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

Completed · Phase 2

Conditions studied: Lymphoma

In brief

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.

Key facts

Study ID

NCT01939730

Run by

M.D. Anderson Cancer Center

People needed

42

Starts

1999-08-01

Expected to finish

2013-09-01

Last updated by the study team

2015-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Males or females, 18 years or older; expected survival of =/> 4 months; performance status of 0, 1 or 2.
• Demonstrable monoclonal cluster of differentiation antigen 20 (CD20)-positive B-cell population.
• 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)

You may not qualify if…

• presence of Central Nervous System (CNS) Lymphoma
• chronic lymphocytic leukemia (CLL)
• small lymphocytic lymphoma
• therapy in prior 3 weeks (6 weeks for nitrosourea; 6 months for Bone Marrow Transplantation (BMT))
• patients who received prior rituximab or other anti-CD20 therapy
• serious non-malignant disease, or other malignancy
• active infection
• history of HIV infection
• i pregnancy

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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