Interferon Alfa Plus Sargramostim in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous 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: NCT00003561|
Recruitment Status : Terminated
First Posted : March 22, 2004
Last Update Posted : July 20, 2011
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of therapy. Combining sargramostim with interferon alfa may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of sargramostim in treating patients who are receiving interferon alfa for chronic phase chronic myelogenous leukemia that is in remission.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Biological: recombinant interferon alfa Biological: sargramostim||Phase 2|
OBJECTIVES: I. Estimate the rate of major cytogenetic responses to sargramostim (GM-CSF) and interferon alfa in patients with newly diagnosed chronic phase chronic myeloid leukemia. II. Estimate the dosing, schedule, and toxic effects of GM-CSF plus interferon alfa in these patients.
OUTLINE: All patients are in hematologic remission on subcutaneous interferon alfa upon entering the study. Once a complete hematologic response is achieved and the interferon alfa dose has been stable for 14 days, patients receive subcutaneous sargramostim (GM-CSF) daily for 6 months. Patients are followed at 3, 6, 9, and 12 months.
PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Official Title:||Granulocyte-Macrophage Colony Stimulating Factor (Rhu-GM-CSF) With Interferon-Alpha (IFN-alpha) for Chronic Myeloid Leukemia|
|Study Start Date :||February 1998|
|Actual Primary Completion Date :||October 2001|
|Actual Study Completion Date :||August 2010|
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): NCT00003561
|United States, Maryland|
|Johns Hopkins Oncology Center|
|Baltimore, Maryland, United States, 21231-2410|
|Study Chair:||Richard J. Jones, MD||Sidney Kimmel Comprehensive Cancer Center|