Why are we doing this research?
The purpose of the study is to determine the maximum tolerated dose and assess the safety, tolerability and activity of carfilzomib, alone and in combination with induction chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia (ALL).
EXPERIMENTAL: DOSE ESCALATION 1
- Subjects will receive carfilzomib in combination with induction chemotherapy, comprising either an R3 backbone of dexamethasone, mitoxantrone, PEG asparaginase, and vincristine (Dose Escalation 1) or a VXLD backbone of vincristine, dexamethasone, PEG asparaginase, and daunorubicin (Dose Escalation 2).
- Subjects participating in the Dose Escalation 1 (R3) portion of the study will have a 1 week carfilzomib single agent Lead in Window prior to the Induction Cycle. Subjects in both dose escalation portions of the study will receive a 4 week cycle of induction chemotherapy and have the option to receive a 4 week cycle of consolidation chemotherapy (Children's Oncology Group (COG) modified Berlin Frankfurt Münster (BFM) chemotherapy backbone (6 mercaptopurine, cyclophosphamide, cytarabine, PEG asparaginase, vincristine), if stable disease or better response is achieved at the end of the Induction Cycle.
Study Type: Interventional
Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
AGES ELIGIBLE FOR STUDY: Child, Adult, Senior