A RANDOMIZED TRIAL OF UNMODIFIED VERSUS T-CELL DEPLETED ALLOGENEIC HLA-IDENTICAL BONE MARROW TRANSPLANTATION FOR THE TREATMENT OF ACUTE LEUKEMIAS
OBJECTIVES: I. Compare the efficacy of T-cell-depleted vs unmodified allogeneic marrow
rescue with regard to disease-free survival, post-transplantation leukemic relapse rate,
incidence and severity of graft-versus-host disease, quality of engraftment and
hematopoietic reconstitution, and immunoreconstitution following transplantation in patients
with acute leukemia in first or second remission.
OUTLINE: This is a randomized study. Patients are stratified according to disease (acute
lymphocytic leukemia (ALL) vs acute myeloid leukemia (AML), and age (20 and under vs over
20). Patients are randomized to one of two treatment arms. Patients under age 5 are
nonrandomly assigned to Arm I and those over age 55 are nonrandomly assigned to Arm II. Arm
I: Patients receive total body radiotherapy on days -7 through -4 followed by
cyclophosphamide IV on days -3 and -2. Patients undergo allogeneic bone marrow
transplantation (ABMT) IV over 2-4 hours on day 0. Patients also receive standard graft vs
host disease prophylaxis with cyclosporine and methotrexate. Arm II: Patients receive total
body radiotherapy on days -9 through -6, thiotepa IV on days -5 and -4, and cyclophosphamide
as in Arm I. Patients undergo T-cell depleted ABMT IV over 15 minutes on day 0. Patients
over age 15 receiving bone marrow from female donors over age 30 or from male donors of any
age also receive graft rejection prophylaxis consisting of antithymocyte globulin IV over
6-8 hours on days -5 and -4 and oral methylprednisolone twice daily on days -5 and -4.
Beginning 2 months following transplantation, adult patients with AML and a prior history of
CNS disease, all adult patients with ALL, and all pediatric patients (ALL and ANLL) receive
CNS leukemia prophylaxis with cytarabine intrathecally with the diagnostic lumbar puncture
and then monthly for 5 months (1 year in patients with a prior history of CNS leukemia).
PROJECTED ACCRUAL: A total of 128 patients will be randomized. At an anticipated accrual
rate of 35 patients/year, accrual is expected to be completed in 4 years.
Primary Purpose: Treatment
Farid Boulad, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|