A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy

AN OPEN-LABEL, RANDOMIZED, PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN ADMINISTERED IN COMBINATION WITH RITUXIMAB COMPARED TO DEFINED INVESTIGATOR'S CHOICE THERAPY IN SUBJECTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE AGGRESSIVE NON-HODGKIN LYMPHOMA WHO ARE NOT CANDIDATES FOR INTENSIVE HIGH-DOSE CHEMOTHERAPY

The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of this combination compared with an active comparator arm (investigator's choice of rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall survival.

Study Overview

• Status: Terminated
• Conditions: Lymphoma, Non-Hodgkin
• Intervention / Treatment: Drug: Inotuzumab ozogamicin; Drug: Rituximab; Drug: rituximab + gemcitabine; Drug: rituximab +bendamustine

• Study Type: Interventional
• Enrollment (Actual): 338
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1000
    • Institut Jules Bordet
  • Charleroi, Belgium, 6000
    • Grand Hopital de Charleroi
  • Roeselare, Belgium, 8800
    • H.-Hartziekenhuis Roeselare-Menen
  • Wilrijk, Belgium, 2610
    • St Augustinus ziekenhuis
  • Yvoir, Belgium, 5530
    • Cliniques universitaires UCL de Mont-Godinne,
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • Universitaire Ziekenhuizen Leuven
• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • UMBAL Sveti Georgi, Klinika po hematologia
  • Sofia, Bulgaria, 1756
    • SBAL na Hematologichnichni Zabolyavania,CTH Sofia
  • Sofia, Bulgaria, 1756
    • Spetsializirana Bolnitsa za Aktivno Lechenie na Hematologichni Zabolyavania, CTH Sofia
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Centre
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • Ontario
    • Toronto, Ontario, Canada, M4N 3 M5
      • SunnyBrook Health Sciences Centre
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke (CHUS), Hopital Fleurimont
• Croatia
  • Zagreb, Croatia, 10000
    • University Hospital Zagreb
  • Zagreb, Croatia, 10010
    • University Hospital Dubrava Department of Internal Medicine Division of Hematology
• Czechia
  • Brno, Czechia, 62500
    • Fakultni nemocnice Brno
  • Czech Republic
    • Praha 10, Czech Republic, Czechia, 100 34
      • Fakultni nemocnice Kralovske Vinohrady
• France
  • Lyon, France, 69373
    • Centre LEON BERARD
  • Montpellier, France, 34295Cedex5
    • CHU Saint Eloi
  • Pessac, France, 33600
    • Hôpital du Haut Lévêque
  • Rouen, France, 76038
    • Centre Henri Becquerel
  • Bouches-du-rhône
    • Marseille, Bouches-du-rhône, France, Cedex 09 13273
      • Département Pharmacie
  • Cedex 09
    • Marseille, Cedex 09, France, 13273
      • Institut Paoli Calmettes
  • Yvelines
    • Le Chesnay, Yvelines, France, 78157
      • Hôpital André Mignot
    • Le Chesnay Cedex, Yvelines, France, 78157
      • Hospital Universitaire Andre Mignot
• Germany
  • Aachen, Germany, 52074
    • Universitaetsklinikum Aachen
  • Bamberg, Germany, 96049
    • Sozialstiftung Bamberg
  • Berlin, Germany, 13353
    • Charité Campus Virchow-Klinikum
  • Berlin, Germany, 10117
    • Charite Campus Benjamin Franklin
  • Mainz, Germany, 55101
    • Universitaetsklinikum Mainz
  • Muenchen, Germany, 81675
    • TU Muenchen III. Medizinische Klinik
  • Ulm, Germany, 89081
    • Universitaetsklinik Ulm
• Hungary
  • Budapest, Hungary, 1097
    • Egyesitett Szent Istvan es Szent Laszlo Korhaz /
  • Debrechen, Hungary, 4032
    • DEOEC, Belgyogyaszati Intezet
  • Kaposvar, Hungary, 7400
    • Somongy Megyei Kaposi Mor Okato Korhaz/ Belgyogyaszati osztaly
• India
  • Maharashtra
    • Aurangabad, Maharashtra, India, 431 005
      • Kodlikeri Memorial Hospital
    • Pune, Maharashtra, India, 411004
      • Sahyadri Speciality Hospital
    • Pune, Maharashtra, India, 411 004
      • Sahyadri Clinical Research And Development Center
    • Pune, Maharashtra, India, 411004
      • OEC Record Management Company Pvt. Ltd.,
