Clinical trial · Interventional
Safety and Efficacy of IDEC-114 in the Treatment of Non-Hodgkin's Lymphoma
A Phase I/II Trial of Anti-CD80 Monoclonal Antibody (IDEC-114) Therapy for Patients With Relapsed or Refractory Follicular Lymphoma
NCT00575068CI-TRIAL-00007133completedPhase 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)
The purpose of this study is to determine whether anti-CD80 monoclonal antibody (IDEC-114) is effective in the treatment of follicular B-cell non-Hodgkin's lymphoma. This drug has never been studied in patients with lymphoma, however, it has been studied in psoriasis patients at various dose levels and schedules.
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 of IDEC-114 and to define their duration and reversibility
- timeFrame
- March 2010
Secondary outcomes (4)
- measure
- To evaluate PK
- timeFrame
- March 2010
- measure
- To monitor presence of human anti galiximab antibody
- timeFrame
- March 2010
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed follicular lymphoma that has relapsed or has failed primary therapy * Progressive disease requiring further treatment * Bidimensionally measurable disease * Acceptable hematologic status * Prestudy WHO performance status of 0, 1, or 2 * Expected survival of \>/= 3 months * Patients with reproductive potential must follow accepted birth control methods during treatment and for 3 months after completion of treatment * Female patients must not be pregnant or lactating * Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, ABMT, or investigational drugs Exclusion Criteria: * Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks of first scheduled treatment (6 weeks if nitrosourea or mitomycin-C) * Prednisone or other immunosuppressive therapy within 3 weeks of first scheduled treatment * Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to first scheduled treatment * Previous exposure to IDEC-114 or any anti-CD80 antibody * ABMT within 6 months prior to first scheduled treatment * Abnormal liver function * Abnormal renal function * Presence of chronic lymphocytic leukemia (CLL) * Presence of CNS lymphoma * Presence of HIV infection or AIDS * Prior diagnosis of aggressive non-Hodgkin's lymphoma or mantle-cell lymphoma * Another primary malignancy (other than squamous cell and basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer with a stable PSA) for which the patient has not been disease-free for at least 3 years * Serious nonmalignant disease which would compromise protocol objectives in the opinion of the investigator and/or the sponsor * New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to first scheduled treatment * Major surgery, other than diagnostic surgery, within 4 weeks prior to first scheduled treatment * Pleural invasion and/or effusion with positive cytology for lymphoma * Peritoneal invasion and/or ascites with positive cytology for lymphoma
References
Publications (0)
Data not yet available
No reference posted for this study.