Leukemia Clinical Trial
Official title:
Phase II Study of High-Dose Busulfan and Cyclophosphamide Followed by Allogeneic Bone Marrow Transplantation for Patients With Acute Myelogenous Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining chemotherapy with donor 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 busulfan and cyclophosphamide followed
by bone marrow transplantation in treating patients who have acute myelogenous leukemia or
myelodysplastic syndrome.
OBJECTIVES:
- Determine the remission duration, disease-free survival, and overall survival of
patients with acute myelogenous leukemia in remission or early relapse or
myelodysplastic syndrome treated with high-dose busulfan and cyclophosphamide followed
by allogeneic bone marrow transplantation.
OUTLINE: Patients receive oral high-dose busulfan every 6 hours for 14-16 doses on days -9
to -6, followed by high-dose cyclophosphamide IV over 1 hour on days -5 to -2. Allogeneic
bone marrow is infused on day 0.
Patients who have already had 1 transplant receive high-dose cyclophosphamide IV on days -6
and -5, total body irradiation twice a day on days -4 to -1, and allogeneic bone marrow
infusion on day 0.
All patients receive prophylaxis for graft versus host disease.
Patients are followed every 6 months for at least 2 years.
PROJECTED ACCRUAL: A total of 25-40 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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