G-CSF in Stimulating Peripheral Stem Cells for Autologous Stem Cell Transplant in Treating Patients With Chronic Phase Chronic Myeloid Leukemia in Complete Remission
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
OBJECTIVES:
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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.
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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 Design
Outcome Measures
Primary Outcome Measures
- Feasibility and safety of harvesting chronic myeloid leukemia (CML) patients in continuous complete remission (CCR) by adequate CD34+ stem cell numbers post-harvest []
Secondary Outcome Measures
- Effect of discontinuation of imatinib during harvesting by cytogenetic evaluation post-harvest []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Diagnosis of chronic phase chronic myeloid leukemia
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In complete cytogenetic remission, confirmed by bone marrow biopsy within the past month
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Has been receiving imatinib mesylate for ≥ 3 months* NOTE: *Imatinib mesylate is held during the study harvesting procedure
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No myelofibrosis on bone marrow ≥ 3+
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Ineligible for or refused allogeneic stem cell transplantation
PATIENT CHARACTERISTICS:
Age
- Over 18
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
-
WBC > 3,000/mm^3
-
Platelet count > 100,000/mm^3
Hepatic
- Adequate hepatic function for stem cell transplantation
Renal
- Adequate renal function for stem cell transplantation
Cardiovascular
- Adequate cardiovascular function for stem cell transplantation
Pulmonary
- Adequate pulmonary function for stem cell transplantation
Other
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No other concurrent biologic therapy
Chemotherapy
-
More than 4 weeks since prior chemotherapy
-
No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No concurrent radiotherapy
Surgery
- No concurrent surgery
Other
- No other concurrent experimental therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Herbert Irving Comprehensive Cancer Center
- National Cancer Institute (NCI)
Investigators
- Study Chair: Gwen L. Nichols, MD, Herbert Irving Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000441128
- CPMC-AAAA9963