At a glance
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Phase 1b/2 Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia
In Brief
A Phase 1 clinical trial evaluating Carfilzomib, Dexamethasone, and 9 other interventions for Acute Lymphoblastic Leukemia (ALL). Completed, enrolled 141 participants across 122 sites in 33 countries.
Detailed Summary
The purpose of Phase 1b of this study is to: * Asses the safety, tolerability and activity of carfilzomib, alone and in combination with induction chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia (ALL). * Determine the maximum tolerated dose (MTD) and to recommend a phase 2 dose of carfilzomib in combination with induction chemotherapy. The purpose of Phase 2 of this study is to compare the rate of complete remission (CR) of carfilzomib in combination with vincristine, dexamethasone, PEG asparaginase, daunorubicin (VXLD) at the end of induction therapy to an appropriate external control.