NCT06055621 Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE
| NCT ID | NCT06055621 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institut Paoli-Calmettes |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2024-05-22 |
| Primary Completion | 2026-07-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 35 participants in total. It began in 2024-05-22 with a primary completion date of 2026-07-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06055621 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06055621 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06055621 currently recruiting?
Yes, NCT06055621 is actively recruiting participants. Contact the research team at drci.up@ipc.unicancer.fr for enrollment information.
Where is the NCT06055621 trial being conducted?
This trial is being conducted at Marseille, France.
Who is sponsoring the NCT06055621 clinical trial?
NCT06055621 is sponsored by Institut Paoli-Calmettes. The trial plans to enroll 35 participants.
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