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

NCT06055621 | Recruiting Phase 2 DMC

• 1 other identifier: VEN-R DASA-IPC 2022-067
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• response rates

  3 months

• Time to response

  3 months

• Duration of relapse-free period

  3 months

• Event-free survival

  3 months

• Overall survival

  3 months

Study Arms (1)

DASATINIB

EXPERIMENTAL

Drug: Dasatinib

Interventions

Dasatinib DRUG

Daily orally administration of DASATINIB

DASATINIB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli Calmettes

Marseille, France

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Central Study Contacts

Jihane PAKARANOUNI, PharmD,PhD

CONTACT

+33491223778; drci.up@ipc.unicancer.fr

Laurie-Anne GOUTY, PhD

CONTACT

33491223778; drci.up@ipc.unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 28, 2023
• Study Start: May 22, 2024
• Primary Completion (Estimated): July 8, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 13, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)