Phase III Trial of T Lymphocyte Depletion by Elutriation and CD34 Add-Back for Allogeneic Bone Marrow Transplantation
- 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
- 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.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Incidence of graft-vs-host disease or graft failure
Richard J. Jones, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|