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NCT04601831 · ClinicalTrials.gov registry record · Phase 1
'Re-Priming' RT After Incomplete Response to CAR-T in R/R NHL
A Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT04601831 is a Phase 1 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 14 participants.
The verdict
NCT04601831, a Phase 1 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This is a single-arm open-label phase I/II trial studying the safety and efficacy of focal 're-priming' radiation therapy (RT) to FDG-avid residual sites of disease in relapsed/refractory non-Hodgkin lymphoma (R/R NHL) patients with incomplete response (IR) to CAR T-cell therapy (CAR-T) by day 30 post-CAR-T PET/CT. We hypothesize that focal 're-priming' RT will be safe (phase I) and improve conversion to metabolic complete response (CR) by day 90 post-CAR-T PET/CT from 29% (historical control) to 58% (phase II).
Interventions
- RADIATION Focal radiation therapy (RT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2020-12-23 |
| Est. Completion | 2025-05-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04601831
The ClinicalTrials.gov registry entry for NCT04601831 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Focal radiation therapy (RT) is the first listed.
NCT04601831 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04601831 about?
NCT04601831 is a clinical study titled "'Re-Priming' RT After Incomplete Response to CAR-T in R/R NHL". This is a single-arm open-label phase I/II trial studying the safety and efficacy of focal 're-priming' radiation therapy (RT) to FDG-avid residual sites of disease in relapsed/refractory non-Hodgkin lymphoma (R/R NHL) patients with incomplete response (IR) to CAR T-cell therapy (CAR-T) by day 30 po...
What is the current status of trial NCT04601831?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2020-12-23. Estimated completion is 2025-05-27.
What interventions are being tested in trial NCT04601831?
The interventions under investigation include: Focal radiation therapy (RT) (RADIATION).
Who is sponsoring clinical trial NCT04601831?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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