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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05313243
The ClinicalTrials.gov registry entry for NCT05313243 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 132-participant average among 15 other T-Cell Lymphoma trials with a reported enrollment target (76% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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