drugset / Trial / NCT06034561
Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia
Phase 2
Recruiting
50 enrolled
Cancer Institute of the State of São Paulo
Libbs Farmacêutica LTDA · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a interventional phase II study aiming to examine the complete response rate of a bortezomib-based salvage regimen in adults with refractory or relapsed acute lymphoblastic leukemia (ALL), seeking to compare outcomes with the available literature and with our historical data on relapsed/refractory ALL.
Timeline
- Start
- 2024-04-01
- Primary completion
- 2028-08
- Completion
- 2029-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | — |
| Background | Dexamethasone | Small molecule | 2 mg | Oral |
| Background | Dexamethasone | Small molecule | 20 mg/m2 | Oral |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Background | Methotrexate | Small molecule | 12 mg | Intrathecal |
| Background | Pegaspargase | Protein / enzyme biologic | 2000 iu | Intravenous |
| Background | Vincristine | Small molecule | 1.5 mg/m2 | Intravenous |