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
1 other identifier
interventional
42
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2002
Longer than P75 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
December 13, 2007
CompletedFirst Posted
Study publicly available on registry
December 17, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedJune 8, 2012
January 1, 2011
8 months
December 13, 2007
June 7, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
To characterize the safety profile of IDEC-114 and to define their duration and reversibility
March 2010
Secondary Outcomes (4)
To evaluate PK
March 2010
To monitor presence of human anti galiximab antibody
March 2010
To evaluate efficacy
March 2010
To identify Nk functional assays that may predict galiximab efficacy
March 2010
Study Arms (1)
1
EXPERIMENTALInterventions
Phase 1-A Group 1 - 125 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-A Group 2 - 250 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-A Group 3 - 375 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-B Group 4 - 500 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase II-A \& II-B - Dosage start at the MTD (up to 375 mg/m2)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (4)
Research Site
Tucson, Arizona, 85724, United States
Research Site
Rochester, Minnesota, 55902, United States
Research Site
Buffalo, New York, 14263, United States
Research Site
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 13, 2007
First Posted
December 17, 2007
Study Start
January 1, 2002
Primary Completion
September 1, 2002
Study Completion
November 1, 2010
Last Updated
June 8, 2012
Record last verified: 2011-01