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

Institut Paoli-Calmettes

Status and phase: Enrolling; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Dasatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT06055621

VEN-R DASA-IPC 2022-067

Details and patient eligibility

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

DASATINIB

Experimental group

Treatment:

Drug: Dasatinib