Clinical trial · Interventional
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
NCT00048555CI-TRIAL-00012069completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IDEC-114 | Drug | Galiximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: IDEC-114
Primary outcomes (1)
- measure
- To characterize the safety profile and to define the dose of galiximab to be used for the Phase II portion of the study
- timeFrame
- March 2010
Secondary outcomes (3)
- measure
- To evaluate PK
- timeFrame
- March 2010
- measure
- To evaluate efficacy
- timeFrame
- March 2010
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDLeonard JP, Friedberg JW, Younes A, Fisher D, Gordon LI, Moore J, Czuczman M, Miller T, Stiff P, Cheson BD, Forero-Torres A, Chieffo N, McKinney B, Finucane D, Molina A. A phase I/II study of galiximab (an anti-CD80 monoclonal antibody) in combination with rituximab for relapsed or refractory, follicular lymphoma. Ann Oncol. 2007 Jul;18(7):1216-23. doi: 10.1093/annonc/mdm114. Epub 2007 Apr 29. PMID 17470451