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

• Status: Not yet recruiting
• Trial end date: 2025-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Paoli-Calmettes
• Treatments: Dasatinib

Criteria

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