Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL)

This study has been completed.
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00299494
First received: March 2, 2006
Last updated: August 10, 2015
Last verified: August 2015
  Purpose

The purpose of the study is to determine the tolerability, the initial safety profile and maximum tolerated dose, and to obtain preliminary information on the antitumor activity of inotuzumab ozogamicin [CMC-544] in combination with rituximab in subjects with follicular, diffuse large B-Cell, or mantle cell NHL.


Condition Intervention Phase
B-Cell Lymphoma
Drug: inotuzumab ozogamicin
Drug: Rituximab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study Of CMC-544 Administered In Combination With Rituximab In Subjects With Follicular Or Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Determination of MTD and safety as measured by the incidence of AEs [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Progression free survival at 6 months [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Overall survival data [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic and pharmacodynamic measures of inotuzumab ozogamicin given in combination with rituximab [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 119
Study Start Date: May 2006
Study Completion Date: June 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Follicular
Drug: inotuzumab ozogamicin
IV, 1.8 mg/m2, q4w
Other Name: CMC-544
Drug: Rituximab
rituximab 375 mg/m^2 via IV infusion on Day 1
Experimental: 2
Diffuse Large B-cell Lymphoma
Drug: inotuzumab ozogamicin
IV, 1.8 mg/m2, q4w
Other Name: CMC-544
Drug: Rituximab
rituximab 375 mg/m^2 via IV infusion on Day 1
Experimental: 3
Refractory Aggressive NHL
Drug: inotuzumab ozogamicin
IV, 1.8 mg/m2, q4w
Other Name: CMC-544
Drug: Rituximab
rituximab 375 mg/m^2 via IV infusion on Day 1

  Eligibility

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

Inclusion Criteria:

  • Subjects with CD20 and CD22-positive, follicular or diffuse large B-cell NHL who have not responded or progressed after 1 or 2 prior therapies; or subjects with CD20 and CD22-positive intermediate/aggressive NHL (diffuse large B-cell, mantle cell, transformed follicular or follicular grade 3b NHL) who have not responded or progressed after 1 or more prior therapies and are refractory to a previous rituximab containing therapy.
  • Prior therapy must contain at least one course of rituximab therapy, as single agent or in combination.
  • Measurable disease.

Exclusion Criteria:

  • Subjects who are candidates for other potentially curative therapies.
  • Subjects must not have received previous radioimmunotherapy.
  • Subjects who have undergone a prior bone marrow transplantation within the last 6 months.
  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: NCT00299494

  Hide Study Locations
Locations
United States, Alabama
IDS Pharmacy
Birmingham, Alabama, United States, 35249
University of Alabama at Birmingham-
Birmingham, Alabama, United States, 35249 - 3300
University of Alabama at Birmingham-
Birmingham, Alabama, United States, 35294
United States, California
California Cancer Care, Inc.
Greenbrae, California, United States, 94904
University of California Medical Center
San Francisco, California, United States, 94143
California Cancer Care
San Mateo, California, United States, 94402
United States, Georgia
Emory Clinic
Atlanta, Georgia, United States, 30322
Emory University Hospital
Atlanta, Georgia, United States, 30322
Emory University Investigational Drug Service
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611
United States, Nevada
Nevada Cancer Institute-
Las Vegas, Nevada, United States, 89135
United States, New York
Rosewell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Cleveland Clinic
Cleveland, Ohio, United States, 44195
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Gabrail Cancer Center
Dover, Ohio, United States, 44622
UHHS - Westlake
Westlake, Ohio, United States, 44145
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Australia
Royal Brisbane and Women's Hospital
Herston, Australia, 4029
Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Vlaams-Brabant, Belgium, 3000
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
University Hospital Gent - Department of Hematology
Gent, Belgium, 9000
France
Hôpital André MIGNOT
Le Chesnay, France, 78157
Hôpital Saint-Louis
Paris, France, 75010
CH Lyon Sud
Pierre Benite, France, 69495
Germany
Universitaetsklinik Bonn, Medizinische Klinik und Poliklinik III
Bonn, Germany, 53105
Universitaetsmedizin der Johannes Gutenberg-Universitaet, III. medizinische klinik und Poliklinik
Mainz, Germany, 55131
Hong Kong
Prince Of Wales Hospital
Shatin N.T., Hong Kong
Italy
Universita La Sapienza Cattedra di Ematologia
Roma, Italy, 00161
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Netherlands
Erasmus Medisch Centrum--
Rotterdam, Zuid-Holland, Netherlands, 3015 CE
Poland
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
Warszawa, Poland, 02-781
Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, Spain, 08028
Switzerland
University Hospital Zurich
Zurich, Switzerland, 8091
United Kingdom
Derriford Hospital - Plymouth
Plymouth, Devon, United Kingdom, PL6 8DH
Somers Cancer Science Building MP824
Southampton, Hampshire, United Kingdom, SO16 6YD
Bart's Cancer Institute; Queen Mary University of London
London, United Kingdom, EC1M 6BQ
Sponsors and Collaborators
Pfizer
UCB Pharma
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00299494     History of Changes
Other Study ID Numbers: 3129K3-101, B1931004, 2005-005436-27
Study First Received: March 2, 2006
Last Updated: August 10, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Lymphoma
NHL

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on September 03, 2015