Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00233961
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
2005-10-05
Brief Title:
G-CSF in Stimulating Peripheral Stem Cells for Autologous Stem Cell Transplant in Treating Patients With Chronic Phase Chronic Myeloid Leukemia in Complete Remission
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Peripheral Blood Stem Cell Mobilization With Filgrastim in Patients With Chronic Myeloid Leukemia in Cytogenetic Response
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CPMC-AAAA9963 | None | None | None |