Preventing a serious side effect of CAR T-cell therapy for lymphoma
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
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 ID | NIH-11166414 on NIH RePORTER |
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.
Who could benefit from this research
Good fit: Ideal candidates are adults aged 21 and older with large cell or mantle cell lymphoma who are scheduled to undergo CAR T-cell therapy.
Not a fit: 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.
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 performed: 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
Saint Louis, United States
- Washington University — Saint Louis, United States (Active)
Researchers
- Principal investigator: Pusic, Iskra — Washington University
- Study coordinator: Pusic, Iskra
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 below.