Study Evaluating 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 8, 2014
Last verified: August 2014
  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 CMC-544 in combination with rituximab in subjects with follicular, diffuse large B-Cell, or mantle cell NHL.


Condition Intervention Phase
Lymphoma, B-Cell
Drug: inotuzumab ozogamicin
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: 118
Study Start Date: May 2006
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Follicular
Drug: inotuzumab ozogamicin
iv, 1.8 mg/m2, q4w
Experimental: 2
Diffuse Large B-cell Lymphoma
Drug: inotuzumab ozogamicin
iv, 1.8 mg/m2, q4w
Experimental: 3
Refractory Aggressive NHL
Drug: inotuzumab ozogamicin
iv, 1.8 mg/m2, q4w

  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
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294-3300
United States, California
Pfizer Investigational Site
Greenbrae, California, United States, 94904
Pfizer Investigational Site
San Francisco, California, United States, 94143
Pfizer Investigational Site
San Mateo, California, United States, 94402
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30322
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60611
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89135
United States, New York
Pfizer Investigational Site
Buffalo, New York, United States, 14263
United States, Ohio
Pfizer Investigational Site
Canton, Ohio, United States, 44718
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
Pfizer Investigational Site
Dover, Ohio, United States, 44622
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030-4009
Australia, Queensland
Pfizer Investigational Site
Herston, Queensland, Australia, 4029
Australia
Pfizer Investigational Site
Herston, Australia, 4029
Belgium
Pfizer Investigational Site
Leuven, Vlaams-Brabant, Belgium, 3000
Pfizer Investigational Site
Gent, Belgium, 9000
France
Pfizer Investigational Site
Le Chesnay, France, 78157
Pfizer Investigational Site
Paris, France, 75010
Pfizer Investigational Site
Pierre-Benite Cedex, France, 69495
Germany
Pfizer Investigational Site
Bonn, Germany, 53105
Pfizer Investigational Site
Mainz, Germany, 55131
Hong Kong
Pfizer Investigational Site
Shatin, Hong Kong
Italy
Pfizer Investigational Site
Roma, Italy, 00161
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Netherlands
Pfizer Investigational Site
Rotterdam, Zuid-Holland, Netherlands, 3075 EA
Pfizer Investigational Site
Rotterdam, Zuid-Holland, Netherlands, 3015 CE
Pfizer Investigational Site
Rotterdam, Netherlands, 3015 GD
Poland
Pfizer Investigational Site
Warszawa, Poland, 02-781
Spain
Pfizer Investigational Site
Barcelona, Spain, 08036
Switzerland
Pfizer Investigational Site
Zurich, Switzerland, 8091
Pfizer Investigational Site
Zurich, Switzerland
United Kingdom
Pfizer Investigational Site
Plymouth, Devon, United Kingdom, PL6 8DH
Pfizer Investigational Site
Southampton, Hampshire, United Kingdom, SO16 6YD
Pfizer Investigational Site
Southampton, Hants, United Kingdom, SO16 6YD
Pfizer Investigational Site
London, United Kingdom, EC1A 7BE
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
Study First Received: March 2, 2006
Last Updated: August 8, 2014
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

ClinicalTrials.gov processed this record on October 21, 2014