Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE
Evaluation of DASATINIB Monotherapy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE
Institut Paoli-Calmettes
35 participants
May 22, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria12
- 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
Interventions
Daily orally administration of DASATINIB
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06055621