Acute Myeloid Leukemia
Conditions
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.
Interventions
DRUGDasatinib
Daily orally administration of DASATINIB
Sponsors
Institut Paoli-Calmettes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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, no response 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 |
Countries
France
Contacts
CONTACTJihane PAKARANOUNI, PharmD,PhD
CONTACTLaurie-Anne GOUTY, PhD
Outcome results
None listed