Trial record 1 of 1 for:    B1931008
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A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy

This study has been terminated.
(The study was terminated prematurely on May 16, 2013, for futility. No new or unexpected safety issues were identified.)
Sponsor:
Collaborator:
UCB, Inc.
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01232556
First received: October 27, 2010
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Lymphoma, Non-Hodgkin
Drug: Inotuzumab ozogamicin
Drug: Rituximab
Drug: rituximab + gemcitabine
Drug: rituximab +bendamustine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Tolerability: incidence of adverse events by treatment arm. [ Time Frame: ~every 6 months ] [ Designated as safety issue: Yes ]
  • Efficacy: overall response rate, progression free survival, duration of response [ Time Frame: at ~3 to 6 months after start of treatment, and ~2 years after start of treatment ] [ Designated as safety issue: No ]

Enrollment: 340
Study Start Date: April 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • relapsed/refractory/persistent CD20+/CD22+ aggressive NHL (DLBCL, transformed indolent lymphoma with DLBCL, primary mediastinal large B-cell lymphomas)
  • up to 3 prior regimens containing cytotoxic chemotherapies
  • not candidates for intensive high-dose chemotherapy, with or without an autologous stem cell transplant

Exclusion Criteria:

  • Any prior allogeneic hematopoietic stem cell transplant; autotransplant within prior 4 months
  • anti-CD22 treatment or radioimmunotherapy within prior 6 months
  • contraindication to both investigator choice regimens
  • chronic liver disease, history of veno-occlusive disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232556

