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 Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Peripheral Blood Stem Cell Mobilization With Filgrastim in Patients With Chronic Myeloid Leukemia in Cytogenetic Response

Conditions
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Leukemia

Intervention / Treatment
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* Biological: filgrastim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of discontinuation of imatinib during harvesting by cytogenetic evaluation post-harvest |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic phase chronic myelogenous leukemia