Status:
TERMINATED
Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma
Lead Sponsor:
Biogen
Conditions:
Lymphoma, Non-Hodgkin's
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate the mechanism(s) of action of galiximab in subjects with previously untreated follicular NHL.
Eligibility Criteria
Inclusion
- Written informed consent (signed and dated).
- Age equal or greater than 18 at the time of consent.
- Histologically confirmed follicular NHL according to the Revised European American Lymphoma (REAL)/ World Health Organization (WHO) classification (from initial diagnosis) Grades 1,2, or 3a.
- At least 2 malignant lymph nodes of similar size (\>1 cm in minimal dimension) and location that are readily accessible for excisional biopsy at the time of study entry.
- Consent to 1 pretreatment and 1 post-treatment excisional biopsy of accessible tumor.
- Acceptable hematologic, hepatic, and renal function parameters.
- WHO Performance Status equal or less than 2.
- Subjects of reproductive potential must agree to follow accepted birth control methods.
Exclusion
- Presence of lymphoma in CNS.
- Previous systemic anticancer treatment for NHL (including but not limited to radiation, myeloablative, or investigational therapy).
- Concurrent treatment with systemic steroids within 14 days of Day 1.
- Evidence of transformed lymphoma.
- Presence of malignancies within 3 years of Study Day 1 (except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal or squamous cell skin cancer).
- History of HIV infection or AIDS.
- Serious nonmalignant disease.
- Pregnant.
- Inability to comply with study and follow-up procedures.
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00651443
Start Date
August 1 2008
End Date
December 1 2010
Last Update
January 7 2011
Active Locations (1)
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1
Research Site
Buffalo, New York, United States, 14263