• Ireland
  • Cork, Ireland
    • Bon Secours Hospital
• Japan
  • Akita, Japan, 010-8543
    • Akita University Hospital
  • Fukuoka, Japan, 811-1395
    • National Kyushu Cancer Center
  • Kanagawa, Japan, 259-1193
    • Tokai University Hospital
  • Kyoto, Japan, 602-8566
    • University Hospital, Kyoto Prefectural University of Medicine
  • Aichi
    • Nagoya, Aichi, Japan, 4668650
      • Nagoya Daini Red Cross Hospital
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Ehime
    • Toon-shi, Ehime, Japan, 791-0295
      • Ehime University Hospital
  • Gunma
    • Maebashi-city, Gunma, Japan, 371-8511
      • Gunma University Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Tohoku University Hospital
  • Osaka
    • Moriguchi, Osaka, Japan, 570-8540
      • Matsushita Memorial Hospital
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
    • Koto-Ku, Tokyo, Japan, 135-8550
      • Cancer Institute Hospital, Japanese Foundation For Cancer Research
• Lithuania
  • Klaipeda, Lithuania, 92288
    • Klaipeda Seamen's Hospital, Public Institution, department of Oncology
• Mexico
  • Aguascalientes. Mexico
    • Aguascalientes, Aguascalientes. Mexico, Mexico, 20127
      • Instituto Biomedico De Investigacion A.C.
• Poland
  • Warszawa, Poland, 02-781
    • Klinika Nowotworow Ukladu Chlonnego
  • Warszawa, Poland, 00-728
    • Niepubliczny Zaklad Opieki Zdrowotnej AVI Diagnostyka Obrazowa
• Puerto Rico
  • Catano, Puerto Rico, 00962
    • Advanced Infusion Services
  • San Juan, Puerto Rico, 00918
    • Hospital Espanol Auxilio Mutuo de Puerto Rico Inc
• Russian Federation
  • Moscow, Russian Federation, 125167
    • Federal State Budgetary Institution Hematology Scientific Centre of Ministry of
  • Moscow, Russian Federation, 125284
    • Moscow State Healthcare Institution City clinical hospital S.P. Botkin
  • Saint-Petersburg, Russian Federation, 197022
    • Institute of Pediatric Hematology and Transplantology R.M.Gorbacheva
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 119074
    • National University Hospital
• Slovakia
  • Bratislava, Slovakia, 833 10
    • Narodny Onkologicky Ustav
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic de Barcelona
  • Barcelona, Spain, 08036
    • Hospital Clinic Universitari de Barcelona
  • L'Hospitalet De Llobregat (bcn), Spain, 08907
    • Institut Catala d'Oncologia-L'Hospitalet
  • La Laguna (Tenerife), Spain, 38320
    • Hospital Universitario de Canarias
  • Madrid, Spain, 28006
    • Hospital de La Princesa
  • Andalucia
    • Sevilla, Andalucia, Spain, 41013
      • Hospital Virgen del Rocío
  • Castille AND LION
    • Salamanca, Castille AND LION, Spain, 37007
      • Hospital Universitario de Salamanca
• Sweden
  • Linkoping, Sweden, 58185
    • Universitetssjukhuset
  • Lund, Sweden, 221 85
    • Skanes Universitetssjukhus I Lund
• Taiwan
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital, Department of Internal Medicine
  • Taoyuan County
    • Kuei-Shan Hsiang, Taoyuan County, Taiwan, 333
      • Chang Gung Medical Foundation - Linkou Branch
• Thailand
  • Chiang Mai, Thailand, 50200
    • Chiang Mai University
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Hematology Division Department of Medicine Faculty of Medicine Siriraj Hospital Mahidol University
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Regional Treatment and Diagnostic Hematology Center Communal Establishment
  • Dnipropetrovsk, Ukraine, 49102
    • Department of Oncology and Medical Radiology of State Institution
  • Kyiv, Ukraine, 03115
    • SI"Research Center for Radiation Medicine of NAMS of Ukraine"
• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • Barts Cancer Centre Dept Haemato-oncology St. Bartholomew's Hospital Barts Health NHS Trust
  • London, United Kingdom, EC1A 7BE
    • Chemotherapy Preparative Unit St. Bartholomew's Hospital
