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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00048555

Enrollment

Registered

2002-11-05

Start date

2002-11-30

Completion date

2010-11-30

Last updated

2013-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin's Lymphoma

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.

Interventions

DRUGIDEC-114

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026