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

Last updated: June 13, 2025
Sponsor: Institut Paoli-Calmettes
Overall Status: Active - Recruiting

Phase

2

Condition

Acute Myeloid Leukemia

Leukemia

Platelet Disorders

Treatment

Dasatinib

Clinical Study ID

NCT06055621
VEN-R DASA-IPC 2022-067
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Confirmed diagnosis of AML except Philadelphia chromosome-positive AML (Ph+) andacute promyelocytic leukemia (AML M3)

  • Age ≥ 18 years

  • ECOG ≤3

  • VEN-AZA refractory defined as no response after two cycles of VEN-AZA whatever thedose and the treatment duration

  • Signed informed consent form

  • Affiliation to a social security system, or beneficiary of such a system

Exclusion

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 orsafeguard of justice)

  • Inability to undergo the clinical trial medical follow-up for geographical, socialor psychological reasons

Study Design

Total Participants: 35
Treatment Group(s): 1
Primary Treatment: Dasatinib
Phase: 2
Study Start date:
May 22, 2024
Estimated Completion Date:
October 31, 2027

Connect with a study center

  • Institut Paoli Calmettes

    Marseille,
    France

    Active - Recruiting

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