Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Evaluation of DASATINIB Monotherapy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: Dasatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Signed informed consent form Affiliation to a social security system, or beneficiary of such a system Exclusion Criteria: Patient eligible to a targeted therapy having a market authorization Central nervous system involvement Heart failure Liver failure Kidney failure Contraindication to DASATINIB Positive for HIV (detectable viral load), Hepatitis B or C Pregnant or breastfeeding woman No efficient contraception for the women of childbearing age Emergency situation person or not able to express his/her informed consent Patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice) Inability to undergo the clinical trial medical follow-up for geographical, social or psychological reasons

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dasatinib|Daily orally administration of DASATINIB|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rates | Different response rates (RC, CRi, or partial remission (PR)) according to ELN 2022 criteria. | 3 months | 
| Time to response | Time to response (time between the start of the treatment until achievement of the CR, CRi or PR) | 3 months | 
| Duration of relapse-free period | Duration of relapse-free period (time between the response time and the relapse) | 3 months | 
| Event-free survival | Event-free survival (EFS, time between start of treatment and relapse, no response or death) | 3 months | 
| Overall survival | Overall survival (duration of survival from the start of the treatment) | 3 months | 
| Occurrence of Adverse Events | Occurrence of Adverse Events according to CTCAE v5.0 and Serious Adverse Reaction | 3 months |