FDA Approves CliniMACS CD34 Reagent System for the Prevention of Graft-vs-Host Disease in AML

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The U.S. Food and Drug Administration (FDA) has approved the Miltenyi Biotec’s CliniMACS CD34 Reagent System as a Humanitarian Use Device for the prevention of graft-vs-host disease in patients with acute myeloid leukemia (AML) in first complete remission undergoing allogeneic stem cell transplantation from a matched related donor.

The CliniMACS CD34 Reagent System decreases the risk of developing graft-vs-host disease, a life-threatening complication that can occur following an allogeneic transplant, in which T cells from the donor attack various tissues of the recipient. The FDA-approved device removes donor T cells from the graft prior to transplantation by enriching CD34+ blood stem cells, which go on to repopulate the patient’s immune and blood building systems.

Phase II Trial

The FDA approval was based on data from a phase II, single-arm, multicenter study (BMT CTN 0303) conducted by the Blood and Marrow Transplant Clinical Trials Network, which showed that following intensive myeloablative conditioning, stem cell transplantation from an identical sibling donor processed using the CliniMACS CD34 Reagent System as the sole means of graft-host-disease prophylaxis leads to a low incidence of chronic graft-vs-host disease (19% at 2 years after transplantation) without negatively affecting relapse, engraftment, overall survival or disease-free survival.

“The low incidence of acute and chronic graft-vs-host disease, in the absence of additional immunosuppression are distinct advantages in using the CliniMACS CD34 Reagent System,” said Robert J. Soiffer, MD, of Dana-Farber Cancer Institute and investigator in the Blood and Marrow Transplant Clinical Trials Network. ■




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