Leukemia Clinical Trial
Official title:
Randomized Trial of Busulfan or Total Body Irradiation Conditioning Regimens for Children With Acute Lymphoblastic Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining chemotherapy with bone marrow transplantation may
allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy,
radiation therapy, and bone marrow transplantation may kill more cancer cells.
PURPOSE: Randomized phase III trial to compare high-dose chemotherapy with or without
total-body irradiation before bone marrow transplantation in treating children with acute
lymphoblastic leukemia.
OBJECTIVES: I. Compare the efficacy of a busulfan containing conditioning regimen versus a
total body irradiation (TBI) containing regimen for children with acute lymphoblastic
leukemia (ALL) undergoing allogeneic bone marrow transplantation. II. Compare relapse rate
between a chemotherapy only regimen versus a total body irradiation containing regimen for
children with ALL. III. Assess and compare the acute and chronic neuropsychological effects
of bone marrow transplantation (BMT) in children undergoing BMT with busulfan or TBI
conditioning regimens. IV. Assess and compare the cardiac, pulmonary and growth effects of
BMT in children undergoing this conditioning regimen. V. Assess the relationship between
plasma busulfan levels and relapse and toxicity. VI. Assess and compare minimal residual
disease patterns by quantitative polymerase chain reaction (PCR) in patients receiving
busulfan or TBI conditioning regimens.
OUTLINE: This is a multicenter, randomized study comparing a chemotherapy only arm,
including busulfan, with a TBI containing arm. Arm I patients receive TBI on days -7, -6,
and -5 given in 2 fractions daily. Arm II patients receive busulfan every 6 hours on days
-8, -7, -6, and -5. Both regimens are followed by etoposide over 4 hours on day -4 and
cyclophosphamide intravenously (IV) on days -3 and -2. Marrow infusion begins following a
day of rest. Starting on day -1, cyclosporine IV is administered every 12 hours or by
continuous infusion and continues until day 50. Methotrexate IV is administered on days 1,
3, and 6
PROJECTED ACCRUAL: A total of 230 patients will be entered into this study.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
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