Study of Venetoclax and Reduced-intensity Conditioning Regimen(RIC) for Allogeneic Stem Cell Transplantation(Allo-HSCT) in Elderly Patients With High-risk Myeloid Malignancies
This study is a single center, single arm, prospective, phase II clinical study to evaluate the efficacy and safety of Venatoclax combined with reduced intensity conditioning regimen allo-HSCT in the treatment of high-risk myeloid malignancies in the elderly patients.
• ≥ 55 years old;
• High risk myeloid malignancies: 1)No hematological remission(NR) after induction/re-induction treatment for AML; 2)Morphological remission but with persistent positive minimal resident disease(MRD) (Flow cytometry\>0.01% and/or fusion gene positive and/or digital polymerase chain reaction(PCR) positive); 3)High risk acute myeloid leukemia(AML) according to 2022 European Leukemia Net(ELN) risk stratification; 4)High risk myelodysplastic syndrome(MDS): IPSS-R score ≥ middle risk-2; therapy-related MDS; MDS with mutation of ASXL1, EZH2, RUNX1, SRSF2, U2AF1, STAG2, NRAS, ZRSR2, or TP53; 5)High risk chronic myelomonocytic leukemia(CMML), MDS/MPN.
• Patients must have appropriate donor:
⁃ 1)Related donor must be HLA-A, - B, - C, - DQB1 and - DRB1 matched at least 5/10; 2)Unrelated donor must be HLA-A, - B, - C, - DQB1 and - DRB1 matched at least 8/10; 4. Hematopoietic cell transplantation-comorbidity Index(HCT-CI) score ≤ 4。 5. Eastern Cooperative Oncology Group(ECOG) score 0-2。 6. Liver, kidney and cardiopulmonary functions meet the following requirements:
• Creatinine≤1.5×ULN;
• Left ventricular ejection fraction \>50%;
• Baseline oxygen saturation\>92%;
• Total bilirubin≤1.5×ULN;ALT and AST≤2.0×ULN;
• DLCO≥ 40% and FEV1 ≥ 50%。 7. Able to understand and sign the Informed Consent Document.