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NCT02343536 · ClinicalTrials.gov registry record · Phase 1
A Phase 1, Open-label Trial of Oral Azacitidine (CC-486) Plus RCHOP in Subjects With Large B-Cell Lymphoma or Follicular Lymphoma or Transformed Lymphoma
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
NCT02343536: Completed Phase 1 study, sponsored by Celgene.
NCT02343536 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 59 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02343536, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
Study Summary
The goal of the study is to identify a dose and schedule of CC-486 that can be safely administered with R-CHOP. To evaluate the safety and maximum tolerated dose (MTD) or the maximal administered dose (MAD) of CC-486 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in subjects with high risk (IPI 2 or more) previously untreated DLBCL or Grade 3B FL. Also, to determine pharmacokinetics (PK) of CC-486 when administered alone and in combination with R-CHOP and to explore preliminary efficacy of CC-486 plus R-CHOP by 2007 International Working Group (IWG) criteria.
Primary Outcome
The dose level corresponding to the target Dose Limiting Toxicity (DLT) probability of 0.20.
Interventions
- DRUG Rituximab
- DRUG Vincristine
- DRUG Prednisone
- DRUG cyclophosphamide
- DRUG Oral Azacitidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2015-04-29 |
| Est. Completion | 2020-01-29 |
| Phase | Phase 1 |
What the finished NCT02343536 record still lists
NCT02343536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Rituximab is the first listed.
NCT02343536 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02343536 about?
NCT02343536 is a clinical study titled "A Phase 1, Open-label Trial of Oral Azacitidine (CC-486) Plus RCHOP in Subjects With Large B-Cell Lymphoma or Follicular Lymphoma or Transformed Lymphoma". The goal of the study is to identify a dose and schedule of CC-486 that can be safely administered with R-CHOP. To evaluate the safety and maximum tolerated dose (MTD) or the maximal administered dose (MAD) of CC-486 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and pred...
What is the current status of trial NCT02343536?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2015-04-29. Estimated completion is 2020-01-29.
What interventions are being tested in trial NCT02343536?
The interventions under investigation include: Rituximab (DRUG), Vincristine (DRUG), Prednisone (DRUG), cyclophosphamide (DRUG), Oral Azacitidine (DRUG).
Who is sponsoring clinical trial NCT02343536?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02343536's enrollment target sits among peer trials
59 895th of 2000 higher than 1,106 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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