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

December 20, 2018 updated by: Pfizer

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

326

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, 5000
        • Sanatorio Allende
  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Eastern Clinical Research Unit, Box Hill Hospital
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
  • China
      • Beijing, China, 100044
        • Peking University People's Hospital
      • Beijing, China, 100020
        • Beijing Chao-Yang Hospital
      • Beijing, China, 100071
        • The 307th Hospital of PLA
      • Tianjin, China, 300020
        • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences,
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong General Hospital
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hostipal
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
  • Czechia
      • Brno, Czechia, 62500
        • Interni hematologicka a onkologicka klinika
      • Hradec Kralove, Czechia, 50005
        • Fakultni nemocnice Hradec Kralove
      • Praha 10, Czechia, 10034
        • Fakultni nemocnice Kralovske Vinohrady
  • Finland
      • Helsinki, Finland, 00290
        • HUS-Kuvantaminen
      • Helsinki, Finland, 00290
        • HYKS/Hematologian klinikka
  • France
      • Dijon, France, 21000
        • CHU de Dijon-Hopital d'Enfants-Service d'hematologie Clinique
      • Grenoble Cedex 09, France, 38043
        • C.H.U. de Grenoble, Hopital Albert Michallon
      • Le Chesnay Cedex, France, 78157
        • Hopital Universitaire Andre Mignot
      • Limoges Cedex, France, 87042
        • CHU Dupuytren
      • Marseille, France, 13009
        • Institut Paoli-Calmettes
      • Paris Cedex 10, France, 75475
        • Hôpital Saint-Louis
      • Pierre Benite Cedex, France, 69495
        • Centre Hospitalier Lyon Sud
      • Saint Priest en Jarez Cedex, France, 42271
        • Institut de Cancérologie Lucien Neuwirth
      • Toulouse Cedex 9, France, 31059
        • IUCT - Oncopole
      • Vandoeuvre-les-Nancy, France, 54511
        • CHU Brabois- Service d'hematologie
  • Germany
      • Frankfurt, Germany, 60590
        • Klinikum der Goethe Universitaet
      • Heidelberg, Germany, 69120
        • Universitaetsklinikum Heidelberg
      • Köln, Germany, 50937
        • Universitatsklinikum Koln, Klinik I fur Innere Medizin
      • Muenchen, Germany, 81675
        • Klinikum rechts der Isar der TU München
      • Muenster, Germany, 48149
        • Universitaetsklinikum Muenster
      • Muenster, Germany, 48149
        • Institut fuer klinische Radiologie
    • Nordrhein-westfalen
      • Muenster, Nordrhein-westfalen, Germany, 48149
        • Zentralapotheke des Universitaetsklinikums Muenster
  • Hungary
      • Budapest, Hungary, 1097
        • Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet;
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum II. Belgyogyaszati Klinika
  • Italy
      • Bologna, Italy, 40138
        • Istituto di Ematologia Seragnoli
      • Catania, Italy, 95124
        • A.O.U. Vittorio Emanuele di Catania-Ospedale Ferrarotto
      • Catania, Italy, 95124
        • Radiology (Radiology Only)
      • Cona, Ferrara, Italy, 44124
        • U.O. di Ematologia Dip. Medicine Specialistiche A.O.U. Arcispedale Sant'Anna
      • Genova, Italy, 16132
        • Clinica Ematologica
      • Genova, Italy, 16132
        • Pharmacy
      • Genova, Italy, 16132
        • RAdiology Department (RAdiology only)
      • Genova, Italy, 16132
        • Radiology Department
      • Genova, Italy, 16132
        • U.O. Ematologia 1
      • Milano, Italy, 20162
        • S.C. Pharmacy
      • Milano, Italy, 20162
        • S.C. Radiology
      • Milano, Italy, 20162
        • SC Ematologia
      • Monza, Italy, 20900
        • A.O. San Gerardo di Monza
      • Monza, Italy, 20900
        • A.O. San Gerardo - Farmacia
      • Napoli, Italy, 80131
        • AORN "A. Cardarelli"
      • Napoli, Italy, 80131
        • RAdiology Department (RAdiology only)
      • Pavia, Italy, 27100
        • Clinica Ematologica
      • Ravenna, Italy, 48121
        • Radiologist Department
      • Ravenna, Italy, 48121
        • Servizio di Farmacia
      • Ravenna, Italy, 48121
        • U.O. Ematologia, Ospedale S. Maria delle Croci
      • Udine, Italy, 33100
        • Clinica Ematologica
      • Udine, Italy, 33100
        • Radiology (Radiology Only)
    • CA
      • Cagliari, CA, Italy, 09121
        • Azienda Ospedaliera Brotzu CTMO P.O. Businco
      • Cagliari, CA, Italy, 09121
        • Farmacia
      • Cagliari, CA, Italy, 09121
        • U.O. Radiodiagnostica
    • FC
      • Meldola (FC), FC, Italy, 47014
        • IRST-Ematologia
  • Japan
      • Akita, Japan, 010-8543
        • Akita University Hospital
      • Fukuoka, Japan, 8111395
        • National Hospital Organization Kyushu Cancer Center
      • Kanagawa, Japan, 259-1193
        • Tokai University Hospital
