B-cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL).
Conditions
Brief summary
B ALL Cohort: Proportion of pediatric participants with r/r B ALL at screening who achieve CR within 3 months of obe-cel infusion per IRRC assessment, B ALL Cohort: Proportion of pediatric participants with r/r B ALL at screening who achieve ORR (CR + CRi) within 3 months of obe-cel infusion per IRRC assessment, B ALL and B NHL Cohorts: Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) after receiving obe-cel infusion, B ALL and B NHL Cohorts: Incidence and duration of severe hypogammaglobulinemia
Detailed description
B-ALL Cohort (Key Secondary): Proportion of pediatric participants with r/r B ALL with successful ClonoSEQ® NGS MRD calibration who achieve MRD-negative ORR below the 10-4 level (< 0.01%) within 3 months of obe-cel infusion per IRRC assessment, B-NHL Cohort (Secondary): • ORR (CR + PR) • Duration of response (DoR); • Progression free survival (PFS); • Overall survival (OS); • Incidence of CD19-negative relapse., B ALL Cohort (Secondary): • CR at any time • ORR (CR + CRi) at any time • MRD-negative ORR below the 10-4 level (< 0.01%) at any time • Duration of Remission (DoR) • Event Free Survival (EFS) • Overall Survival (OS) • Proportion of participants undergoing HSCT while still in CR/CRi following obe-cel • Incidence of CD19-negative relapse at any time
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| B ALL Cohort: Proportion of pediatric participants with r/r B ALL at screening who achieve CR within 3 months of obe-cel infusion per IRRC assessment, B ALL Cohort: Proportion of pediatric participants with r/r B ALL at screening who achieve ORR (CR + CRi) within 3 months of obe-cel infusion per IRRC assessment, B ALL and B NHL Cohorts: Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) after receiving obe-cel infusion, B ALL and B NHL Cohorts: Incidence and duration of severe hypogammaglobulinemia | — |
Secondary
| Measure | Time frame |
|---|---|
| B-ALL Cohort (Key Secondary): Proportion of pediatric participants with r/r B ALL with successful ClonoSEQ® NGS MRD calibration who achieve MRD-negative ORR below the 10-4 level (< 0.01%) within 3 months of obe-cel infusion per IRRC assessment, B-NHL Cohort (Secondary): • ORR (CR + PR) • Duration of response (DoR); • Progression free survival (PFS); • Overall survival (OS); • Incidence of CD19-negative relapse., B ALL Cohort (Secondary): • CR at any time • ORR (CR + CRi) at any time • MRD-negative ORR below the 10-4 level (< 0.01%) at any time • Duration of Remission (DoR) • Event Free Survival (EFS) • Overall Survival (OS) • Proportion of participants undergoing HSCT while still in CR/CRi following obe-cel • Incidence of CD19-negative relapse at any time | — |
Countries
Spain