Trial Information

A PHASE III RANDOMIZED STUDY COMPARING G-CSF MOBILIZED PERIPHERAL BLOOD STEM CELLS WITH MARROW AS THE SOURCE OF STEM CELLS FOR ALLOGENEIC TRANSPLANTS FROM HLA IDENTICAL, RELATED DONORS FOR THE TREATMENT OF CHRONIC MYELOID LEUKEMIA

OBJECTIVES: I. Compare the incidence of persistent cytogenetic or hematologic relapse in
patients with chronic myeloid leukemia in chronic or accelerated phase treated with
transplantation using filgrastim (G-CSF)-mobilized peripheral blood stem cells vs bone
marrow from HLA-identical, related donors. II. Compare survival and nonrelapse mortality in
patients treated with these regimens. III. Compare incidence and severity of acute and
chronic graft versus host disease in patients treated with these regimens. IV. Compare
hospitalization and treatment associated expenses for patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
(15-39 vs 40-65), interval from diagnosis to transplantation (under 2 years vs 2 years or
more, and permutations of patient and donor gender. Patients are randomized to one of two
treatment arms. Arm I: Patients receive a preparative regimen comprising busulfan orally or
IV 4 times daily on days -7 to -4 and cyclophosphamide IV on days -3 and -2. Allogeneic
filgrastim (G-CSF)-mobilized peripheral blood stem cells are infused on day 0. Arm II:
Busulfan and cyclophosphamide are administered as in arm I. Allogeneic bone marrow is
infused on day 0. Patients receive graft-versus-host disease prophylaxis comprising
methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1-4 hours or orally every
12 hours on days -1 to 80 and then tapered. Patients are followed every 6 months for 2 years
and then annually thereafter.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.