Spots Global Cancer Trial Database for Venetoclax Plus RIC Regimen Allo-HSCT for Elderly Patients With High-risk Myeloid Malignancies

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Trial Identification

Brief Title: Venetoclax Plus RIC Regimen Allo-HSCT for Elderly Patients With High-risk Myeloid Malignancies

Official Title: Study of Venetoclax and Reduced-intensity Conditioning Regimen(RIC) for Allogeneic Stem Cell Transplantation(Allo-HSCT) in Elderly Patients With High-risk Myeloid Malignancies

Study ID: NCT05583175

Conditions

Leukemia, Myeloid, Acute

MDS

Hematopoietic Stem Cell Transplantation

Myeloid Malignancy

Interventions

Venetoclax plus RIC

Study Description

Brief Summary: 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.

Detailed Description: Eligible patients will receive Venetoclax plus RIC regimen allogeneic transplantation. The treatment regimen is: Venetoclax 100mg/d - 10d, 200mg/d - 9d (first use and NR or untreated MDS), 400mg/d, - 8d\~ - 2d (7d); Fludarabine: 30mg/m2/d, - 6d\~-2d (5d), Cytarabine: 1g/m2/d, - 6d\~-2d (5d) Busulfan: 3.2mg/m2/d, - 6d\~-5d (2d), total body irradiation(TBI): 3 Gray, - 1d. Primary end point: 1 year and 2 year progression free survival (PFS) after transplantation. Secondary end point: incidence of acute GVHD within 180 days after transplantation; cumulative rate of relapse, overall survival(OS), graft-versus-host disease (GVHD)-free relapse-free survival(GRFS), non-relapse mortality(NRM), and incidence of chronic GVHD at 1 and 2 years after transplantation; The reactivation rate of cytomegalovirus(CMV) and Epstein-Barr virus (EBV) within 1 year after transplantation.