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NCT01004991 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Trial of R-CHOP + Azacytidine in Diffuse Large B Cell Lymphoma
A Phase 1 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT01004991: Completed Phase 1 study, sponsored by Weill Medical College of Cornell University.
NCT01004991 is a Phase 1 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01004991, a Phase 1 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This is a phase I/II open label, multi-center study of azacytidine in combination with standard RCHOP therapy in patients with DLBCL. Patients will be treated with azacytidine at escalating doses on days 1-5, followed by standard dose rituximab plus CHOP chemotherapy on day 8, every 21 days. Patients will be treated for a total 6 cycles. The phase II portion will then evaluate efficacy of the combination at the established MTD.
Primary Outcome
Complete Response
Interventions
- DRUG prednisone
- DRUG cyclophosphamide
- BIOLOGICAL rituximab
- DRUG doxorubicin
- DRUG vincristine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2010-01 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
What the finished NCT01004991 record still lists
NCT01004991 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 5 interventions - of which prednisone is the first listed.
NCT01004991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01004991 about?
NCT01004991 is a clinical study titled "Phase I/II Trial of R-CHOP + Azacytidine in Diffuse Large B Cell Lymphoma". This is a phase I/II open label, multi-center study of azacytidine in combination with standard RCHOP therapy in patients with DLBCL. Patients will be treated with azacytidine at escalating doses on days 1-5, followed by standard dose rituximab plus CHOP chemotherapy on day 8, every 21 days. Patient...
What is the current status of trial NCT01004991?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2010-01. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01004991?
The interventions under investigation include: prednisone (DRUG), cyclophosphamide (DRUG), rituximab (BIOLOGICAL), doxorubicin (DRUG), vincristine (DRUG).
Who is sponsoring clinical trial NCT01004991?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01004991's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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