Hypomethylating Agent and Venetoclax After Allo-HSCT in Patients With High-risk Myeloid Malignancies.

PHASE2RecruitingINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

January 1, 2023

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2025

Conditions
Hypomethylating AgentVenetoclaxMyeloid Malignancy
Interventions
DRUG

Venetoclax

"Participants will receive maintenance therapy with venetoclax and azacitidine or decitabine after allogeneic stem cell transplantation.~Azacitidine will be administered once daily subcutaneously (32mg/m2/d) on days 1-5, and venetoclax will be administered once daily orally (400mg/day) on days 1-7. If the patient is refractory or allergic to azacitidine, they will receive decitabine. Decitabine will be administered intravenously (5mg/m2/d) on days 1-5. If the patient is treated with CYP450 inhibitors(such as posaconazole or voriconazole), the dose of venetoclax will reduce to 100 mg once daily on days 1-7. Maintenance therapy will start from the 60th to 120th days after allogeneic hematopoietic stem cell transplantation and repeat every 28 days for up to 10 cycles within the first year after transplantation."

DRUG

Azacitidine or decitabine

azacytidine 32mg/m2 or decitabine 5mg/m2

Trial Locations (1)

200080

RECRUITING

Shanghai Jiao Tong University School of Medicine Affilated Shanghai General Hospital, Shanghai

All Listed Sponsors
lead

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER