Leukemia Clinical Trial
Official title:
ALLOGENEIC MARROW OR PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR AGNOGENIC MYELOID METAPLASIA WITH MYELOFIBROSIS
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining bone marrow or peripheral stem cell transplantation
with chemotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill
more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus either
bone marrow or peripheral stem cell transplantation in treating patients with
myeloproliferative disorders.
OBJECTIVES:
- Assess disease free survival in patients with idiopathic myelofibrosis treated with a
preparative busulfan/cyclophosphamide regimen followed by allogeneic bone marrow or
peripheral blood stem cell transplantation.
- Determine the risk of primary graft failure in these patients.
OUTLINE: Patients receive a preparative regimen consisting of oral busulfan every 6 hours on
days -7 through -4 and cyclophosphamide on days -3 and -2. Patients then receive allogeneic
bone marrow or peripheral blood stem cells on day 0. Patients registered on protocol
FHCRC-1106.00 randomized to stem cell transplant receive unmodified G-CSF-mobilized stem
cells from an HLA-identical donor.
Patients receive cyclosporine/methotrexate or tacrolimus/methotrexate as prophylaxis for
graft-versus-host disease (GVHD). Patients receiving marrow from unrelated donors are
eligible for appropriate GVHD prophylaxis studies.
Patients are followed at 6 and 12 months after transplant.
PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for this study over
approximately 3.5 years.
;
Primary Purpose: Treatment
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