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NCT03542266 · ClinicalTrials.gov registry record · Phase 2
CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
A Phase 2 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT03542266: Completed Phase 2 study, sponsored by Weill Medical College of Cornell University.
NCT03542266 is a Phase 2 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03542266, a Phase 2 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
This is a phase II, multi-center study to determine the efficacy and safety of first-line CC-486 plus CHOP in patients with PTCL who have received no prior systemic therapy. The study has a sample size of 20, and follows two-stage minimax design for primary efficacy analysis.
Primary Outcome
Complete response rate (CR) of CC486-CHOP in PTCL by Lugano Criteria for target lesions, and the Deauville Criteria (5 point scale) assessed by PET or CT; CR (complete metabolic or radiologic response) defined as Deauville score of 1, 2 or 3 by PET or regression of all target lesions to \< 1.5cm in longest diameter by CT.
Interventions
- DRUG CC-486 Administration
- DRUG CHOP Administration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-06-01 |
| Est. Completion | 2022-07-25 |
| Phase | Phase 2 |
What the finished NCT03542266 record still lists
NCT03542266 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which CC-486 Administration is the first listed.
NCT03542266 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03542266 about?
NCT03542266 is a clinical study titled "CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma". This is a phase II, multi-center study to determine the efficacy and safety of first-line CC-486 plus CHOP in patients with PTCL who have received no prior systemic therapy. The study has a sample size of 20, and follows two-stage minimax design for primary efficacy analysis.
What is the current status of trial NCT03542266?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2018-06-01. Estimated completion is 2022-07-25.
What interventions are being tested in trial NCT03542266?
The interventions under investigation include: CC-486 Administration (DRUG), CHOP Administration (DRUG).
Who is sponsoring clinical trial NCT03542266?
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 NCT03542266's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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