Status:
RECRUITING
Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE
Lead Sponsor:
Institut Paoli-Calmettes
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06055621
Start Date
May 22 2024
End Date
October 31 2027
Last Update
June 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institut Paoli Calmettes
Marseille, France