Ustekinumab to prevent graft-versus-host disease after donor stem cell transplant
Ustekinumab for Graft versus Host Disease Prevention (IND 144540)
['FUNDING_R01'] · FRED HUTCHINSON CANCER CENTER · NIH-10891411
This trial gives the drug ustekinumab alongside usual immune-suppressing medicines to people receiving unrelated donor stem cell transplants to try to prevent graft-versus-host disease.
Quick facts
| Phase | ['FUNDING_R01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | FRED HUTCHINSON CANCER CENTER (nih funded) |
| Locations | 1 site (SEATTLE, UNITED STATES) |
| Trial ID | NIH-10891411 on ClinicalTrials.gov |
What this research studies
You would be randomly assigned to receive either ustekinumab or a placebo in addition to the standard drugs given after an unrelated donor hematopoietic cell transplant. The trial is double-blinded, so neither you nor your care team would know which treatment you receive. The main goal is to see whether people on ustekinumab have fewer moderate-to-severe acute GVHD events in the first six months after transplant, with follow-up for chronic GVHD and patient-reported outcomes through two years. The study also looks at immune markers and blood tests tied to GVHD to understand how the drug may work.
Who could benefit from this research
Good fit: Ideal candidates are adults undergoing unrelated donor allogeneic hematopoietic cell transplantation who can receive standard GVHD prophylaxis and ustekinumab per study rules.
Not a fit: People not undergoing unrelated donor allogeneic transplant (for example autologous transplant patients), or those with medical reasons they cannot take ustekinumab, are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the treatment could lower the chance of acute GVHD, improve survival and long-term quality of life after unrelated donor transplants.
How similar studies have performed: Earlier proof-of-concept clinical data showed that blocking IL-12/23p40 with ustekinumab delayed acute GVHD onset, improved survival and reduced biomarker levels, but larger randomized trials are needed to confirm benefit.
Where this research is happening
SEATTLE, UNITED STATES
- FRED HUTCHINSON CANCER CENTER — SEATTLE, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: LEE, STEPHANIE J — FRED HUTCHINSON CANCER CENTER
- Study coordinator: LEE, STEPHANIE J
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.