: expert panel review. Bone Marrow Transplant. 2018 Apr;53(4):449-456. doi: 10.1038/s41409-017-0019-y. Epub 2018 Jan 12.
Results Reference
derived
PubMed Identifier
28687420
Citation
Kantarjian HM, DeAngelo DJ, Advani AS, Stelljes M, Kebriaei P, Cassaday RD, Merchant AA, Fujishima N, Uchida T, Calbacho M, Ejduk AA, O'Brien SM, Jabbour EJ, Zhang H, Sleight BJ, Vandendries ER, Marks DI. Hepatic adverse event profile of inotuzumab ozogamicin in adult patients with relapsed or refractory acute lymphoblastic leukaemia: results from the open-label, randomised, phase 3 INO-VATE study. Lancet Haematol. 2017 Aug;4(8):e387-e398. doi: 10.1016/S2352-3026(17)30103-5. Epub 2017 Jul 4.
Results Reference
derived
PubMed Identifier
27292104
Citation
Kantarjian HM, DeAngelo DJ, Stelljes M, Martinelli G, Liedtke M, Stock W, Gokbuget N, O'Brien S, Wang K, Wang T, Paccagnella ML, Sleight B, Vandendries E, Advani AS. Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia. N Engl J Med. 2016 Aug 25;375(8):740-53. doi: 10.1056/NEJMoa1509277. Epub 2016 Jun 12.
Results Reference
derived

Learn more about this trial

A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia

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