Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma

Biogen

Status and phase

Terminated

Phase 1

Conditions

Lymphoma, Non-Hodgkin's

Treatments

Drug: Galiximab

Study type

Interventional

Funder types

Industry

Identifiers

114-NH-103

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.