Combination Salvage Therapy With Venetoclax and Decitabine in Relapsed/Refractory AML
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria 1\. Diagnosis of AML according to WHO criteria regardless of subtype, including de novo and transformed MPN and transformed MDS 2. A. Refractory to induction chemotherapy consisting of Daunorubicin+Cytarabin ("3+7") based chemotherapy, including CPX351, including combinations with GemtuzumabOzogamicin or with the FLT3-inhibitors Midostaurin or Quizartinib. This trial defines refractory disease as one of the following: i. ≥20% bone marrow blasts\*\* at day 15\*\*\* first cycle of intensive induction chemotherapy ii. ≥5-20% bone marrow blasts\*\* at day 15\*\*\* of first cycle of intensive induction chemotherapy in patients, in whom relative blast count reduction as compared to initial diagnosis is ≤50% iii. c) ≥5% bone marrow blasts\*\* at day 28\*\*\*\* of first cycle of induction chemotherapy, or at any point during a second cycle of induction chemotherapy OR 2. B. Relapse of AML/MDS IB2 after chemotherapy (≥5% medullary blasts in bone marrow assessment\*\*) 3. Must