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NCT05313243 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed/Refractory T-cell Lymphoma
A Phase 2 study of T-Cell Lymphoma, sponsored by Yale University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 2
- Study locations
NCT05313243: Recruiting Phase 2 study of T-Cell Lymphoma, sponsored by Yale University.
NCT05313243 is a Phase 2 study of T-Cell Lymphoma that is actively recruiting participants, run by Yale University. The registered enrollment target is 32 participants, below the 132-participant average among 15 other T-Cell Lymphoma trials with a reported enrollment target (76% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05313243, a Phase 2 study of T-Cell Lymphoma, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a single arm, open label, multicenter study phase 2 study of pembrolizumab and brentuximab in subjects with relapsed/refractory CD30 positive T-cell lymphoma (including peripheral T-cell lymphoma and cutaneous T-cell lymphoma) who have received at least one prior therapy. We hypothesize that this combination is effective and will produce an overall response rate of \~55%. Pembrolizumab and brentuximab will be administered for 16 cycles in subjects with responsive disease. Pembrolizumab will be continued for an additional 19 cycles (total 35 cycles). Response assessments will occur at pre-specified intervals. For the primary endpoint the response assessment after 3 cycles will be taken into consideration. Dose adjustments for specific toxicities with either drug are detailed in the protocol. Based on statistical analysis 32 subjects will need to be accrued to evaluate for disease response based on historical control.
Primary Outcome
As assessed by the Lugano criteria for PTCL(16) and the global response score for CTCL(17)
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Brentuximab vedotin
Study Locations (2)
Connecticut
- Yale Smilow Cancer Hospital - New Haven
Massachusetts
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2023-07-10 |
| Est. Completion | 2028-07-30 |
| Phase | Phase 2 |
What NCT05313243 shows while recruiting
NCT05313243 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 132-participant average among 15 other T-Cell Lymphoma trials with a reported enrollment target (76% lower).
The record links to 1 condition, with T-Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT05313243 reports a single indexed study location in Connecticut, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05313243 about?
NCT05313243 is a clinical study titled "Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed/Refractory T-cell Lymphoma". This is a single arm, open label, multicenter study phase 2 study of pembrolizumab and brentuximab in subjects with relapsed/refractory CD30 positive T-cell lymphoma (including peripheral T-cell lymphoma and cutaneous T-cell lymphoma) who have received at least one prior therapy. We hypothesize that...
What is the current status of trial NCT05313243?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2023-07-10. Estimated completion is 2028-07-30.
What conditions does trial NCT05313243 study?
This clinical trial studies the following conditions: T-Cell Lymphoma.
What interventions are being tested in trial NCT05313243?
The interventions under investigation include: Pembrolizumab (DRUG), Brentuximab vedotin (DRUG).
Who is sponsoring clinical trial NCT05313243?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05313243 being conducted?
This trial has 2 study locations across Connecticut, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for T-Cell Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05313243's enrollment target sits among peer trials
32 8th of 15 higher than 8 of 15 other T-Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other T-Cell Lymphoma 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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