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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Paoli-Calmettes

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient eligible to a targeted therapy having a market authorization

Central nervous system involvement

Heart failure

Liver failure

Trial design

Design model

Single group

Treatments tested in this trial

  • Dasatinib

    Drug

    Daily orally administration of DASATINIB

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: DASATINIBExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
2 months

Secondary outcomes

1

response rates

Different response rates (RC, CRi, or partial remission (PR)) according to ELN 2022 criteria.

Time frame
3 months
2

Time to response

Time to response (time between the start of the treatment until achievement of the CR, CRi or PR)

Time frame
3 months
3

Duration of relapse-free period

Duration of relapse-free period (time between the response time and the relapse)

Time frame
3 months
4

Event-free survival

Event-free survival (EFS, time between start of treatment and relapse, no response or death)

Time frame
3 months

Other outcomes

Sponsors and contacts

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