Combination Salvage Therapy With Venetoclax and Decitabine in Relapsed/Refractory AML

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.

NCT Number	NCT06156579
Lead Sponsor	University Hospital Tuebingen
Conditions	AML, MDS
Enrollment	27 participants
Start Date	2023-11-04
Primary Completion	2026-09-01 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2025-04-08