    • Aichi
      • Nagoya, Aichi, Japan, 4668650
        • Nagoya Daini Red Cross Hospital
    • Hyogo
      • Nishinomiya-shi, Hyogo, Japan, 6638501
        • The Hospital of Hyogo College of Medicine
    • Miyagi
      • Sendai, Miyagi, Japan, 9808574
        • Tohoku University Hospital
    • Osaka
      • Osaka-city, Osaka, Japan, 5458586
        • Osaka City University Hospital
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 1040045
        • National Cancer Center Hospital
  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 135 710
        • Samsung Medical Center
    • Jeonnam
      • Hwasun-Gun, Jeonnam, Korea, Republic of, 519-763
        • Chonnam National University, Hwasun Hospital
  • Netherlands
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 CE
        • Erasmus Medical Center
      • Rotterdam, South Holland, Netherlands, 3075 EA
        • Erasmus Medical Center
  • Poland
      • Gdansk, Poland, 80-952
        • Klinika Hematologii i Transplantologii
      • Lodz, Poland, 93510
        • Oddzial Hematologii, Klinika Hematologii, Regionalny Osrodek Onkologiczny Wojewodzki Szpital
      • Warsaw, Poland, 02-776
        • Instytut Hematologii i Transfuzjologii, Klinika Hematologii
      • Wroclaw, Poland, 53-439
        • Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
      • Singapore, Singapore, 119228
        • National University Hospital/National University Cancer Institute Singapore (NCIS)
  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau(Nuevo Hospital)
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
      • Murcia, Spain, 30008
        • Hospital General Universitario Jose Maria Morales Meseguer
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
    • Castille AND LION
      • Salamanca, Castille AND LION, Spain, 37007
        • Hospital Universitario de Salamanca
    • Catalonia
      • Barcelona, Catalonia, Spain, 08035
        • Hospital Vall d'Hebron
    • Mallorca
      • Palma de Mallorca, Mallorca, Spain, 07198
        • Hospital Son Llatzer
  • Sweden
      • Lund, Sweden, 221 85
        • Universitetssjukhus Lund, Hematologkliniken
      • Stockholm, Sweden, 17176
        • Hematology Center
  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Chang Gung Medical Foundation, Kaohsiung Branch
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
  • United Kingdom
      • Bristol, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology centre
      • Hull, United Kingdom, HU16 5JQ
        • Castle Hill Hospital
      • London, United Kingdom, NW3 2QG
        • Department of Academic Oncology
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospitals NHS Trust
      • Oxford, United Kingdom, OX3 7LJ
        • Churchill Hospital
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Southampton General Hospital
  • United States
    • California
      • La Jolla, California, United States, 92093-0698
        • UC San Diego Moores Cancer Center
      • La Jolla, California, United States, 92037
        • UC San Diego Medical Center - La Jolla
      • La Jolla, California, United States, 92037-0845
        • Investigational Drug Services - UC San Diego Moores Cancer Center
      • Los Angeles, California, United States, 90033
        • Usc Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90033
        • Keck Hospital of USC
      • Los Angeles, California, United States, 90095
        • UCLA Hematology/Oncology Clinic
      • Los Angeles, California, United States, 90095
        • UCLA Ronald Reagan Medical Center
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center / Investigational Drug Services
      • Los Angeles, California, United States, 90033
        • LAC+USC Medical Center
      • Los Angeles, California, United States, 90027
        • Children's Center for Cancer and Blood Diseases, Childrens Hospital Los Angeles
      • Los Angeles, California, United States, 90095
        • UCLA Drug Information/Investigation Drug
      • Los Angeles, California, United States, 90095
        • UCLA Rrmc
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
      • Orange, California, United States, 92868
        • UC Irvine Medical Center
      • Orange, California, United States, 92868-3201
        • UC Irvine Medical Center
      • Palo Alto, California, United States, 94304
        • Freidenrich Center for Translational Research (CTRU), Stanford University
      • San Diego, California, United States, 92103
        • UC San Diego Medical Center - Hillcrest
      • Stanford, California, United States, 94305
        • Stanford Cancer Institute
      • Stanford, California, United States, 94305
        • Stanford University Hospital and Clinics
      • Stanford, California, United States, 94305
        • Martha Hamilton, Investigational Drug Services, Dept of Pharmacy
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital, Cancer Center Infusion Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale-New Haven Hospital & Smilow Cancer Center
