Combination Salvage Therapy With Venetoclax and Decitabine in Relapsed/Refractory AML
Status:
Recruiting
Trial end date:
2025-03-04
Target enrollment:
Participant gender:
Summary
The goal of this prospective, phase II single center, one arm, open label clinical trial is
to test the efficacy and feasibility of a combination salvage therapy with Venetoclax and
intensified Decitabine in patients with newly diagnosed AML (acute myeloid leukemia) and
primary induction failure and patients with relapse of AML/MDS IB2 (myelodysplastic neoplasm
with increased blasts 2) after chemotherapy. The primary endpoint is hematologic remission
after treatment with Decitabine and Venetoclax. Participants eligible for the trial will
receive a treatment of ten days of Decitabine and twenty-eight days of Venetoclax for one or
two cycles, after which hematological remission will be assessed. Follow up will include the
first one hundred days after end of treatment.