  • London, United Kingdom, EC1A 7BE
    • Department of Medical Oncology St. Bartholomew's Hospital
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation Trust - Christie Hospital
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Northern Centre for Cancer Care
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Department of Clinical Pathology Newcastle upon Tyne Hospitals NHS Foundation Trust Royal Victoria I
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Department of Clinical Biochemistry Newcastle upon Tyne Hospitals
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham University Hospital
  • Nottingham, United Kingdom, NG5 1PB
    • Pathology Department Nottingham University Hospital - City Hospital Campus
  • Nottingham, United Kingdom, NG5 1PB
    • Pharmacy Nottingham University Hospital - City Hospital Campus
  • Nottingham, United Kingdom, NG51PB
    • Local Laboratory Nottingham University Hospital - City Hospital Campus
  • Wolverhampton, United Kingdom, WV10 0QP
    • New Cross Hospital
• United States
  • California
    • Burbank, California, United States, 91505
      • Providence St Joseph Medical Center
    • Burbank, California, United States, 91505
      • Disney Family Cancer Center at Providence St Joseph Medical Center
    • Fresno, California, United States, 93720
      • Hematology-Oncology Medical Group of Fresno Inc
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
    • Los Angeles, California, United States, 90095-6981
      • Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services
    • Los Angeles, California, United States, 90095
      • Clinical Research Unit
    • Los Angeles, California, United States, 90095
      • Peter Morton Medical Plaza
    • Santa Barbara, California, United States, 93105
      • Sansum Clinic
    • Santa Monica, California, United States, 90404
      • UCLA Santa Monica Hematology Oncology
    • Solvang, California, United States, 93463
      • Sansum Clinic
  • District of Columbia
    • Washington, District of Columbia, United States, 20060
      • Howard University Hospital
  • Florida
    • Aventura, Florida, United States, 33180
      • Mount Sinai Comprehensive Cancer Center at Aventura
    • Boynton Beach, Florida, United States, 33426
      • University Cancer Institute
    • Fernandina Beach, Florida, United States, 32034
      • 21st Century Oncology of Jacksonville, LLC
    • Gainesville, Florida, United States, 32610
      • Shands Hospital at the University of Florida
    • Gainesville, Florida, United States, 32610
      • UF Health Shands Hospital
    • Gainesville, Florida, United States, 32608
      • UF Health Shands Cancer Hospital
    • Gainesville, Florida, United States, 32608
      • UF Health Davis Cancer Pavillion and Shands Med Plaza
    • Gainesville, Florida, United States, 32608
      • Shands Cancer Hospital at the University of Florida
    • Gainesville, Florida, United States, 32608
      • Davis Cancer Pavilion and Shands Medical Plaza
    • Jacksonville, Florida, United States, 32207
      • Baptist Medical Center
    • Jacksonville, Florida, United States, 32207
      • Baptist Cancer Institute
    • Jacksonville, Florida, United States, 32205
      • 21st Century Oncology of Jacksonville, LLC
    • Jacksonville, Florida, United States, 32207
      • 21st Century Oncology of Jacksonville, LLC
    • Jacksonville, Florida, United States, 32256
      • 21st Century Oncology of Jacksonville, LLC
    • Jacksonville, Florida, United States, 32258
      • 21st Century Oncology of Jacksonville, Inc.
    • Lake Worth, Florida, United States, 33467
      • Medical Specialists of the Palm Beaches
    • Miami, Florida, United States, 33133
      • Mercy Hospital
    • Miami, Florida, United States, 33133
      • Mercy Research Institute
    • Miami, Florida, United States, 33133
      • Advanced Medical Specialties
