A Phase I, Open Label Study to Evaluate the Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma
- 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
- 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
- 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.
- 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.