NCT07044544 Trial of Novel Anti-leukemia Agents in Flu/Mel RIC Transplant for Myeloid Malignancies
| NCT ID | NCT07044544 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Alabama at Birmingham |
| Condition | Myeloid Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-07-17 |
| Primary Completion | 2026-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
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 willing to donate peripheral blood stem cells and be medically eligible to donate stem cells according to National Marrow Donor Program (NMDP) criteria. 3. A candidate for reduced intensity preparative regimen, based on age≥60, or HCT-CI of ≥4, or considered by the treating physician to have high risk for toxicity with myeloablative preparative regimen. 4. Cardiac function: Ejection fraction \>40% 5. Ca