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Locations
United States, California
Pfizer Investigational Site
Burbank, California, United States, 91505
Pfizer Investigational Site
Fresno, California, United States, 93720
Pfizer Investigational Site
Los Angeles, California, United States, 90095
Pfizer Investigational Site
Los Angeles, California, United States, 90095-6981
Pfizer Investigational Site
Santa Barbara, California, United States, 93105
Pfizer Investigational Site
Santa Monica, California, United States, 90404
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20060
United States, Florida
Pfizer Investigational Site
Aventura, Florida, United States, 33180
Pfizer Investigational Site
Boynton Beach, Florida, United States, 33437
Pfizer Investigational Site
Boynton Beach, Florida, United States, 33426
Pfizer Investigational Site
Deerfield Beach, Florida, United States, 33441
Pfizer Investigational Site
Fernandina Beach, Florida, United States, 32034
Pfizer Investigational Site
Gainesville, Florida, United States, 32608
Pfizer Investigational Site
Gainesville, Florida, United States, 32610
Pfizer Investigational Site
Jacksonville, Florida, United States, 32256
Pfizer Investigational Site
Jacksonville, Florida, United States, 32205
Pfizer Investigational Site
Jacksonville, Florida, United States, 32207
Pfizer Investigational Site
Lake Worth, Florida, United States, 33467
Pfizer Investigational Site
Miami, Florida, United States, 33133
Pfizer Investigational Site
Miami Beach, Florida, United States, 33140
United States, Georgia
Pfizer Investigational Site
Augusta, Georgia, United States, 30912
United States, Idaho
Pfizer Investigational Site
Coeur d' Alene, Idaho, United States, 83814
Pfizer Investigational Site
Post Falls, Idaho, United States, 83854
United States, Illinois
Pfizer Investigational Site
Decatur, Illinois, United States, 62526
United States, Indiana
Pfizer Investigational Site
New Albany, Indiana, United States, 47150
United States, Kansas
Pfizer Investigational Site
Kansas City, Kansas, United States, 66160
Pfizer Investigational Site
Westwood, Kansas, United States, 66205
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40536
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70112
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
Pfizer Investigational Site
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
Pfizer Investigational Site
St. Louis Park, Minnesota, United States, 55426
United States, Missouri
Pfizer Investigational Site
Saint Louis, Missouri, United States, 63110
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
United States, Nebraska
Pfizer Investigational Site
Lincoln, Nebraska, United States, 68516
Pfizer Investigational Site
Lincoln, Nebraska, United States, 68510
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10003
Pfizer Investigational Site
New York, New York, United States, 10011
Pfizer Investigational Site
New York, New York, United States, 10021
Pfizer Investigational Site
New York, New York, United States, 10019
Pfizer Investigational Site
Stony Brook, New York, United States, 117948151
Pfizer Investigational Site
Stony Brook, New York, United States, 11794
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
Pfizer Investigational Site
West Chester, Ohio, United States, 45069
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Pfizer Investigational Site
Corvallis, Oregon, United States, 97330
Pfizer Investigational Site
Newport, Oregon, United States, 97365
United States, Pennsylvania
Pfizer Investigational Site
Hershey, Pennsylvania, United States, 17033
Pfizer Investigational Site
Sayre, Pennsylvania, United States, 18840
United States, Tennessee
Pfizer Investigational Site
Knoxville, Tennessee, United States, 37916
Pfizer Investigational Site
Knoxville, Tennessee, United States, 37932
Pfizer Investigational Site
Maryville, Tennessee, United States, 37804
Pfizer Investigational Site
Sevierville, Tennessee, United States, 37862
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75246
Pfizer Investigational Site
Dallas, Texas, United States, 75235
Pfizer Investigational Site
Dallas, Texas, United States, 75390-9113
Pfizer Investigational Site
Dallas, Texas, United States, 75390
Pfizer Investigational Site
Houston, Texas, United States, 77030
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1000
Pfizer Investigational Site
Charleroi, Belgium, 6000
Pfizer Investigational Site
Leuven, Belgium, 3000
Pfizer Investigational Site
Roeselare, Belgium, 8800
Pfizer Investigational Site
Wilrijk, Belgium, 2610
Pfizer Investigational Site
Yvoir, Belgium, 5530
Bulgaria
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Plovdiv, Bulgaria, 4002
Pfizer Investigational Site
Sofia, Bulgaria, 1756
Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada, T2N 4N2
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Pfizer Investigational Site
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Pfizer Investigational Site
Sherbrooke, Quebec, Canada, J1H 5N4
Croatia
Pfizer Investigational Site
Zagreb, Grad Zagreb, Croatia, 10000
Pfizer Investigational Site
Zagreb, Croatia, 10000
