NCT05583175

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Xianmin Song, MD · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia, Myeloid, Acute
• MDS
• Hematopoietic Stem Cell Transplantation
• Myeloid Malignancy

Interventions

Type	Name	Description
DRUG	Venetoclax plus RIC	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), TBI: 3 Gray, - 1d.

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2022-10-17
• Last updated: 2023-11-28

Locations

1 site across 1 country: China