RATIONALE: Biological therapy may increase the number of immune cells found in bone marrow
and may help a person's immune system recover from the side effects of the chemotherapy used
in treating chronic myeloid leukemia. Bone marrow transplantation may be able to replace
immune cells that were destroyed by chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation,
chemotherapy, and biological therapy in treating patients who have chronic myeloid leukemia.
OBJECTIVES: I. Determine the one year event-free survival in patients with chronic phase
chronic myeloid leukemia receiving sargramostim (GM-CSF)-treated autologous bone marrow
transplantation followed by GM-CSF and interferon alfa. II. Determine the toxicity of this
regimen in these patients.
OUTLINE: Patients undergo harvesting of autologous bone marrow. A portion of the cells are
treated ex vivo with sargramostim (GM-CSF) for 3 days. Patients then receive myeloablative
chemotherapy with busulfan and cyclophosphamide on days -9 to -2 according to the
preparative regimen protocol. Patients undergo sargramostim (GM-CSF)-treated autologous bone
marrow transplantation on day 0. Patients receive GM-CSF subcutaneously daily on days 5-180,
and interferon alfa daily on days 90-180. Patients are followed monthly for 1 year, every 6
months for 2 years, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 9-19 patients will be accrued for this study within 2-3 years.
DISEASE CHARACTERISTICS: Diagnosis of chronic phase chronic myeloid leukemia (CML) by
cytogenetic and/or molecular analyses No more than 10% blasts on blood and bone marrow
morphology Philadelphia (Ph) chromosome positive Ph chromosome-negative CML allowed if
evidence of the BCR-ABL rearrangement by molecular or FISH analyses or evidence of the
P120 protein Duration of CML less than 3 years, unless cytogenetic remission to interferon
has been achieved Failed to obtain and maintain a complete cytogenetic remission on a
prior trial of interferon therapy Absence of detectable PH-negative cells in bone marrow
or blood after 6 months of therapy Lack of a progressive increase in Ph-negative cells
between 6 and 12 months of therapy Less than 50% Ph-negative cells after 12 months of
therapy Absence of complete cytogenetic remission after 24 months of therapy Inability to
tolerate prior interferon therapy No accelerated phase or blast crisis CML, chronic
myelomonocytic leukemia, or juvenile CML Concurrent enrollment on the busulfan and
cyclophosphamide preparative regimen protocol
PATIENT CHARACTERISTICS: Age: 12 to 70 Performance status: Not specified Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Other: No history of intolerance to sargramostim (GM-CSF)
PRIOR CONCURRENT THERAPY: See Disease Characteristics