Relapsed/refractory B-cell Acute Lymphoblastic Leukemia
Conditions
Brief summary
Part 1: Complete remission (CR) within the first 3 treatment cycles, Part 1: Number of participants with an adverse event (AE), Part 1: Number of participants discontinuing from study therapy due to AE, Part 2: Percentage of participants with CR within the first 3 treatment cycles, Part 2: Overall survival (OS)
Detailed description
Part 1: OS, Part 1: Percentage of participants with minimal residual disease (MRD) negativity within the first 3 treatment cycles, Part 1: Percentage of participants with CR, complete remission with partial hematologic recovery (CRh), or complete remission with incomplete count recovery (CRi) within the first 3 treatment cycles, Part 2: Percentage of participants with MRD negativity within the first 3 treatment cycles, Part 2: Percentage of participants with CR or CRh within the first 3 treatment cycles, Part 2: Percentage of participants with CR, CRh, or CRi within the first 3 treatment cycles, Part 2: Duration of CR, Part 2: Duration of CR/CRh, Part 2: Duration of CR, CRh, or CRi, Part 2: Event free survival (EFS), Part 2: Percentage of participants who undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT), Part 2: Percentage of participants who experienced an adverse event (AE), Part 2: Percentage of participants who discontinued study intervention due to an AE
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Complete remission (CR) within the first 3 treatment cycles, Part 1: Number of participants with an adverse event (AE), Part 1: Number of participants discontinuing from study therapy due to AE, Part 2: Percentage of participants with CR within the first 3 treatment cycles, Part 2: Overall survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: OS, Part 1: Percentage of participants with minimal residual disease (MRD) negativity within the first 3 treatment cycles, Part 1: Percentage of participants with CR, complete remission with partial hematologic recovery (CRh), or complete remission with incomplete count recovery (CRi) within the first 3 treatment cycles, Part 2: Percentage of participants with MRD negativity within the first 3 treatment cycles, Part 2: Percentage of participants with CR or CRh within the first 3 treatment cycles, Part 2: Percentage of participants with CR, CRh, or CRi within the first 3 treatment cycles, Part 2: Duration of CR, Part 2: Duration of CR/CRh, Part 2: Duration of CR, CRh, or CRi, Part 2: Event free survival (EFS), Part 2: Percentage of participants who undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT), Part 2: Percentage of participants who experienced an adverse event (AE), Part 2: Percentage of participants who discontinued study intervention due to an AE | — |