Leukemia Clinical Trial
Official title:
AUTOLOGOUS BONE MARROW TRANSPLANTATION USING C-MYB (LR-3001) ANTISENSE OLIGODEOXYNUCLEOTIDE TREATED BONE MARROW IN CHRONIC MYELOGENOUS LEUKEMIA IN CHRONIC OR ACCELERATED PHASE
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining chemotherapy with autologous bone marrow
transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill
more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by autologous
bone marrow transplantation in treating patients with chronic myelogenous leukemia.
OBJECTIVES: I. Evaluate the ability of c-myb antisense oligodeoxynucleotide to purge bone
marrow cells of clonogenic chronic myelogenous leukemia tumor cells and repopulate the bone
marrow with normal stem cells in patients treated with high-dose busulfan and
cyclophosphamide followed by autologous bone marrow transplantation using marrow treated
with c-myb antisense oligodeoxynucleotide. II. Determine the response rate, degree of
hematopoietic reconstitution, overall survival, and relapse-free survival of patients
treated with this regimen. III. Determine the toxicity of this regimen in these patients.
OUTLINE: Patients undergo bone marrow harvest. The bone marrow is treated with c-myb
antisense oligodeoxynucleotide and cryopreserved. A portion of the marrow is cryopreserved
untreated in case of engraftment failure. Patients receive oral busulfan every 6 hours on
days -7 to -4 for a total of 16 doses. Patients receive cyclophosphamide IV over 1 hour on
days -3 and -2. Bone marrow is reinfused on day 0. Patients receive filgrastim (G-CSF)
subcutaneously daily beginning on day 0 and continuing until blood counts recover. Patients
are followed every 2-3 months for 2 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 18-24
months.
;
Primary Purpose: Treatment
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