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

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

Study summary

The efficiency and safety of PD-1 inhibitor in combination with venetoclax and hypomethylation agent in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndrome remain uncertain. In this study, the investigators aimed to assess safety and response to a new PD-1 inhibitor-based triple-drug combination regimen (venetoclax + hypomethylation agent + PD-1 inhibitor) in relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome patients, or who had positive minimal residual disease.

Eligibility

Primary outcome measure(s)

• Complete remission rate — At the end of Cycle 2 (each cycle is 28 days)
  percentage of subjects with complete remission (CR) and incomplete hematologic recovery (CRi)
• Complete minimal residual disease (MRD) Response Rate — At the end of Cycle 2 (each cycle is 28 days)
  Percentage of subjects with MRD negative or MRD \< 0.01%
• MRD Response Rate — At the end of Cycle 2 (each cycle is 28 days)
  Percentage of subjects with MRD \< 0.1% detectable by multicolor flow cytometry

Trial sites (1)

More Beijing 302 Hospital trials in China

Other trials for the same condition