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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00233961
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : February 4, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Leukemia Biological: filgrastim Phase 1

Detailed Description:


  • 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  (Clinical Trial)
Estimated Enrollment : 20 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peripheral Blood Stem Cell Mobilization With Filgrastim in Patients With Chronic Myeloid Leukemia in Cytogenetic Response
Study Start Date : January 2005
Primary Completion Date : November 2007
Study Completion Date : January 2008

Primary Outcome Measures :
  1. 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 :
  1. Effect of discontinuation of imatinib during harvesting by cytogenetic evaluation post-harvest

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Over 18

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


  • WBC > 3,000/mm^3
  • Platelet count > 100,000/mm^3


  • Adequate hepatic function for stem cell transplantation


  • Adequate renal function for stem cell transplantation


  • Adequate cardiovascular function for stem cell transplantation


  • Adequate pulmonary function for stem cell transplantation


  • HIV negative


Biologic therapy

  • No other concurrent biologic therapy


  • More than 4 weeks since prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified


  • No concurrent radiotherapy


  • No concurrent surgery


  • No other concurrent experimental therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00233961

United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Gwen L. Nichols, MD Herbert Irving Comprehensive Cancer Center Identifier: NCT00233961     History of Changes
Other Study ID Numbers: CDR0000441128
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: January 2008

Keywords provided by National Cancer Institute (NCI):
chronic phase chronic myelogenous leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs