Preventing a serious side effect of CAR T-cell therapy for lymphoma
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-11166414 · Data updated 2026-11-12
This project is testing a new medication called Duvelisib to help prevent a serious immune reaction called cytokine release syndrome in people with large cell or mantle cell lymphoma who are receiving CAR T-cell therapy.
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 | 2025 |
| Award (this year) | $232,941 |
| NIH project number | 5UG1HL109137-15 |
| Project ID | NIH-11166414 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are adults aged 21 and older with large cell or mantle cell lymphoma who are scheduled to undergo CAR T-cell therapy.
✕Less likely to help
Patients who are not receiving CAR T-cell therapy for large cell or mantle cell lymphoma would not directly benefit from this specific prevention approach.
What this research studies
For patients with large cell or mantle cell lymphoma receiving CAR T-cell therapy, a severe immune reaction called cytokine release syndrome (CRS) can be a major challenge. This important clinical trial aims to see if a medication called Duvelisib can help prevent CRS from happening. Participants will be randomly assigned to receive either Duvelisib or a placebo, and neither they nor their doctors will know which treatment they are getting. The goal is to find a way to make CAR T-cell therapy safer and more effective by reducing the risk of this serious complication.
Why it matters
Potential benefit: If successful, this medication could offer the first FDA-approved way to prevent cytokine release syndrome, making CAR T-cell therapies safer and more accessible for lymphoma patients.
How similar studies have gone: While treatments exist for established cytokine release syndrome, this approach of using Duvelisib for prevention is novel and currently lacks FDA-approved alternatives.
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.