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 Center

Status and phase: Completed; Phase 1

Conditions: Leukemia

Treatments: Biological: filgrastim

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00233961

CDR0000441128

CPMC-AAAA9963

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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