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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00233961

Enrollment

Registered

2005-10-06

Start date

2005-01-31

Completion date

2008-01-31

Last updated

2013-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

chronic phase chronic myelogenous leukemia

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.

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.

Interventions

BIOLOGICALfilgrastim

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Effect of discontinuation of imatinib during harvesting by cytogenetic evaluation post-harvest	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026