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NCT01120834 · ClinicalTrials.gov registry record · Phase 1
Study of 5-azacitidine in Combination With Vorinostat in Patients With Relapsed or Refractory Diffuse Large b Cell Lymphoma (DLBCL)
A Phase 1 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01120834 is a Phase 1 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 17 participants.
The verdict
NCT01120834, a Phase 1 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
This will be a phase I/II study of 5-azacitidine in combination with vorinostat in patients with relapsed or refractory DLBCL. Combination therapy with methyltransferase inhibitors and histone deacetylase inhibitors is highly synergistic in DLBCL cells, and both classes of drugs can also synergize powerfully with standard anti-lymphoma chemotheraputics such as doxorubicin in pre-clinical studies. We hypothesize that azacytidine + vorinostat combination therapy will be safe and effective in selected patients with relapsed or refractory DLBCL. We also hypothesize that patients demonstrating objective responses to this combination therapy display specific epigenetic signatures, and that a biomarker or gene classifier can be generated which will identify those patients likely to respond.
Interventions
- DRUG vorinostat
- DRUG azacytidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2010-09 |
| Est. Completion | 2016-10-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01120834
The ClinicalTrials.gov registry entry for NCT01120834 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which vorinostat is the first listed.
NCT01120834 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01120834 about?
NCT01120834 is a clinical study titled "Study of 5-azacitidine in Combination With Vorinostat in Patients With Relapsed or Refractory Diffuse Large b Cell Lymphoma (DLBCL)". This will be a phase I/II study of 5-azacitidine in combination with vorinostat in patients with relapsed or refractory DLBCL. Combination therapy with methyltransferase inhibitors and histone deacetylase inhibitors is highly synergistic in DLBCL cells, and both classes of drugs can also synergize p...
What is the current status of trial NCT01120834?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2010-09. Estimated completion is 2016-10-20.
What interventions are being tested in trial NCT01120834?
The interventions under investigation include: vorinostat (DRUG), azacytidine (DRUG).
Who is sponsoring clinical trial NCT01120834?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
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