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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.
 
ClinicalTrials.gov Identifier: NCT00233961
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : February 4, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE October 5, 2005
First Posted Date  ICMJE October 6, 2005
Last Update Posted Date February 4, 2013
Study Start Date  ICMJE January 2005
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
Feasibility and safety of harvesting chronic myeloid leukemia (CML) patients in continuous complete remission (CCR) by adequate CD34+ stem cell numbers post-harvest
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00233961 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
Effect of discontinuation of imatinib during harvesting by cytogenetic evaluation post-harvest
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE Peripheral Blood Stem Cell Mobilization With Filgrastim in Patients With Chronic Myeloid Leukemia in Cytogenetic Response
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Leukemia
Intervention  ICMJE Biological: filgrastim
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)
20
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00233961
Other Study ID Numbers  ICMJE CDR0000441128
CPMC-AAAA9963
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Herbert Irving Comprehensive Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Gwen L. Nichols, MD Herbert Irving Comprehensive Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP