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NCT01871727 · ClinicalTrials.gov registry record · Phase 3
A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma
A Phase 3 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 3
- Development phase
- 112
- Enrollment target
NCT01871727: Completed Phase 3 study, sponsored by Eisai.
NCT01871727 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 112 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01871727, a Phase 3 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 112 participants
- Enrollment target
Study Summary
The purpose of this trial is to assess the efficacy of E7777 in participants with recurrent or persistent Cutaneous T-Cell Lymphoma (CTCL) in Stage I - III participants as assessed by objective response rate (ORR). A lead-in dose-finding part was used to determine dose level 9 microgram per kilogram (mcg/kg) E7777 that is being used to test efficacy and safety.
Primary Outcome
DLTs as per NCI CTCAE v4.03 were defined as 1) serious infusion reaction (CTCAE) Grade 4 adverse event of "Infusion related reaction," or recurrent CTCAE Grade 3 despite administration of systemic steroid premedication after initial occurrence. Infusion reactions were defined as symptoms (example, fatigue, nausea, vomiting, arthralgia, myalgia, pyrexia, chills, rigors) occurring within 24 hours of E7777 infusion. 2) Capillary leak syndrome (CLS) CTCAE Grade 4 or Grade 3 (with exceptions). A CLS
Interventions
- DRUG E7777 9 mcg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2013-05-30 |
| Est. Completion | 2021-12-14 |
| Phase | Phase 3 |
What the finished NCT01871727 record still lists
NCT01871727 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which E7777 9 mcg/kg is the first listed.
NCT01871727 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01871727 about?
NCT01871727 is a clinical study titled "A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma". The purpose of this trial is to assess the efficacy of E7777 in participants with recurrent or persistent Cutaneous T-Cell Lymphoma (CTCL) in Stage I - III participants as assessed by objective response rate (ORR). A lead-in dose-finding part was used to determine dose level 9 microgram per kilogram...
What is the current status of trial NCT01871727?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 112 participants. The study started on 2013-05-30. Estimated completion is 2021-12-14.
What interventions are being tested in trial NCT01871727?
The interventions under investigation include: E7777 9 mcg/kg (DRUG).
Who is sponsoring clinical trial NCT01871727?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01871727's enrollment target sits among peer trials
112 1652nd of 2000 higher than 346 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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