VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS

PHASE2RecruitingINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

July 18, 2024

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2027

Conditions
Relapsed Acute Myeloid LeukemiaRefractory Acute Myeloid LeukemiaMyelodysplastic SyndromesMinimal Residual Disease
Interventions
DRUG

PD-1 inhibitor, Venetoclax, Decitabine, Azacytidine

"For AML patients: PD-1 inhibitor was given at a dose of 200mg on day 21 of the treatment. Venetoclax was given at a dose of 400 mg/day for 28 days per cycle. Decitabine was given at a dose of 20 mg/m2/day for 5 days or azacytidine was given at a dose of 75 mg/m2/day for 7 days at the discretion of the treating physician.~For MDS patients: PD-1 inhibitor was given at a dose of 200mg on day 21 of the treatment. Venetoclax was given at a dose of 400 mg/day for 14 days per cycle. Decitabine was given at a dose of 20 mg/m2/day for 5 days or azacytidine was given at a dose of 75 mg/m2/day for 7 days at the discretion of the treating physician.~The venetoclax starting dose is 100 mg on the first day, ramping up to 200 mg on the second day and finally 400 mg once daily. The steady daily dose (after ramp-up phase) should be reduced to 100 mg (coadministered with moderate CYP3A inhibitors or P-gp inhibitors) and 70 mg (coadministered with strong CYP3A4 inhibitors)."

Trial Locations (1)

100071

RECRUITING

Xiao-ning Gao, Beijing

All Listed Sponsors
lead

Beijing 302 Hospital

OTHER