VEN-R DASA: Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE

Institut Paoli-Calmettes (Other)
Overall Status
Not yet recruiting ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Anticipated Enrollment :
35 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Evaluation of DASATINIB Monotherapy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE
Anticipated Study Start Date :
Oct 31, 2023
Anticipated Primary Completion Date :
Oct 31, 2025
Anticipated Study Completion Date :
Oct 31, 2025

Outcome Measures

Primary Outcome Measures

  1. tumor response [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 Outcome Measures

  1. response rates [3 months]

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

  2. Time to response [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 [3 months]

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

  4. Event-free survival [3 months]

    Event-free survival (EFS, time between start of treatment and relapse, progression or death)

  5. Overall survival [3 months]

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

  6. Occurrence of Adverse Events [3 months]

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

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Confirmed diagnosis of AML except acute promyelocytic leukemia (AML M3)

  • Age ≥ 18 years

  • ECOG ≤3

  • VEN-AZA refractory defined as no response or as a progression after one or 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:
  • Central nervous system involvement

  • Heart failure

  • Liver failure

  • Kidney failure

  • Contraindication to DASATINIB

  • Positive for HIV, 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

Contacts and Locations


No locations specified.

Sponsors and Collaborators

  • Institut Paoli-Calmettes


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Institut Paoli-Calmettes Identifier:
Other Study ID Numbers:
  • VEN-R DASA-IPC 2022-067
First Posted:
Sep 28, 2023
Last Update Posted:
Sep 28, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2023