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

Evaluation of DASATINIB Monotherapy 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Drug: Dasatinib

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Dominique GENRE, Dr; Phone Number: +33491223778; Email: drci.up@ipc.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tumor response	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.	2 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes

Study record dates

Study Major Dates

• Study Start (Estimated): December 31, 2023
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Dasatinib
• Other Study ID Numbers: VEN-R DASA-IPC 2022-067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No