Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission
|ClinicalTrials.gov Identifier: NCT00002534|
Recruitment Status : Completed
First Posted : April 22, 2004
Last Update Posted : June 26, 2013
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.
PURPOSE: Randomized phase III trial to compare the effectiveness of bone marrow transplantation using untreated or treated bone marrow in treating patients with acute leukemia in first or second remission.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Biological: anti-thymocyte globulin Drug: cyclophosphamide Drug: cytarabine Drug: methylprednisolone Drug: thiotepa Procedure: allogeneic bone marrow transplantation Procedure: in vitro-treated bone marrow transplantation Radiation: low-LET electron therapy Radiation: low-LET photon therapy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A RANDOMIZED TRIAL OF UNMODIFIED VERSUS T-CELL DEPLETED ALLOGENEIC HLA-IDENTICAL BONE MARROW TRANSPLANTATION FOR THE TREATMENT OF ACUTE LEUKEMIAS|
|Study Start Date :||May 1993|
|Primary Completion Date :||April 2003|
|Study Completion Date :||April 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002534
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Farid Boulad, MD||Memorial Sloan Kettering Cancer Center|