G-CSF in Stimulating Peripheral Stem Cells for Autologous Stem Cell Transplant in Treating Patients With Chronic Phase Chronic Myeloid Leukemia in Complete Remission
|ClinicalTrials.gov Identifier: NCT00233961|
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : February 4, 2013
RATIONALE: Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored until transplant.
PURPOSE: This phase I trial is studying the side effects of G-CSF in stimulating peripheral stem cells for autologous stem cell transplant in treating patients with chronic phase chronic myeloid leukemia in remission.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Biological: filgrastim||Phase 1|
- Determine the feasibility and safety of harvesting adequate numbers of CD34-positive peripheral blood stem cells using filgrastim (G-CSF) in patients with chronic phase chronic myeloid leukemia in complete cytogenetic remission.
- Determine the safety of temporarily discontinuing treatment with imatinib mesylate and using G-CSF during the harvesting procedure, in terms of the percentage of Philadelphia chromosome (Ph)-positive cells before and after stem cell harvest, in these patients.
OUTLINE: Patients receive filgrastim (G-CSF) and then undergo apheresis for up to 5 days.
After completion of apheresis, patients resume treatment with imatinib mesylate off study. Patients may later undergo autologous peripheral blood stem cell transplantation, when deemed necessary.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Masking:||None (Open Label)|
|Official Title:||Peripheral Blood Stem Cell Mobilization With Filgrastim in Patients With Chronic Myeloid Leukemia in Cytogenetic Response|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||January 2008|
- Feasibility and safety of harvesting chronic myeloid leukemia (CML) patients in continuous complete remission (CCR) by adequate CD34+ stem cell numbers post-harvest
- Effect of discontinuation of imatinib during harvesting by cytogenetic evaluation post-harvest
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): NCT00233961
|United States, New York|
|Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center|
|New York, New York, United States, 10032|
|Study Chair:||Gwen L. Nichols, MD||Herbert Irving Comprehensive Cancer Center|