Autologous Transplantation for Chronic Myelogenous Leukemia Using Retrovirally Marked Peripheral Blood Progenitor Cells Obtained After In Vivo Cyclophosphamide/G-CSF Priming
Autologous Transplantation for Chronic Myelogenous Leukemia Using Retrovirally Marked Peripheral Blood Progenitor Cells Obtained After In Vivo Cyclophosphamide/G-CSF Priming
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy and filgrastim followed by peripheral stem cell transplantation in treating patients who have chronic myelogenous leukemia.
OBJECTIVES:
OUTLINE: In the priming phase, patients receive cyclophosphamide IV over 2 hours on day 1 and filgrastim (G-CSF) subcutaneously (SQ) daily beginning on day 4 and continuing until the completion of leukapheresis. Peripheral blood stem cells (PBSC) are harvested 4-7 times between days 10 and 21 beginning when blood counts recover (CD34+ cells are selected from 2 of these PBSC collections and transduced with the LN NEO virus prior to cryopreservation).
In the transplant phase, patients who have not received prior radiotherapy receive cyclophosphamide IV over 2 hours daily on days -7 and -6 and total body irradiation on days -4 through -1. Autologous PBSC and LN NEO transduced CD34+ cells are reinfused on day 0. Patients also receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover.
Patients who have received prior radiotherapy receive oral busulfan every 6 hours on days -10 through -7 and cyclophosphamide IV daily on days -6 through -3. Autologous PBSC and LN NEO transduced CD34+ cells are reinfused on day 0. Patients also receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover.
All patients then receive interferon alfa SQ daily until disease progression or unacceptable toxicity.
Patients are followed at 3 weeks; at 3, 6, 9, 12, 18, and 24 months; and then annually thereafter.
PROJECTED ACCRUAL: A total of 4-26 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
Histologically confirmed chronic or accelerated phase chronic myelogenous leukemia
No blast crisis or post blast crisis
No moderate to severe fibrosis defined by bilateral trephine biopsies
Not eligible for or refused to participate in allogeneic marrow transplant protocols
No splenomegaly (below umbilicus) that does not respond to chemotherapy and/or radiotherapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery: