Safety and Efficacy of IDEC-114 in Combination With Rituxan in the Treatment of Non-Hodgkin's Lymphoma
Phase 1
Completed
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Drug: IDEC-114
- Registration Number
- NCT00048555
- Lead Sponsor
- Biogen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 IDEC-114 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research site
🇺🇸Charlottesville, Virginia, United States