Expired Study
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Buffalo, New York 14263


Purpose:

The purpose of the study is to evaluate the mechanism(s) of action of galiximab in subjects with previously untreated follicular NHL.


Criteria:

Inclusion Criteria: - 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 Criteria: - 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.


NCT ID:

NCT00651443


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14263
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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