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NCT Number: NCT06055621

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dasatinib

Drug

Daily orally administration of DASATINIB

Primary outcomes

  1. tumor response

    Time frame: 2 months

    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

  1. response rates

    Time frame: 3 months

    Different response rates (RC, CRi, or partial remission (PR)) according to ELN 2022 criteria.

  2. Time to response

    Time frame: 3 months

    Time to response (time between the start of the treatment until achievement of the CR, CRi or PR)

  3. Duration of relapse-free period

    Time frame: 3 months

    Duration of relapse-free period (time between the response time and the relapse)

  4. Event-free survival

    Time frame: 3 months

    Event-free survival (EFS, time between start of treatment and relapse, no response or death)

  5. Overall survival

    Time frame: 3 months

    Overall survival (duration of survival from the start of the treatment)

  6. Occurrence of Adverse Events

    Time frame: 3 months

    Occurrence of Adverse Events according to CTCAE v5.0 and Serious Adverse Reaction

Study contacts

Contact information is provided by the study sponsor or research team.

Jihane PAKARANOUNI, PharmD,PhD

CONTACT

[email protected]

+33491223778

Laurie-Anne GOUTY, PhD

CONTACT

[email protected]

33491223778

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

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

Acronym: VEN-R DASA

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 28, 2023
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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