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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01312818
The ClinicalTrials.gov registry entry for NCT01312818 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Dexamethasone is the first listed.
NCT01312818 reports 0 study locations.
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.
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