A Phase I/II Trial of IDEC-114 (Anti-CD80 Monoclonal Antibody) in Combination With Rituxan® for Patients With Relapsed or Refractory, Follicular Lymphoma
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma
Both
Non-Hodgkin's Lymphoma
Trial Information
A Phase I/II Trial of IDEC-114 (Anti-CD80 Monoclonal Antibody) in Combination With Rituxan® for Patients With Relapsed or Refractory, Follicular Lymphoma
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To characterize the safety profile and to define the dose of galiximab to be used for the Phase II portion of the study
Outcome Time Frame:
March 2010
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
114-21
NCT ID:
NCT00048555
Start Date:
November 2002
Completion Date:
November 2010
Related Keywords:
- Non-Hodgkin's Lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Research Site | Alabaster, Alabama |
| Research Site | Mesa, Arizona |
| Research Site | Anaheim, California |
| Research Site | Boulder, Colorado |
| Research Site | Washington, District of Columbia |
| Research Site | Boca Raton, Florida |
| Research Site | Arlington Heights, Illinois |
| Research Site | Beverly, Massachusetts |
| Research Site | Battle Kreek, Michigan |
| Research Site | Alexandria, Minnesota |
| Research Site | Grand Island, Nebraska |
| Research Site | Albany, New York |
| Research Site | Asheville, North Carolina |
| Research Site | Allentown, Pennsylvania |
| Research Site | Charleston, South Carolina |
| Research Site | Abilene, Texas |
| Research Site | Abington, Virginia |
