VEN-R DASA-IPC 2022-067 Evaluation of DASATINIB monotherapy in acute myeloid leukemia patients refractory to VENETOCLAX-AZACITIDINE

Conditions

acute myeloid leukemia

Brief summary

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.

Detailed description

Different response rates (RC, CRi, or partial remission (PR)) according to ELN 2022 criteria., Blast clearance rate (morphologic leukemia free state, MLFS) according to ELN 2022 criteria, Time to response (time between the start of the treatment until achievement of the CR, CRi or PR), Duration of relapse-free period (time between the response time and the relapse), Event-free survival (EFS, time between start of treatment and relapse, no reponse or death), Overall survival (duration of survival from the start of the treatment), Occurrence of Adverse Events according to CTCAE v5.0 and Serious Adverse Reaction

Sylvain Garciaz, Camille Montersino, Maxence Bourgoin, Arnaud Jacquel, Rémy Castellano et al. (12 authors)

British Journal of Haematology2025-06-06

10.1111/bjh.20195

Dasatinib Overcomes AML Resistance to BCL2 Inhibition By Indirectly Inhibiting MCL1: From <i>Ex Vivo</i> drug Sensitivity/Resistance Profiling to a Phase II Clinical Trial: A Hemato-BIO Study

Sylvain Garciaz, Rémy Castellano, Arnaud Jacquel, Arnaud Guillé, Maxence Bourgoin et al. (11 authors)

Blood2024-11-05

10.1182/blood-2024-207352

Interventions

DRUGDASATINIB VIATRIS 50 mg

DRUGcomprimé pelliculé

DRUGDASATINIB VIATRIS 70 mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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
Different response rates (RC, CRi, or partial remission (PR)) according to ELN 2022 criteria., Blast clearance rate (morphologic leukemia free state, MLFS) according to ELN 2022 criteria, Time to response (time between the start of the treatment until achievement of the CR, CRi or PR), Duration of relapse-free period (time between the response time and the relapse), Event-free survival (EFS, time between start of treatment and relapse, no reponse or death), Overall survival (duration of survival from the start of the treatment), Occurrence of Adverse Events according to CTCAE v5.0 and Serious Adverse Reaction	—

Measure

Time frame

Different response rates (RC, CRi, or partial remission (PR)) according to ELN 2022 criteria., Blast clearance rate (morphologic leukemia free state, MLFS) according to ELN 2022 criteria, Time to response (time between the start of the treatment until achievement of the CR, CRi or PR), Duration of relapse-free period (time between the response time and the relapse), Event-free survival (EFS, time between start of treatment and relapse, no reponse or death), Overall survival (duration of survival from the start of the treatment), Occurrence of Adverse Events according to CTCAE v5.0 and Serious Adverse Reaction

—

Countries

France

Outcome results

None listed