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

NCT ID: NCT06055621

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-22

Study Completion Date

2027-10-31

Brief Summary

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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

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Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DASATINIB

Group Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

Daily orally administration of DASATINIB

Interventions

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Dasatinib

Daily orally administration of DASATINIB

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Paoli-Calmettes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Paoli Calmettes

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jihane PAKARANOUNI, PharmD,PhD

Role: CONTACT

+33491223778

Laurie-Anne GOUTY, PhD

Role: CONTACT

33491223778

Facility Contacts

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Jihane PAKRADOUNI, Dr

Role: primary

0033491223778

Laurie-Anne GOUTY, PhD

Role: backup

33491223778

Other Identifiers

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VEN-R DASA-IPC 2022-067

Identifier Type: -

Identifier Source: org_study_id

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