Evaluating Dasatinib for Acute Myeloid Leukemia Patients Not Responding to Other Treatments
Evaluation of DASATINIB Monotherapy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE
PHASE2 · Institut Paoli-Calmettes · NCT06055621
This study is testing if a drug called Dasatinib can help people with acute myeloid leukemia who haven't responded to other treatments feel better.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Paoli-Calmettes (other) |
| Drugs / interventions | DASATINIB, chemotherapy |
| Locations | 1 site (Marseille) |
| Trial ID | NCT06055621 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy of Dasatinib monotherapy in patients with acute myeloid leukemia (AML) who have not responded to previous treatment with Venetoclax and Azacitidine. Participants will receive Dasatinib for up to three months, with their response evaluated through myelograms and complete blood counts after each treatment cycle. The study will follow participants for six months to monitor outcomes and side effects.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed AML who are refractory to Venetoclax and Azacitidine.
Not a fit: Patients with Philadelphia chromosome-positive AML, acute promyelocytic leukemia, or those eligible for other targeted therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for AML patients who have limited treatment choices.
How similar studies have performed: While there have been studies on Dasatinib in other contexts, this specific approach for refractory AML is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Marseille
- Institut Paoli Calmettes — Marseille, France (RECRUITING)
Study contacts
- Study coordinator: Jihane PAKARANOUNI, PharmD,PhD
- Email: drci.up@ipc.unicancer.fr
- Phone: +33491223778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Myeloid Leukemia