Czech Republic
Pfizer Investigational Site
Brno, Czech Republic, 62500
Pfizer Investigational Site
Prague, Czech Republic, 10034
France
Pfizer Investigational Site
Marseille, Cedex 09, France, 13273
Pfizer Investigational Site
Le Chesnay Cedex, France, 78157
Pfizer Investigational Site
Lyon, France
Pfizer Investigational Site
Montpellier, France, 34295Cedex5
Pfizer Investigational Site
Pessac, France, 33600
Pfizer Investigational Site
Rouen, France, 76038
Germany
Pfizer Investigational Site
Aachen, Germany, 52074
Pfizer Investigational Site
Bamberg, Germany, 96049
Pfizer Investigational Site
Berlin, Germany, 13353
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Mainz, Germany, 55131
Pfizer Investigational Site
Mainz, Germany
Pfizer Investigational Site
Munich, Germany, 81675
Pfizer Investigational Site
Ulm, Germany, 89081
Hungary
Pfizer Investigational Site
Budapest, Hungary, 1097
Pfizer Investigational Site
Debrecen, Hungary, 4032
Pfizer Investigational Site
Kaposvar, Hungary, 7400
India
Pfizer Investigational Site
Aurangabad, Maharashtra, India, 431 005
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Pune, Maharashtra, India, 411004
Pfizer Investigational Site
Pune, Maharashtra, India, 411 004
Ireland
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Cork, Ireland
Japan
Pfizer Investigational Site
Nagoya, Aichi, Japan
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Kashiwa, Chiba-Ken, Japan
Pfizer Investigational Site
Toon-shi, Ehime, Japan
Pfizer Investigational Site
Maebashi-City, Gunma, Japan
Pfizer Investigational Site
Kyoto, Kamigyo-ku, Japan
Pfizer Investigational Site
Sendai, Miyagi, Japan
Pfizer Investigational Site
Moriguchi, Osaka, Japan
Pfizer Investigational Site
Sunto-gun, Shizuoka, Japan
Pfizer Investigational Site
Chuo-ku, Tokyo, Japan
Pfizer Investigational Site
Akita, Japan
Pfizer Investigational Site
Fukuoka, Japan
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Kanagawa, Japan
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Tokyo, Japan
Lithuania
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Klaipeda, Lithuania, 92288
Mexico
Pfizer Investigational Site
Aguascalientes, Aguascalientes. Mexico, Mexico, 20127
Poland
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Warszawa, Poland, 00-728
Pfizer Investigational Site
Warszawa, Poland, 02-781
Puerto Rico
Pfizer Investigational Site
San Juan, Puerto Rico, 00918
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 125284
Pfizer Investigational Site
Moskva, Russian Federation, 125167
Pfizer Investigational Site
Saint-Petersburg, Russian Federation, 197022
Singapore
Pfizer Investigational Site
Singapore, Singapore, 169608
Pfizer Investigational Site
Singapore, Singapore, 119228
Slovakia
Pfizer Investigational Site
Bratislava, Slovakia, 833 10
Spain
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Pfizer Investigational Site
Barcelona, Spain, 08036
Pfizer Investigational Site
Barcelona., Spain, 8036
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Madrid, Spain, 28006
Pfizer Investigational Site
Salamanca,, Spain, 37007
Pfizer Investigational Site
Santa Cruz de Tenerife, Spain, 38320
Pfizer Investigational Site
Sevilla, Spain
Pfizer Investigational Site
Sevilla, Spain, 41013
Sweden
Pfizer Investigational Site
Linkoping, Sweden
Pfizer Investigational Site
Linkoping, Sweden, 581 85
Pfizer Investigational Site
Lund, Sweden, 221 85
Taiwan
Pfizer Investigational Site
Kwei-Shan, Taoyun, Taiwan, 333
Pfizer Investigational Site
Taichung, Taiwan, 407
Pfizer Investigational Site
Taipei, Taiwan, 100
Pfizer Investigational Site
Taipei, Taiwan, 11217
Thailand
Pfizer Investigational Site
Bangkoknoi, Bangkok, Thailand, 10700
Pfizer Investigational Site
Chiang Mai, Thailand, 50200
Ukraine
Pfizer Investigational Site
Cherkasy, Ukraine, 18009
Pfizer Investigational Site
Dnipropetrovsk, Ukraine, 49102
Pfizer Investigational Site
Kyiv, Ukraine, 03115
United Kingdom
Pfizer Investigational Site
London, United Kingdom, EC1M 6BQ
Pfizer Investigational Site
London, United Kingdom, EC1A 7BE
Pfizer Investigational Site
London, United Kingdom
Pfizer Investigational Site
Manchester, United Kingdom, M20 4BX
Pfizer Investigational Site
Newcastle upon Tyne, United Kingdom, NE7 7DN
Pfizer Investigational Site
Nottingham, United Kingdom
Pfizer Investigational Site
Nottingham, United Kingdom, NG5 1PB
Pfizer Investigational Site
Nottingham, United Kingdom, N65 1PB
Pfizer Investigational Site
Tyne and Wear, United Kingdom, NE7 7DN
Pfizer Investigational Site
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Pfizer
UCB, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01232556     History of Changes
Other Study ID Numbers: B1931008, 3129K5-3303
Study First Received: October 27, 2010
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
inotuzumab ozogamicin
aggressive Non-Hodgkin lymphoma
diffuse large b-cell lymphoma
relapsed/refractory lymphoma

Additional relevant MeSH terms:
Aggression
Lymphoma
Lymphoma, Non-Hodgkin
Behavioral Symptoms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Bendamustine
Rituximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014