Cyclophosphamide and Filgrastim Followed By SCT in Patients With Chronic or Accelerated Phase Myelogenous Leukemia

This study has been terminated.
(Study terminated as principal investigator [PI] left the university.)
Sponsor:
Information provided by:
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00005984
First received: July 5, 2000
Last updated: May 25, 2011
Last verified: May 2011

July 5, 2000
May 25, 2011
August 2000
September 2005   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
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 ]
Not Provided
Not Provided
Not Provided
 
Cyclophosphamide and Filgrastim Followed By SCT in 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

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia
  • Drug: cyclophosphamide
    intravenously over 2 hours on day 1 and on days -7 and -6
    Other Names:
    • Endoxan
    • Cytoxan
  • Drug: filgrastim
    filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover
    Other Name: NEUPOGEN®
  • Drug: recombinant interferon alfa
    Beginning on Day 1, subcutaneous (SQ) daily administration in the absence of unacceptable toxicity or disease progression
    Other Name: INTRON® A
  • Procedure: peripheral blood stem cell transplantation
    Patients receive the PBSC transplantation on day 0.
    Other Name: bone marrow transplant
  • Procedure: radiation therapy
    total body irradiation twice a day on days -4 through -1
    Other Name: irradiation
Experimental: Patients with CML
Patients treated for chronic accelerated phase and/or chronic myelogenous leukemia (CML)
Interventions:
  • Drug: cyclophosphamide
  • Drug: filgrastim
  • Drug: recombinant interferon alfa
  • Procedure: peripheral blood stem cell transplantation
  • Procedure: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
22
September 2005
September 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

    • Philadelphia chromosome positive OR
    • BCR/ABL rearrangement
  • Ineligible or refused to participate in ongoing allogeneic marrow donor transplant protocols
  • 70 and under
  • Performance status:

    • Age 65-70 years:
    • Karnofsky 80-100%
    • Under 65 years:
    • Karnofsky 90-100%
  • 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
  • Normal organ function (excluding bone marrow)

Exclusion Criteria:

  • Blast crisis or post blast crisis
  • Severe fibrosis defined by bilateral trephine biopsies
  • Splenomegaly (below umbilicus) that does not respond to chemotherapy and/or radiotherapy
Both
up to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005984
1996LS183, UMN-MT-1996-11
Yes
Catherine Verfaille, MD, Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
Not Provided
Study Chair: Catherine M. Verfaillie, MD Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
May 2011

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