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Comprehensive Cancer Center
    • Orange Park, Florida, United States, 32073
      • 21st Century Oncology of Jacksonville, LLC
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Regents University
    • Augusta, Georgia, United States, 30912
      • Georgia Regents Medical Cancer Pharmacy
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • Kootenai Cancer Center
    • Post Falls, Idaho, United States, 083854
      • Kootenai Cancer Center
  • Illinois
    • Decatur, Illinois, United States, 62526
      • Decatur Memorial Hospital (DMH)
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Floyd Memorial Cancer Center of Indiana
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
    • Westwood, Kansas, United States, 66205
      • University of Kansas Cancer Center and Medical Pavilion
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Markey Cancer Center
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky A.B. Chandler Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Hospital and Clinic
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Karmanos Cancer Institute
    • Farmington Hills, Michigan, United States, 48334
      • Barbara Ann Karmanos Cancer Institute at farmington Hills
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55426
      • Park Nicollet Frauenshuh Cancer Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • Saint Louis, Missouri, United States, 63110
      • Washington University
    • Saint Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St Louis
    • Saint Peters, Missouri, United States, 63376
      • Barnes-Jewish St. Peters
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10003
      • Beth Israel Medical Center;
    • New York, New York, United States, 10011-5903
      • Beth Israel Comprehensive Cancer Center
    • New York, New York, United States, 10019
      • St Luke's- Roosevelt Hospital Center
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center, The Cancer Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University Hospital
    • West Chester, Ohio, United States, 45069
      • West Chester Hospital Medical Building
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • OU Medical Center Presbyterian Tower
    • Oklahoma City, Oklahoma, United States, 73104
      • OU Medical Center Presbyterian Professional Building
    • Oklahoma City, Oklahoma, United States, 73104
      • Peggy and Charles Stephenson Cancer Center (chemo & infusion)
    • Oklahoma City, Oklahoma, United States, 73104
      • Peggy and Charles Stephenson Cancer Center (clinic location)
  • Oregon
    • Corvallis, Oregon, United States, 97330
      • Good Samaritan Hospital Corvallis
    • Corvallis, Oregon, United States, 97330
      • Good Samaritan Hospital, Corvallis
    • Corvallis, Oregon, United States, 97330
      • Samaritan Ambulatory Infusion Services
    • Newport, Oregon, United States, 97365
      • Samaritan Pacific Coast Hospital
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Clinic, Ltd.
    • Sayre, Pennsylvania, United States, 18840
      • Robert Packer Hospital
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • Thompson Oncology Group
    • Knoxville, Tennessee, United States, 37932
      • Thompson Oncology Group
    • Maryville, Tennessee, United States, 37804
      • Thompson Oncology Group
    • Sevierville, Tennessee, United States, 37862
      • Thompson Oncology Group
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
    • Dallas, Texas, United States, 75390
      • Simmons Comprehensive Cancer Center
    • Dallas, Texas, United States, 75235
      • University Hospital - St. Paul
    • Dallas, Texas, United States, 75235
      • University Hospital - Zale Lipshy
    • Dallas, Texas, United States, 75246
      • Baylor: Charles A. Sammons Cancer Center
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center

