Lymphoma, Non-Hodgkin's
Conditions
Keywords
galiximab, Untreated NHL, antibody, open-label
Brief summary
The purpose of the study is to evaluate the mechanism(s) of action of galiximab in subjects with previously untreated follicular NHL.
Interventions
DRUGGaliximab
Galiximab 500 mg/m2 IV once weekly times 4, followed by Galiximab 500 mg/m2 IV once monthly times 4 as an extended dosing regimen.
Sponsors
Biogen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL. | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| 1) Safety and tolerability of Galiximab when administered as a single agent in an extended dosing regimen in previously untreated subjects with follicular NHL. 2) Evaluation of preliminary clinical activity of galiximab. | 48 months |
Countries
United States
Outcome results
None listed