Peripheral Blood Stem Cell Mobilization With Filgrastim in Patients With Chronic Myeloid Leukemia in Cytogenetic Response
18 Years
N/A
Both
Leukemia
Trial Information
Peripheral Blood Stem Cell Mobilization With Filgrastim in Patients With Chronic Myeloid Leukemia in Cytogenetic Response
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility and safety of harvesting chronic myeloid leukemia (CML) patients in continuous complete remission (CCR) by adequate CD34+ stem cell numbers post-harvest
Safety Issue:
Yes
Principal Investigator
Gwen L. Nichols, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Herbert Irving Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000441128
NCT ID:
NCT00233961
Start Date:
January 2005
Completion Date:
January 2008
Related Keywords:
- Leukemia
- chronic phase chronic myelogenous leukemia
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Leukemia, Myeloid, Chronic-Phase
Name | Location |
|---|---|
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York, New York 10032 |
