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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 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 59 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02343536
The ClinicalTrials.gov registry entry for NCT02343536 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Rituximab is the first listed.
NCT02343536 reports 0 study locations.
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.
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