Status:
COMPLETED
G-CSF in Stimulating Peripheral Stem Cells for Autologous Stem Cell Transplant in Treating Patients With Chronic Phase Chronic Myeloid Leukemia in Complete Remission
Lead Sponsor:
Herbert Irving Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
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 ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of chronic phase chronic myeloid leukemia
- In complete cytogenetic remission, confirmed by bone marrow biopsy within the past month
- Has been receiving imatinib mesylate for ≥ 3 months\* NOTE: \*Imatinib mesylate is held during the study harvesting procedure
- No myelofibrosis on bone marrow ≥ 3+
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00233961
Start Date
January 1 2005
End Date
January 1 2008
Last Update
February 4 2013
Active Locations (1)
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1
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032