Acute Myeloid Leukemia Clinical Trial
Official title:
Phase 1-2 Trial for Patients With Advanced Hematologic Malignancies Undergoing Myeloablative Allogeneic HCT With a T-cell Depleted Graft With Infusion of Conventional T-cells and Regulatory T-cells
For patients with hematologic malignancies undergoing allogeneic myeloablative (MA) HCT with a T cell depleted graft, the infusion of naturally occurring regulatory T cells with conventional T cells (T cell add back) in pre-defined doses and ratios will reduce the incidence of acute graft vs host disease while augmenting the graft vs leukemia effect and improving immune reconstitution.
Primary Objectives: - To determine the efficacy, safety and feasibility of administration of several dose combinations of conventional T cells (Tcon) and regulatory T cells (Treg) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) with HLA matched donors (related or unrelated) using a T cell depleted graft [CD34+ hematopoietic progenitor cells ("CD34+ HSPC")], without immune suppression. - To determine the maximum tolerated dose of infused regulatory and conventional T cells in the matched donor setting - To determine 1 year event free survival (EFS) post HCT Secondary Objectives: - To determine the 1 year OS in patients undergoing allogeneic HCT with matched donors. - To measure the incidence and severity of acute and chronic graft vs host disease (GvHD) - To measure incidence of serious infections ;
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