About this trial
The goal of this clinical trial is to learn about the efficacy of DASATINIB monotherapy in acute myeloid leukemia patients refractory to VENETOCLAX-AZACITIDINE. The main question it aims to answer is to assess the tumor response after 2 cycles of DASATINIB monotherapy treatment for patients with chemotherapy-ineligible acute myeloid leukemia refractory to VENETOCLAX-AZACITIDINE therapy.
Participants will be given DASATINIB treatment up to 3 months. Response will be assessed by a myelogram and a complete blood count at the end of every cycle. Follow up will last 6 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed diagnosis of AML except Philadelphia chromosome-positive AML (Ph+) and acute promyelocytic leukemia (AML M3)
Age ≥ 18 years
ECOG ≤3
VEN-AZA refractory defined as no response after two cycles of VEN-AZA whatever the dose and the treatment duration
Disqualifiers
Patient eligible to a targeted therapy having a market authorization
Central nervous system involvement
Heart failure
Liver failure
Trial design
Single group
Treatments tested in this trial
Dasatinib
DrugDaily orally administration of DASATINIB
Treatment groups
Trial outcomes
Primary outcomes
tumor response
Objective response rate after 2 cycles of 28 days DASATINIB defined as the rate of complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) according to ELN 2022 criteria.
Secondary outcomes
response rates
Different response rates (RC, CRi, or partial remission (PR)) according to ELN 2022 criteria.
Time to response
Time to response (time between the start of the treatment until achievement of the CR, CRi or PR)
Duration of relapse-free period
Duration of relapse-free period (time between the response time and the relapse)
Event-free survival
Event-free survival (EFS, time between start of treatment and relapse, no response or death)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.