Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06055621

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

Led by Institut Paoli-Calmettes · Updated on 2026-03-13

35

Participants Needed

1

Research Sites

179 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of AML except Philadelphia chromosome-positive AML and acute promyelocytic leukemia
  • Age 18 years or older
  • ECOG performance status of 3 or less
  • No response after two cycles of VENETOCLAX-AZACITIDINE treatment
  • Signed informed consent form
  • Affiliated with or beneficiary of a social security system
Not Eligible

You will not qualify if you...

  • Eligible for a targeted therapy with market authorization
  • Central nervous system involvement
  • Heart failure
  • Liver failure
  • Kidney failure
  • Contraindication to DASATINIB
  • Positive for HIV, Hepatitis B, or Hepatitis C
  • Pregnant or breastfeeding
  • No effective contraception for women of childbearing age
  • Emergency situation or unable to give informed consent
  • Under legal protection measures
  • Unable to follow trial medical requirements due to geographic, social, or psychological reasons

AI-Screening

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Trial Site Locations

Total: 1 location

1

Institut Paoli Calmettes

Marseille, France

Actively Recruiting

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Research Team

J

Jihane PAKARANOUNI, PharmD,PhD

CONTACT

L

Laurie-Anne GOUTY, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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