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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: Completed Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
NCT04601831 is a Phase 1 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
To determine the dose-limiting toxicity (DLT) and maximally tolerated dose (MTD) of RT to sites of incomplete response after CAR-T in patients with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL). DLT rate will be defined by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade 4 or higher hematologic, grade 3 or higher dermatitis/burn, pneumonitis, enteritis, or other toxicity attributable to RT, as well as new grade 3 or higher cytokine release syndrome (CRS) per American Soc
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 |
What the finished NCT04601831 record still lists
NCT04601831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Focal radiation therapy (RT) is the first listed.
NCT04601831 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04601831's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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