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Cyclophosphamide and Filgrastim Followed By Stem Cell Transplant in Treating Patients With Chronic or Accelerated Phase Myelogenous Leukemia
This study has been terminated.
( Study terminated as principal investigator [PI] left the university. )
Study NCT00005984   Information provided by National Cancer Institute (NCI)
First Received: July 5, 2000   Last Updated: August 9, 2009   History of Changes

July 5, 2000
August 9, 2009
August 2000
 
  • Time to hemopoietic recovery after transplantation [ Designated as safety issue: No ]
  • Detection of the Philadelphia chromosome or the BCR/ABL gene abnormality in post-transplantation marrow samples [ Designated as safety issue: No ]
  • Time to hemopoietic recovery after transplantation
  • Detection of the Philadelphia chromosome or the BCR/ABL gene abnormality in post-transplantation marrow samples
Complete list of historical versions of study NCT00005984 on ClinicalTrials.gov Archive Site
  • Time to initial hospital discharge [ Designated as safety issue: No ]
  • Peritransplantation toxicity [ Designated as safety issue: Yes ]
  • Quality of life at various time points [ Designated as safety issue: No ]
  • Cause of death [ Designated as safety issue: No ]
  • Time to initial hospital discharge
  • Peritransplantation toxicity
  • Quality of life at various time points
  • Cause of death
 
Cyclophosphamide and Filgrastim Followed By Stem Cell Transplant in Treating Patients With Chronic or Accelerated Phase Myelogenous Leukemia
Autologous Marrow Transplantation for Chronic Myelogenous Leukemia Using Stem Cells Obtained After In Vivo Cyclophosphamide/G-CSF Priming

RATIONALE: Giving colony-stimulating factors, such as G-CSF, and cyclophosphamide helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy.

PURPOSE: This phase II trial is studying how well cyclophosphamide plus filgrastim followed by stem cell transplant works in treating patients with chronic phase or accelerated phase chronic myelogenous leukemia.

OBJECTIVES:

  • Assess the clinical outcomes, survival, and morbidity of patients with chronic or accelerated phase chronic myelogenous leukemia when treated with cyclophosphamide and filgrastim (G-CSF) followed by autologous peripheral blood stem cell transplantation.
  • Determine whether priming with cyclophosphamide and filgrastim (G-CSF) increases the fraction of benign Philadelphia chromosome negative hematopoietic progenitors in peripheral blood stem cells (PBSC) and reduces the incidence of persistent or recurrent leukemia after autologous transplantation with mobilized PBSC in these patients.

OUTLINE: Patients receive priming therapy consisting of cyclophosphamide IV over 2 hours on day 1 and filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Peripheral blood stem cells (PBSC) are collected between days 14-21.

Patients then receive preparative therapy for transplant consisting of cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation twice a day on days -4 through -1. Patients receive the PBSC transplantation on day 0. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover. Patients then receive interferon alfa SQ daily in the absence of unacceptable toxicity or disease progression.

Patients are followed at 3 weeks; then at 3, 6, 9, 12, and 18 months; and then annually for 5 years.

PROJECTED ACCRUAL: Not specified

Phase II
Interventional
Treatment
Leukemia
  • Drug: cyclophosphamide
  • Drug: filgrastim
  • Drug: recombinant interferon alfa
  • Procedure: peripheral blood stem cell transplantation
  • Procedure: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed chronic or accelerated phase chronic myelogenous leukemia (CML)

    • Philadelphia chromosome positive OR
    • BCR/ABL rearrangement
  • No blast crisis or post blast crisis
  • No severe fibrosis defined by bilateral trephine biopsies
  • No splenomegaly (below umbilicus) that does not respond to chemotherapy and/or radiotherapy
  • Ineligible or refused to participate in ongoing allogeneic marrow donor transplant protocols

PATIENT CHARACTERISTICS:

Age:

  • 70 and under

Performance status:

  • Age 65-70 years:

    • Karnofsky 80-100%
  • Under 65 years:

    • Karnofsky 90-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Age 65-70 years:

    • Creatinine clearance greater than 60 mL/min (if creatinine at least 1.5 mg/dL)
  • Under 65 years:

    • Not specified

Cardiovascular:

  • Age 65-70 years:

    • LVEF at least 45%

Pulmonary:

  • Age 65-70 years:

    • If history of smoking or respiratory symptoms, spirometry and DLCO must be greater then 50% of predicted

Other:

  • Normal organ function (excluding bone marrow)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • Not specified
Both
up to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005984
 
CDR0000067972, UMN-MT-9611, UMN-MT-1996-11
Masonic Cancer Center, University of Minnesota
 
Study Chair: Catherine M. Verfaillie, MD Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)
April 2006

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