B-Cell Acute Lymphoblastic Leukaemia
Conditions
Brief summary
Part A: Frequency of DLTs, Part A,B Safety Evaluation of AZD0486, Part B, C: Rate of CR within 3 cycles
Detailed description
Part A: Rate of CR within 3 cycles, Part A,B,C: Rate of CR/CRh and CR/CRh/CRi within 3 cycles, Part A,B,C: Rate of CR, CR/CRh and CR/CRh/CRi at any time during study, Part A, B, C: Duration of CR, CR/CRh and CR/CRh/CRi, Part A, B, C: Event-free survival (EFS), Part A, B, C: Overall Survival (OS), Part B, C: Subsequent alloSCT or donor lymphocyte infusion if used as an alloSCT substitute, Part A, B, C: MRD-negative rate of CR, CR/CRh and CR/CRh/CRi, Part A, B, C: PK Characterization of AZD0486 (UC, Cmax, tmax, Ctrough, t1/2 and CL of AZD0486), Part A, B, C: ADA Characterization of AZD0486
Interventions
DRUGAZD0486
DRUGTOCILIZUMAB
Sponsors
Astrazeneca AB
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Frequency of DLTs, Part A,B Safety Evaluation of AZD0486, Part B, C: Rate of CR within 3 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: Rate of CR within 3 cycles, Part A,B,C: Rate of CR/CRh and CR/CRh/CRi within 3 cycles, Part A,B,C: Rate of CR, CR/CRh and CR/CRh/CRi at any time during study, Part A, B, C: Duration of CR, CR/CRh and CR/CRh/CRi, Part A, B, C: Event-free survival (EFS), Part A, B, C: Overall Survival (OS), Part B, C: Subsequent alloSCT or donor lymphocyte infusion if used as an alloSCT substitute, Part A, B, C: MRD-negative rate of CR, CR/CRh and CR/CRh/CRi, Part A, B, C: PK Characterization of AZD0486 (UC, Cmax, tmax, Ctrough, t1/2 and CL of AZD0486), Part A, B, C: ADA Characterization of AZD0486 | — |
Countries
France, Germany, Italy, Spain
Outcome results
None listed