Rituximab and GM-CSF in Treating Patients With Chronic Lymphocytic Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00265915|
Recruitment Status : Terminated
First Posted : December 15, 2005
Last Update Posted : August 12, 2014
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with GM-CSF may be an effective treatment for chronic lymphocytic leukemia.
PURPOSE: This phase II trial is studying how well giving rituximab together with GM-CSF works in treating patients with B-cell chronic lymphocytic leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Biological: rituximab Biological: sargramostim||Phase 2|
- Determine the complete and overall response rate in patients with B-cell chronic lymphocytic leukemia treated with rituximab and sargramostim (GM-CSF).
- Determine the time to progression in patients treated with this regimen.
- Determine the effects of this regimen on CD20 antigen expression and soluble CD20 levels in these patients.
OUTLINE: This is a parallel-group, multicenter study. Patients are stratified according to disease status
Patients receive rituximab IV on days 4, 11, 18, and 25 and sargramostim (GM-CSF) subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, 40, 43, 45, 47, 50, 52, and 54 (course 1). Patients with responding disease may receive an additional course of treatment.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A CRC Trial of Rituximab in Combination With Sargramostim (GM-CSF) in Patients With Chronic Lymphocytic Leukemia|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||March 2006|
- Overall response rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00265915
|Study Chair:||Ian W. Flinn, MD, PhD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|