Cyclophosphamide and Filgrastim Followed By SCT in Patients With Chronic or Accelerated Phase Myelogenous Leukemia
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.
Drug: recombinant interferon alfa
Procedure: peripheral blood stem cell transplantation
Procedure: radiation therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Autologous Marrow Transplantation for Chronic Myelogenous Leukemia Using Stem Cells Obtained After In Vivo Cyclophosphamide/G-CSF Priming|
- 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 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 ]
|Study Start Date:||August 2000|
|Study Completion Date:||September 2005|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
Experimental: Patients with CML
Patients treated for chronic accelerated phase and/or chronic myelogenous leukemia (CML)
intravenously over 2 hours on day 1 and on days -7 and -6
Other Names: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® AProcedure: peripheral blood stem cell transplantation
Patients receive the PBSC transplantation on day 0.
Other Name: bone marrow transplantProcedure: radiation therapy
total body irradiation twice a day on days -4 through -1
Other Name: irradiation
- 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
|United States, Minnesota|
|University of Minnesota Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|Study Chair:||Catherine M. Verfaillie, MD||Masonic Cancer Center, University of Minnesota|