Rituximab + GM-CSF in Patients With Follicular B-Cell Lymphoma

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to see if using the drugs Rituximab (IDEC-C2B8) and Granulocyte-macrophage colony-stimulating factor (GM-CSF) (Leukine) together is better than using rituximab alone to treat follicular B-cell lymphomas. The safety of this treatment will also be studied.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Genentech, Inc.
• Treatments: Rituximab

Criteria

Inclusion Criteria:

1. Histologically confirmed follicular B-cell lymphoma. This can include relapsed patients, who have had no prior rituximab therapy, or previously untreated patients. Previously untreated patients should be made aware of higher priority protocols such as combination chemo-immunotherapy protocols, but if they decline that, they can be entered on this protocol.

2. Males or females, 18 years or older; expected survival of =/> 4 months; performance status of 0, 1 or 2.

3. Demonstrable monoclonal cluster of differentiation antigen 20 (CD20)-positive B-cell population.

4. Acceptable hematologic status including:

i. hemoglobin (Hgb) =/> 8.0 gm/dL

ii. White blood count (WBC) =/> 3.0 x 10^3/mm^3(x 10^9/L)

iii. Absolute granulocyte count =/> 1.5 x 10^3/mm^3

iv. Platelet count =/>75 x 10^3/mm^3

e. Adequate renal function (serum creatinine ≤ 2mg/dl)

Exclusion Criteria:

1. presence of Central Nervous System (CNS) Lymphoma

2. chronic lymphocytic leukemia (CLL)

3. small lymphocytic lymphoma

4. therapy in prior 3 weeks (6 weeks for nitrosourea; 6 months for Bone Marrow Transplantation (BMT))

5. patients who received prior rituximab or other anti-CD20 therapy

6. serious non-malignant disease, or other malignancy

7. active infection

8. history of HIV infection

i pregnancy