    • Florida
      • Miami, Florida, United States, 33155
        • Miami Children's Hospital
      • Orlando, Florida, United States, 32806
        • MD Anderson Cancer Center Orlando
      • Orlando, Florida, United States, 32806
        • Orlando Regional Medical Center
      • Orlando, Florida, United States, 32806
        • MD Anderson Cancer Center Orlando - 5th Floor Investigational Pharmacy
      • Orlando, Florida, United States, 32806
        • Orlando Heart Health Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute, Emory University
      • Atlanta, Georgia, United States, 30342
        • Blood and Marrow Transplant Group of Georgia
      • Atlanta, Georgia, United States, 30322
        • The Emory Clinic
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
      • Atlanta, Georgia, United States, 30322
        • Investigational Drug Service, Emory University Clinic
      • Augusta, Georgia, United States, 30912
        • Georgia Regents University
      • Augusta, Georgia, United States, 30912
        • Georgia Regents Medical Center Pharmacy, Georgia Regents University Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Chicago, Illinois, United States, 60637
        • The University of Chicago
      • Chicago, Illinois, United States, 60611
        • Northwestern Medical Faculty Foundation
      • Chicago, Illinois, United States, 60611
        • Northwestern Medicine Developmental Therapeutics Institute
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center, Dept. of Pharmacy
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Hospital
      • Westwood, Kansas, United States, 66205
        • University of Kansas Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute, Suburban
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
      • Baltimore, Maryland, United States, 21231-2410
        • Oncology Investigational Drug Service
      • Baltimore, Maryland, United States, 21231-2410
        • The Sidney Kimmel Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital (MGH)
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System-
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
      • Farmington Hills, Michigan, United States, 48334
        • Karmanos Cancer Institute Weisberg Cancer Treatment Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • University of New Mexico Comprehensive Cancer Center
      • Albuquerque, New Mexico, United States, 87131
        • UNM Cancer Center
    • New York
      • Lake Success, New York, United States, 11042
        • Monter Cancer Center
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10065
        • NewYork-Presbyterian Hospital
      • New York, New York, United States, 10065
        • Weill Cornell Medical College - New York-Presbyterian Hospital
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital-Weill Cornell Medical College
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
      • Stony Brook, New York, United States, 11794-7007
        • Stony Brook University Medical Center
      • Stony Brook, New York, United States, 11794-9447
        • Stony Brook University Medical Center, The Cancer Center
      • Stony Brook, New York, United States, 11794
        • Division of Hematology/Oncology, Stony Brook University Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Cancer Hospital Infusion Pharmacy
      • Chapel Hill, North Carolina, United States, 27599-7600
        • UNC Hospitals - The University of North Carolina at Chapel Hill
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Of Cleveland
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Stephenson Cancer Center
      • Oklahoma City, Oklahoma, United States, 73104
        • OU Medical Center Presbyterian Tower
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • IDS-investigational drug pharmacy Penn State Milton S. Hershey Medical Center
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center,
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center
      • Charleston, South Carolina, United States, 29425
        • MUSC Hospital
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Dallas, Texas, United States, 75246
        • Baylor Charles A. Sammons Cancer Center
      • Dallas, Texas, United States, 75235
        • Parkland Health and Hospital System
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center at Dallas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Universtiy Hospital - William P Clements Jr.
      • Dallas, Texas, United States, 75390
        • UT Southwestern University Hospital- Zale Lipshy
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, United States, 98195
        • University of Washington
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Hospitals
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Hospitals Pharmaceutical Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • CD22 expression
  • Adequate liver and renal functions

