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

Biogen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: IDEC-114

Study type: Interventional

Funder types: Industry

Identifiers

NCT00048555

114-21

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

1

Experimental group

Treatment:

Drug: IDEC-114