G-CSF in Stimulating Peripheral Stem Cells for Autologous Stem Cell Transplant in Treating Patients With Chronic Phase Chronic Myeloid Leukemia in Complete Remission

Herbert Irving Comprehensive Cancer Center20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leukemia

Interventions

filgrastimBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Feasibility and safety of harvesting chronic myeloid leukemia (CML) patients in continuous complete remission (CCR) by adequate CD34+ stem cell numbers post-harvest

Secondary Outcomes

Effect of discontinuation of imatinib during harvesting by cytogenetic evaluation post-harvest

Data from ClinicalTrials.gov

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