Overview

Four Drug Reinduction With Bortezomib for Relapsed or Refractory ALL or LL in Children and Young Adults

Status:
Terminated
Trial end date:
2017-05-25
Target enrollment:
Participant gender:
Summary
This is a phase II study designed to investigate the combination of bortezomib with the mitoxantrone reinduction regimen used in the ALL R3 trial. The study will enroll patients with high risk ALL relapse including early bone marrow relapse and second or greater relapse of any kind. Patients with relapsed LL will also be eligible. Bone marrow evaluation will be performed after blood counts recover to assess the rate of CR (<5% bone marrow blasts) and MRD status in children following this regimen. Further treatment with or without HSCT will be at the discretion of the primary physician.
Phase:
Phase 2
Details
Lead Sponsor:
Children's Mercy Hospital Kansas City
Collaborator:
Millennium Pharmaceuticals, Inc.
Treatments:
BB 1101
Bortezomib
Cortisol succinate
Cytarabine
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Methotrexate
Mitoxantrone
Pegaspargase
Vincristine