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NCT01312818 · ClinicalTrials.gov registry record · Phase 2
Bortezomib, Vorinostat and Dexamethasone for Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)
A Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT01312818: Clinical Trial Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT01312818 is a Phase 2 study that was terminated before completion, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01312818, a Phase 2 study, was terminated before completion, sponsored by Masonic Cancer Center, University of Minnesota.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study 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.
Primary Outcome
Complete Remission (CR): A CR requires that the following be recorded concurrently: an absolute neutrophil count (segs and bands) \> 1000/μL, no circulating blasts, platelets \> 100,000/μL; adequate bone marrow cellularity with trilineage hematopoiesis, and \< 5% marrow leukemia blast cells. All previous extramedullary manifestations of disease must be absent. If patients continue on with treatment, there can be no evidence of recurrence of ALL for at least 4 weeks.
Interventions
- DRUG Dexamethasone
- DRUG Bortezomib
- DRUG Vorinostat
- DRUG Methotrexate
- DRUG Imatinib mesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
Why NCT01312818 stopped before completion
NCT01312818 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which Dexamethasone is the first listed.
NCT01312818 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01312818 about?
NCT01312818 is a clinical study titled "Bortezomib, Vorinostat and Dexamethasone for Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)". 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 di...
What is the current status of trial NCT01312818?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2011-06. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01312818?
The interventions under investigation include: Dexamethasone (DRUG), Bortezomib (DRUG), Vorinostat (DRUG), Methotrexate (DRUG), Imatinib mesylate (DRUG).
Who is sponsoring clinical trial NCT01312818?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01312818's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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