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

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.

Eligibility

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

Conditions2

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