University of Alabama at Birmingham
The purpose of this study is to determine the safety of adding Decitabine and Venetoclax to patients undergoing reduced intensity allogenic transplantation for treatment of hematologic malignances with Fludarabine and Melphalan.
The purpose of this study is to evaluate the safety, tolerability and preliminary activity of decitabine and venetoclax as part of RIC AHSCT in patients with high-risk AML and MDS. The study will follow a standard 3+3 design commonly used in phase I studies. Dose-adjustments will be made based on the incidence of dose-limiting toxicities (DLTs). The DLT period is from the first dose of decitabine to day 28 post-transplant. Cohort 1 DL1: G-CSF + Decitabine (100mg/m2 bid for 2d) Cohort 1 DL-1: G-CSF + Decitabine (50mg/m2 bid for 2d) Cohort 2 DL1: G-CSF + Decitabine + Ven (200mg/d for 7d) Cohort…
Inclusion Criteria: 1. Adult male or female, age 18-75 years 2. Patients must have a related or unrelated peripheral blood stem cell donor. Sibling donor must be a 6/6 match for HLA-A and -B at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing, and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation. Unrelated donor must the following: have Optimum: HLA-A, -B, -C, -DRB1, -DRB3/4/5, -DQA1, -DQB1, -DPA1 and -DPB1; Minimum: HLA-A, -B, -C, -and DRB1 matching at high resolution using DNA-based typing and be willi…
Granulocyte colony-stimulating factor (G-CSF) is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream.
Decitabine is a hypomethylating agent.
Venetoclax is a selective inhibitor of BCL-2 protein.
Arctuva estimate
Verify or correct the compensation shown for this listing.