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

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

Recruiting
18 years and older
All
Phase 2

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Overview

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

Study details
    Acute Myeloid Leukemia

NCT06055621

Institut Paoli-Calmettes

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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