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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 is a Phase 1 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 14 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01004991
The ClinicalTrials.gov registry entry for NCT01004991 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 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 5 interventions - of which prednisone is the first listed.
NCT01004991 reports 0 study locations.
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.
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