Participation Criteria

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:

-

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Inotuzumab ozogamicin+rituximab	Drug: Inotuzumab ozogamicin; 1.8 mg/m2 on day 2 every 28 days by IV infusion, 3 to 6 cycles; Other Names: CMC-544; Drug: Rituximab; 375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles
Active Comparator: 2; Investigator's choice of (1) rituximab+gemcitabine, or (2) rituximab+bendamustine	Drug: rituximab + gemcitabine; rituximab 375 mg/m2 on days 1, 8, 15, and 22 of cycle 1, and day 1 of cycles 2 to 6, every 28 days by IV infusion, 3 to 6 cycles; gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days, 3 to 6 cycles; Drug: rituximab +bendamustine; rituximab 375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles; bendamustine 120 mg/m2 on days 1 and 2 by IV infusion every 28 days, 3 to 6 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall Survival (OS) was defined as the time from randomization to death due to any cause, censoring at the date of last contact or the end of the study. The Kaplan-Meier method was used to determine OS. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.	From randomization up to 5 years after last dose or up to final study visit, whichever occurs first.
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)	Includes all TEAEs: Any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration..	Up to 20 weeks after the first dose of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	PFS is defined as time from date of randomization to date of progressive disease (PD, including investigator's claim of clinical progression), date of death from any cause, or initiation of a new treatment for the lymphoma due to persistent/refractory disease. The Kaplan-Meier method was used to determine PFS. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression. PD requires the following: Appearance of any new lesion more than 1.5 cm in any axis during or at the end of treatment, even if other lesions are decreasing in size.; At least a 50% increase from nadir in the sum of the product diameters of any previously involved nodes, or in a single involved node, or the size of other lesions.; At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis.	From randomization up to 2 years or final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.
Percentage of Participants With A Best Overall Response of CR or Partial Response (PR) Per NCI International Response Criteria for NHL	CR is defined as disappearance of all detectable clinical evidence of disease (including cleared infiltrate on repeat bone marrow aspirate/biopsy if lymphoma involvement of bone marrow before treatment). Partial Response (PR) requires the following: ≥50 % decrease in SPD of the six largest dominant nodes or nodal masses.; No increase in the size of other nodes, liver, or spleen.; Splenic and hepatic nodules must regress by ≥50% in the SPD, or for single nodules, in the greatest transverse diameter.; With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.; No new sites of disease. The 95% CI was determined using the exact method based on binomial distribution.	Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.
Percentage of Participants With A Best Overall Response of CR, Unconfirmed CR (unCR), PR, or Unconfirmed PR (unPR) Per NCI International Response Criteria for NHL	CR is defined as disappearance of all detectable clinical evidence of disease (including cleared infiltrate on repeat bone marrow aspirate/biopsy if lymphoma involvement of bone marrow before treatment). Partial Response (PR) requires the following: ≥50 % decrease in SPD of the six largest dominant nodes or nodal masses.; No increase in the size of other nodes, liver, or spleen.; Splenic and hepatic nodules must regress by ≥50% in the SPD, or for single nodules, in the greatest transverse diameter.; With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.; No new sites of disease. unCR and unPR means didn't have confirmatory assessment (including bone marrow assessment for CR). The 95% CI was determined using the exact method based on binomial distribution.	Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.
Duration of Response	The duration of overall response is measured from the first date of response until the first date that the progressive disease (PD) or death is objectively documented. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.	Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.
Health Status as Assessed by the European Quality of Life 5 Dimension (EQ-5D) Questionnaire	EQ-5D consists of a descriptive system and an EQ visual analogue scale. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The scale, the best state is marked 100 and the worst state is marked 0, is to help the participant to say how good or bad a health state is. EQ-5D index, which was reported, was derived based on US weight. The range of EQ-5D index is -0.109 to 1.00. Higher scores mean better outcomes. The average post-baseline scores for EQ-5D index were computed at approximately Week 12. The overall treatment comparisons were estimated at approximately Week 12.	Assessed at Day 1 of each cycle and 6-9 weeks after the last dose, Cycle 3 (Week 12) reported
Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy for Lymphoma (FACT-Lym) Questionnaire	FACT-Lym is a questionnaire that begins with 27 items covering four core Health-Related Quality of Life subscales: Physical Well-being (7 items), Social/Family Well-being (7), Emotional Well-being (6), and Functional Well-being (7). The FACT-Lym also includes an additional concerns subscale (15 items). It also asks participants about their concerns about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. The participants were requested to circle one number on a 0 to 4 points scale per line to indicate how true each statement has been for him/her during the past 7 days. FACT-Lym total score, which was reported, was derived based on FACT-Lym scoring guideline (Version 4). The range of FACT-Lym total score is 0 to 168. Higher scores mean better outcomes. The average post-baseline FACT-Lym total scores were computed at approximately Week 12. The overall treatment comparisons were estimated at approximately Week 12.	Assessed at Day 1 of each cycle and 6-9 weeks after the last dose, Cycle 3 (Week 12) reported

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: UCB Pharma

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2011
• Primary Completion (Actual): March 28, 2014
• Study Completion (Actual): March 28, 2014

Study Registration Dates

• First Submitted: October 27, 2010
• First Submitted That Met QC Criteria: October 29, 2010
• First Posted (Estimate): November 2, 2010

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: inotuzumab ozogamicin; diffuse large b-cell lymphoma; aggressive Non-Hodgkin lymphoma; relapsed/refractory lymphoma
• Additional Relevant MeSH Terms: Behavioral Symptoms; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Aggression; Lymphoma; Lymphoma, Non-Hodgkin; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Antineoplastic Agents, Immunological; Antibiotics, Antineoplastic; Gemcitabine; Bendamustine Hydrochloride; Rituximab; Inotuzumab Ozogamicin
• Other Study ID Numbers: B1931008; 3129K5-3303 (Other Identifier: Alias Study Number); 2010-020147-12 (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.