Back to resultsG-CSF in Stimulating Peripheral Stem Cells for Autologous Stem Cell Transplant in Treating Patients With Chronic Phase Chronic Myeloid Leukemia in Complete Remission
Primary Purpose
Leukemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
filgrastim
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring chronic phase chronic myelogenous leukemia
Eligibility 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
Sites / Locations
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
Outcomes
Primary Outcome Measures
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
Effect of discontinuation of imatinib during harvesting by cytogenetic evaluation post-harvest
Full Information
NCT ID
NCT00233961
First Posted
October 5, 2005
Last Updated
February 1, 2013
Sponsor
Herbert Irving Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00233961
Brief Title
G-CSF in Stimulating Peripheral Stem Cells for Autologous Stem Cell Transplant in Treating Patients With Chronic Phase Chronic Myeloid Leukemia in Complete Remission
Official Title
Peripheral Blood Stem Cell Mobilization With Filgrastim in Patients With Chronic Myeloid Leukemia in Cytogenetic Response
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Herbert Irving Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
chronic phase chronic myelogenous leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
filgrastim
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Effect of discontinuation of imatinib during harvesting by cytogenetic evaluation post-harvest
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwen L. Nichols, MD
Organizational Affiliation
Herbert Irving Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Learn more about this trial
G-CSF in Stimulating Peripheral Stem Cells for Autologous Stem Cell Transplant in Treating Patients With Chronic Phase Chronic Myeloid Leukemia in Complete Remission
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