VEN-R DASA: Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Outcome Measures
Primary Outcome Measures
- tumor response [2 months]
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 Outcome Measures
- response rates [3 months]
Different response rates (RC, CRi, or partial remission (PR)) according to ELN 2022 criteria.
- Time to response [3 months]
Time to response (time between the start of the treatment until achievement of the CR, CRi or PR)
- Duration of relapse-free period [3 months]
Duration of relapse-free period (time between the response time and the relapse)
- Event-free survival [3 months]
Event-free survival (EFS, time between start of treatment and relapse, progression or death)
- Overall survival [3 months]
Overall survival (duration of survival from the start of the treatment)
- Occurrence of Adverse Events [3 months]
Occurrence of Adverse Events according to CTCAE v5.0 and Serious Adverse Reaction
Eligibility Criteria
Criteria
Inclusion Criteria:
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Confirmed diagnosis of AML except acute promyelocytic leukemia (AML M3)
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Age ≥ 18 years
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ECOG ≤3
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VEN-AZA refractory defined as no response or as a progression after one or two cycles of VEN-AZA whatever the dose and the treatment duration
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Signed informed consent form
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Affiliation to a social security system, or beneficiary of such a system
Exclusion Criteria:
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Central nervous system involvement
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Heart failure
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Liver failure
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Kidney failure
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Contraindication to DASATINIB
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Positive for HIV, Hepatitis B or C
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Pregnant or breastfeeding woman
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No efficient contraception for the women of childbearing age
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Emergency situation person or not able to express his/her informed consent
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Patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice)
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Inability to undergo the clinical trial medical follow-up for geographical, social or psychological reasons
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Institut Paoli-Calmettes
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VEN-R DASA-IPC 2022-067