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

Phase 2

Recruiting

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Dasatinib

• Registration Number: NCT06055621
• Lead Sponsor: Institut Paoli-Calmettes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-28
• Study Start: 2024-05-22
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-07
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DASATINIB	Dasatinib	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
response rates	3 months	Different response rates (RC, CRi, or partial remission (PR)) according to ELN 2022 criteria.
Time to response	3 months	Time to response (time between the start of the treatment until achievement of the CR, CRi or PR)
Duration of relapse-free period	3 months	Duration of relapse-free period (time between the response time and the relapse)
Event-free survival	3 months	Event-free survival (EFS, time between start of treatment and relapse, no response or death)
Overall survival	3 months	Overall survival (duration of survival from the start of the treatment)
Occurrence of Adverse Events	3 months	Occurrence of Adverse Events according to CTCAE v5.0 and Serious Adverse Reaction

Trial Locations

Locations (1)

Institut Paoli Calmettes; 🇫🇷 Marseille, France