Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dasatinib | Drug | Dasatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DASATINIB
- interventionNames
- Drug: Dasatinib
Primary outcomes (1)
- measure
- tumor response
- timeFrame
- 2 months
- description
- 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.
Secondary outcomes (6)
- measure
- response rates
- timeFrame
- 3 months
- description
- Different response rates (RC, CRi, or partial remission (PR)) according to ELN 2022 criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available