Finding studies
Finding studies
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Lead
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
With
OBJECTIVES: * Compare the effectiveness, in terms of incidence of graft failure and incidence of greater than grade 1 acute graft-vs-host disease, of ex vivo manipulation of bone marrow cells comprising counterflow centrifugal elutriation for T-lymphocyte depletion followed by CD34-positive stem cell selection using CliniMACS vs Isolex 300i in patients with a hematologic malignancy undergoing allogeneic bone marrow transplantation from an HLA-identical sibling donor. OUTLINE: This is a randomized study. Patients are stratified by age (\< 40 vs 40-65) and disease status (low-risk \[i.e., chronic phase chronic myelogenous leukemia, acute myeloid leukemia in first complete remission (CR), acute lymphocytic leukemia in first CR, Hodgkin's or non-Hodgkin's lymphoma in sensitive relapse, or multiple myeloma in CR or partial remission) vs high-risk \[i.e., all others\]). Patients are randomized to 1 of 2 treatment arms. * Arm I: Allogeneic bone marrow cells are subjected to counterflow centrifugal elutriation (CCE) for T-lymphocyte depletion. The elutriation fractions are then processed over 2-2.5 hours using CliniMACS to select for CD34-positive stem cells. * Arm II: Allogeneic bone marrow cells are subjected to CCE for T-lymphocyte depletion. The elutriation fractions are then processed over 4-4.5 hours using Isolex 300i to select for CD34-positive stem cells. Patients in both arms then undergo ex vivo manipulated, T-lymphocyte-depleted, CD34-positive stem cell-selected, allogeneic bone marrow transplantation on day 0. After the transplantation, patients are followed periodically for 1 year. PROJECTED ACCRUAL: A total of 206 patients will be accrued for this study.
Age
0–65
Sex
ALL
Healthy volunteers
Not accepted
