Safety and Efficacy of IDEC-114 in Combination With Rituxan in the Treatment of Non-Hodgkin's Lymphoma
A Phase I/II Trial of IDEC-114 (Anti-CD80 Monoclonal Antibody) in Combination With Rituxan® for Patients With Relapsed or Refractory, Follicular Lymphoma
1 other identifier
interventional
90
1 country
22
Brief Summary
To determine what side effects and what clinical effect, if any, the administration of this investigational product, IDEC-114 in combination with Rituxan® \[Rituxan® as a single agent is approved by the United States Food and Drug Administration (FDA) to treat patients with relapsed or refractory follicular NHL\], has in this patient population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2002
Longer than P75 for phase_1
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2002
CompletedStudy Start
First participant enrolled
November 1, 2002
CompletedFirst Posted
Study publicly available on registry
November 5, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedSeptember 16, 2013
January 1, 2011
1.3 years
November 1, 2002
September 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
To characterize the safety profile and to define the dose of galiximab to be used for the Phase II portion of the study
March 2010
Secondary Outcomes (3)
To evaluate PK
March 2010
To evaluate efficacy
March 2010
To monitor for the presence of human anti galiximab antibody and human antichimeric antibody formation
March 2010
Study Arms (1)
1
EXPERIMENTALInterventions
Dose Group 1 - 125 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 2 - 250 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 3 - 375 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 4 - 500 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions
Eligibility Criteria
You may qualify if:
- Signed IRB-approved informed consent
- Greater than or equal to 18 years of age
- Proof of follicular lymphoma
- Progressive disease requiring treatment after at least 1 prior standard therapy
- Acceptable hematologic status, liver function, and renal function
- Patients of reproductive potential must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment
You may not qualify if:
- No response to prior Rituxan® or Rituxan®-containing regimen
- Presence of CLL or CNS lymphoma
- Known history of HIV infection or AIDS
- Prior diagnosis of aggressive NHL or mantle-cell lymphoma
- Serious nonmalignant disease
- Pregnant or currently breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (22)
Research site
Birmingham, Alabama, 35294, United States
Research site
Tucson, Arizona, 85724, United States
Research site
Los Angeles, California, 90095, United States
Research site
Newport Beach, California, 92658, United States
Research site
San Diego, California, 92121, United States
Research site
Aurora, Colorado, 80010, United States
Research site
Washington D.C., District of Columbia, 20007, United States
Research site
Tampa Bay, Florida, 33612, United States
Research site
Chicago, Illinois, 60611, United States
Research site
Maywood, Illinois, 60153, United States
Research site
Boston, Massachusetts, 2115, United States
Research site
Detroit, Michigan, 48202, United States
Research site
Rochester, Minnesota, 55905, United States
Research site
Omaha, Nebraska, 68198, United States
Research site
Buffalo, New York, 14263, United States
Research site
New York, New York, 10021, United States
Research site
Rochester, New York, 14642, United States
Research site
Durham, North Carolina, 27710, United States
Research site
Philadelphia, Pennsylvania, 1906, United States
Research site
Columbia, South Carolina, 29210, United States
Research site
Houston, Texas, 77030, United States
Research site
Charlottesville, Virginia, 22908, United States
Related Publications (1)
Leonard JP, Friedberg JW, Younes A, Fisher D, Gordon LI, Moore J, Czuczman M, Miller T, Stiff P, Cheson BD, Forero-Torres A, Chieffo N, McKinney B, Finucane D, Molina A. A phase I/II study of galiximab (an anti-CD80 monoclonal antibody) in combination with rituximab for relapsed or refractory, follicular lymphoma. Ann Oncol. 2007 Jul;18(7):1216-23. doi: 10.1093/annonc/mdm114. Epub 2007 Apr 29.
PMID: 17470451BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 1, 2002
First Posted
November 5, 2002
Study Start
November 1, 2002
Primary Completion
March 1, 2004
Study Completion
November 1, 2010
Last Updated
September 16, 2013
Record last verified: 2011-01