Cyclophosphamide and Filgrastim Followed By SCT in Patients With Chronic or Accelerated Phase Myelogenous Leukemia
| Status: | Terminated |
|---|---|
| Conditions: | Blood Cancer, Hematology, Leukemia |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | Any - 70 |
| Updated: | 12/1/2017 |
| Start Date: | August 2000 |
| End Date: | September 2005 |
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.
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
- 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
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
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