drugset / Trial / NCT01312818
Bortezomib, Vorinostat and Dexamethasone for Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)
Phase 2
Terminated
2 enrolled
Masonic Cancer Center, University of Minnesota
Millennium Pharmaceuticals, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
Both of bortezomib and vorinostat have identified Phase II doses for pediatric and adult patients of which no grade 4 dose limiting toxicities have been observed in prior studies. The pre-clinical synergy of these 2 agents when used in combination along with the lack of over-riding toxicities and different mechanisms of action provide strong rationale for a clinical trial investigating bortezomib and vorinostat in combination. This trial will use the identified Phase II dose which is at or below the maximum tolerated dose for both agents which have very acceptable toxicity profiles and such should prove feasible and tolerable in this relapsed/refractory ALL population.
Timeline
- Start
- 2011-06
- Primary completion
- 2013-01
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Other |
| Subject | Dexamethasone | Small molecule | 6 mg/m2 | Oral |
| Subject | Vorinostat | Small molecule | 180 mg/m2 | Oral |
| Background | Imatinib | Small molecule | 340 mg/m2 | Oral |
| Background | Imatinib | Small molecule | 400 mg | Oral |
| Background | Methotrexate | Small molecule | — | Other |