Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE
Recruiting now · Phase 2
Conditions studied: Acute Myeloid Leukemia
In brief
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.
Key facts
- Study ID
- NCT06055621
- Run by
- Institut Paoli-Calmettes
- People needed
- 35
- Starts
- 2024-05-22
- Expected to finish
- 2027-10-31
- Last updated by the study team
- 2026-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Institut Paoli Calmettes — Marseille, France (enrolling)
Full record on ClinicalTrials.gov
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