Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE

Acute Myeloid Leukemia Clinical Trial

— VEN-R DASA  

Official title:

Evaluation of DASATINIB Monotherapy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06055621
• Other study ID #: VEN-R DASA-IPC 2022-067
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 31, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: September 2023
• Source: Institut Paoli-Calmettes
• Contact: Dominique GENRE, Dr
• Phone: +33491223778
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Dasatinib
Daily orally administration of DASATINIB

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor response	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.	2 months
Secondary	response rates	Different response rates (RC, CRi, or partial remission (PR)) according to ELN 2022 criteria.	3 months
Secondary	Time to response	Time to response (time between the start of the treatment until achievement of the CR, CRi or PR)	3 months
Secondary	Duration of relapse-free period	Duration of relapse-free period (time between the response time and the relapse)	3 months
Secondary	Event-free survival	Event-free survival (EFS, time between start of treatment and relapse, no response or death)	3 months
Secondary	Overall survival	Overall survival (duration of survival from the start of the treatment)	3 months
Secondary	Occurrence of Adverse Events	Occurrence of Adverse Events according to CTCAE v5.0 and Serious Adverse Reaction	3 months