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm A
Drug: inotuzumab ozogamicin
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
ACTIVE_COMPARATOR: Arm B
Drug: FLAG (fludarabine, cytarabine and G-CSF)
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
Drug: HIDAC (high dose cytarabine)
cytarabine 3 g/m^2 IV every 12 hours for up to 12 times
Drug: cytarabine and mitoxantrone
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC)
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
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.
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
Overall Survival (OS)
Time Frame: Up to 5 years after randomization or 2 years from randomization of the last participant, whichever occurs first.
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.
Up to 5 years after randomization or 2 years from randomization of the last participant, whichever occurs first.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment)
Time Frame: Up to 2 years from randomization
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.
Up to 2 years from randomization
Progression-Free Survival (PFS)
Time Frame: Up to 2 years from randomization
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.
Up to 2 years from randomization
Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT)
Time Frame: Up to 19 weeks from last dose
HSCT rate was defined as the percentage of participants who underwent SCT following treatment with inotuzumab ozogamicin or Investigator's choice of chemotherapy.
Up to 19 weeks from last dose
Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment)
Time Frame: Up to approximately 4 weeks (EoT) from last dose of study drug
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.
Up to approximately 4 weeks (EoT) from last dose of study drug
Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment)
Time Frame: Up to approximately 4 weeks (EoT) from last dose of study drug
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.
Up to approximately 4 weeks (EoT) from last dose of study drug
Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) and Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing
Time Frame: Days 1, 4, 8, and 15 of Cycle 1, Days 1 and 8 of Cycle 2 and Day 1 of Cycle 4
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).
Days 1, 4, 8, and 15 of Cycle 1, Days 1 and 8 of Cycle 2 and Day 1 of Cycle 4
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) Score
Time Frame: Day 1 of each cycle prior to dosing and EoT
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.
Day 1 of each cycle prior to dosing and EoT
Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score
Time Frame: Day 1 of each cycle prior to dosing and EoT
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).
Day 1 of each cycle prior to dosing and EoT
Change From Baseline in EQ-5D VAS
Time Frame: Day 1 of each cycle prior to dosing and EoT
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.
Day 1 of each cycle prior to dosing and EoT
Percentage of Participants With Veno-Occlusive Liver Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Following Post Study HSCT
Time Frame: Up to 2 years from randomization
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.
Up to 2 years from randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

UCB Pharma

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 2, 2012

Primary Completion (ACTUAL)

March 8, 2016

Study Completion (ACTUAL)

January 4, 2017

Study Registration Dates

First Submitted

March 26, 2012

First Submitted That Met QC Criteria

March 26, 2012

First Posted (ESTIMATE)

March 28, 2012

Study Record Updates

Last Update Posted (ACTUAL)

January 9, 2019

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1931022
  • 2011-005491-41 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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