Acute Myeloid Leukemia
Conditions
Brief summary
Stage 1 of the study: assessment of safety of the addition of gilteritinib to the AGORA treatment platform Safety of combining gilteritinib with the GO-cytarabine AGORA platform in patients with FLT3-ITD and/or FLT3-TKD mutated R/R AML will be assessed through the identification of dose-limiting toxicities (DLTs) if any., Stage 2 of the study: assessment of efficacy of gilteritinib-combined to GO/cytarabine AGORA platform through EFS. The definition of EFS will be adapted to the current real-life setting, including the increasing number of experimental options. Actually, the decision to switch toward another therapy may be influenced by other events than hematologic relapse, like suboptimal tolerance or MRD monitoring or simply availability of new promising options.
Detailed description
Response rate, including CR, CRi and CRh*; the overall response rate (ORR) being defined as CR/CRi/CRh rates *: CRi, CR with incomplete hematologic recovery, meaning CR with platelet count <100,000/µL or absolute neutrophil count <1000/µL; CRh, CR with partial hematologic recovery, meaning CR not fulfilling CR or CRi criteria but with platelet count >50,000/µL AND absolute neutrophil count >500/µL., Early mortality rates, at day-30, Incidence of subsequent allogeneic HSCT, overall and in responding patients specifically, Duration of response (DOR), relapse-free survival (RFS) and overall survival (OS), Subgroup analyses: Subgroups defined by a patient related factor: age (<65 vs ≥65y), Subgroups defined by disease related factors: cytogenetics, mutation profiles (including NPM1 and FLT3-ITD), ELN-risk classification 2022 Subgroups defined by treatment related factor by the performance of a subsequent allogeneic HSCT, Safety through the occurrence of (AEs), serious adverse events (SAEs), and treatment emergent adverse events (TEAEs), Patient reported outcome
Interventions
Sponsors
Centre Antoine Lacassagne
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage 1 of the study: assessment of safety of the addition of gilteritinib to the AGORA treatment platform Safety of combining gilteritinib with the GO-cytarabine AGORA platform in patients with FLT3-ITD and/or FLT3-TKD mutated R/R AML will be assessed through the identification of dose-limiting toxicities (DLTs) if any., Stage 2 of the study: assessment of efficacy of gilteritinib-combined to GO/cytarabine AGORA platform through EFS. The definition of EFS will be adapted to the current real-life setting, including the increasing number of experimental options. Actually, the decision to switch toward another therapy may be influenced by other events than hematologic relapse, like suboptimal tolerance or MRD monitoring or simply availability of new promising options. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, including CR, CRi and CRh*; the overall response rate (ORR) being defined as CR/CRi/CRh rates *: CRi, CR with incomplete hematologic recovery, meaning CR with platelet count <100,000/µL or absolute neutrophil count <1000/µL; CRh, CR with partial hematologic recovery, meaning CR not fulfilling CR or CRi criteria but with platelet count >50,000/µL AND absolute neutrophil count >500/µL., Early mortality rates, at day-30, Incidence of subsequent allogeneic HSCT, overall and in responding patients specifically, Duration of response (DOR), relapse-free survival (RFS) and overall survival (OS), Subgroup analyses: Subgroups defined by a patient related factor: age (<65 vs ≥65y), Subgroups defined by disease related factors: cytogenetics, mutation profiles (including NPM1 and FLT3-ITD), ELN-risk classification 2022 Subgroups defined by treatment related factor by the performance of a subsequent allogeneic HSCT, Safety through the occurrence of (AEs), serious adverse even | — |
Countries
France
Outcome results
None listed