Acute lymphocytic leukaemia- Acute myeloid leukaemia refractory - Myelodysplastic syndrome - Blastic plasmacytoid dendritic cell neoplasia
Conditions
Brief summary
Escalation Part: Incidence of dose-limiting toxicity (DLT), Japan Cohort C: Incidence of DLT in Japanese participant, Expansion/Optimization part (Cohorts A1, A2 & D), AML: Proportion of participants who have a CR + CRh + CRi according to the modified AML IWG 2003 criteri, Expansion/Optimization part (Cohort B), MDS: Overall response rate (CR + CR equivalent + PR + CRL + CRh + HI) according to the IWG 2023 MDS response criteria
Detailed description
Expansion/Optimization part – Cohorts A, B and D: Recommended dose for expansion (RDE), Escalation and Expansion/Optimization parts – Cohorts A, B, C and D: Number of participants with TEAEs, Escalation and Expansion/Optimization parts – Cohorts A, B, C and D: Ctrough, Escalation and Expansion/Optimization parts – Cohorts A, B, C and D: Incidence of ADA, Escalation and Expansion/Optimization parts – Japan Cohort C, AML: Rate of CR + CRh + CRi per AML 2003 modified IWG response criteria, Escalation and expansion/Optimization parts – Japan Cohort C, MDS: CR rate and ORR rate per IWG 2023 MDS response criteria for escalation part and ORR rate per IWG 2023, Escalation and Expansion/Optimization parts – Japan Cohort C, B-ALL: Rate of CR + CRh + CRi as defined by National Comprehensive Cancer Network (NCCN), Expansion/Optimization part – Cohorts A and D: Overall response rate (ORR), Expansion/Optimization part – Cohorts A and D: Duration of CR + CRh + CRi (Duration of CRc), Expansion/Optimization part – Cohorts A and D: Duration of CR + CRi + CRh + PR + MLFS (Duration of overall response rate), Expansion/Optimization part – Cohorts A and D: Alternative CR rate, Expansion/Optimization part – Cohorts A and D: Duration of CR + CRh (Duration of alternative CR), Expansion/Optimization part – Cohorts A and D: Event-free survival (EFS), Expansion/Optimization part – Cohorts A and D: Overall survival (OS), Expansion/Optimization part – Cohorts A and D: Rate of hematopoietic stem cell transplantation (HSCT), Expansion/Optimization part – Cohorts A and D: Time to treatment failure (TTF), Expansion/Optimization part – Cohorts A and D: Rate of conversion from transfusion dependence, Expansion/Optimization part – Cohorts A and D: Rate of participants who are transfusion independent at baseline and remain independent during 56-day postbaseline period, Expansion/Optimization part – Cohort B: Alternative CR rate, Expansion/Optimization part – Cohort B: Duration of ORR, Expansion/Optimization part – Cohort B: Eventfree survival (EFS), Expansion/Optimization part – Cohort B: Overall survival (OS), Expansion/Optimization part – Cohort B: Rate of hematopoietic stem cell transplantation (HSCT), Expansion/Optimization part – Cohort B: Time to treatment failure (TTF), Expansion/Optimization part – Cohort B: Duration of alternative CR (CR + CR equivalent + CRL + CRh), Expansion/Optimization part – Cohort B: Progression free survival (PFS)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Escalation Part: Incidence of dose-limiting toxicity (DLT), Japan Cohort C: Incidence of DLT in Japanese participant, Expansion/Optimization part (Cohorts A1, A2 & D), AML: Proportion of participants who have a CR + CRh + CRi according to the modified AML IWG 2003 criteri, Expansion/Optimization part (Cohort B), MDS: Overall response rate (CR + CR equivalent + PR + CRL + CRh + HI) according to the IWG 2023 MDS response criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Expansion/Optimization part – Cohorts A, B and D: Recommended dose for expansion (RDE), Escalation and Expansion/Optimization parts – Cohorts A, B, C and D: Number of participants with TEAEs, Escalation and Expansion/Optimization parts – Cohorts A, B, C and D: Ctrough, Escalation and Expansion/Optimization parts – Cohorts A, B, C and D: Incidence of ADA, Escalation and Expansion/Optimization parts – Japan Cohort C, AML: Rate of CR + CRh + CRi per AML 2003 modified IWG response criteria, Escalation and expansion/Optimization parts – Japan Cohort C, MDS: CR rate and ORR rate per IWG 2023 MDS response criteria for escalation part and ORR rate per IWG 2023, Escalation and Expansion/Optimization parts – Japan Cohort C, B-ALL: Rate of CR + CRh + CRi as defined by National Comprehensive Cancer Network (NCCN), Expansion/Optimization part – Cohorts A and D: Overall response rate (ORR), Expansion/Optimization part – Cohorts A and D: Duration of CR + CRh + CRi (Duration of CRc), Expansi | — |
Countries
France, Netherlands