drugset / Trial / NCT02535806
Four Drug Reinduction With Bortezomib for Relapsed or Refractory ALL or LL in Children and Young Adults
Phase 2
Terminated
2 enrolled
Children's Mercy Hospital Kansas City
Millennium Pharmaceuticals, Inc. · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-07
- Primary completion
- 2017-05-25
- Completion
- 2017-05-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | — | Other |
| Background | Dexamethasone | Small molecule | 10 mg/m2 | Oral |
| Background | Hydrocortisone | Other / unclassified | — | Other |
| Background | Methotrexate | Small molecule | — | Other |
| Background | Mitoxantrone | Small molecule | 10 mg/m2 | — |
| Background | Pegaspargase | Protein / enzyme biologic | 2500 unknown | — |
| Background | Vincristine | Small molecule | 1.5 mg/m2 | — |