B-Cell Pediatric ALL Clinical Trial
Official title:
A Phase 2, Multicenter, Single-arm Study of Moxetumomab Pasudotox in Pediatric Subjects With Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma of B-cell Origin
The primary objective of this study is to evaluate the efficacy of moxetumomab pasudotox in pediatric subjects with relapsed or refractory B-cell ALL or B-cell lymphoblastic lymphoma
This is a global, multicenter, open-label, single-arm Phase 2 study to evaluate the efficacy and safety of moxetumomab pasudotox monotherapy in pediatric subjects with relapsed or refractory B-cell ALL or B-cell lymphoblastic lymphoma. Subjects will be enrolled at sites in North America, Europe, and Australia. This is an approximate 35-month study. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment