Safety and Efficacy of IDEC-114 in Combination With Rituxan in the Treatment of Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Galiximab; Rituximab

Criteria

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