Duvelisib for preventing cytokine release syndrome in CAR T-cell therapy patients
Official title: Phase III, Multicenter, Randomized, Double-Blind Study of Duvelisib as Cytokine Release Syndrome Prophylaxis in Patients with Large Cell or Mantle Cell Lymphoma Undergoing CAR T-Cell Therapies
Funded at Washington University · NIH-11374443 · Data updated 2026-11-12
A study tests whether taking duvelisib before CAR T-cell therapy can prevent dangerous inflammatory reactions in patients with large B-cell or mantle cell lymphoma.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Washington University NIH-funded |
| Lab location | 1 site (Saint Louis, United States) |
| Project start | August 8, 2011 |
| Project end | June 30, 2031 |
| Funding year | 2026 |
| Award (this year) | $232,477 |
| NIH project number | 5UG1HL109137-16 |
| Project ID | NIH-11374443 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with large B-cell lymphoma or mantle cell lymphoma planned for CAR T-cell therapy.
✕Less likely to help
Patients who do not develop CRS or do not receive CAR T-cell therapy may not benefit from this intervention.
What this research studies
This trial aims to reduce cytokine release syndrome (CRS), a common and serious complication of CAR T-cell therapy, by prophylactically administering duvelisib. It involves multiple centers and uses a randomized, double-blind design to compare duvelisib against a placebo in patients undergoing CAR T-cell treatment. Participants would be adults with certain lymphomas who are planned to receive CAR T-cells, and would be monitored for CRS severity, safety, and early outcomes after therapy. Results could help determine if a preemptive treatment approach improves tolerability and outcomes of CAR T-cell therapy.
Why it matters
Potential benefit: If successful, patients may experience fewer CRS-related complications and better tolerance of CAR T-cell therapy.
How similar studies have gone: Previous approaches exist for treating CRS after it occurs, but prophylactic strategies are still being explored with varying results.
Where this research is happening
-
Washington University
Saint Louis, United States Active
Researchers
- Principal investigator: Pusic, Iskra — Washington University
- Study coordinator: Pusic, Iskra
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.