Ustekinumab to prevent graft-versus-host disease after donor stem cell transplant
Official title: Ustekinumab for Graft versus Host Disease Prevention (IND 144540)
Funded at Fred Hutchinson Cancer Center · NIH-10891411 · Data updated 2026-11-12
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
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Fred Hutchinson Cancer Center NIH-funded |
| Lab location | 1 site (Seattle, United States) |
| Project start | August 24, 2020 |
| Project end | July 31, 2027 |
| Funding year | 2025 |
| Award (this year) | $876,984 |
| NIH project number | 5R01FD006836-05 |
| Project ID | NIH-10891411 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are adults undergoing unrelated donor allogeneic hematopoietic cell transplantation who can receive standard GVHD prophylaxis and ustekinumab per study rules.
✕Less likely to help
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.
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.
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 gone: 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
-
Fred Hutchinson Cancer Center
Seattle, United States Active
Researchers
- Principal investigator: Lee, Stephanie J — Fred Hutchinson Cancer Center
- Study coordinator: Lee, Stephanie J
Related research
Other NIH-funded projects on the same topics.
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Targeting early oral GVHD to improve mouth health after stem cell transplant
A study at UW–Madison will explore why some transplant patients develop painful oral GVHD and test ideas to prevent and lessen mouth-related problems.
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Microbiome-based therapy for treatment-refractory GVHD after stem cell transplant
A microbiome-based therapy is being developed to help people who have graft-versus-host disease that doesn’t respond to standard treatments after a stem cell transplant.
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Role of altered mitochondria in preventing GVHD after stem cell transplant
This NIH grant explores how damaged mitochondria released during pre-transplant conditioning may trigger graft-versus-host disease and tests ways to fix mitochondrial dynamics to prevent GVHD.
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Fecal transplant plus fiber to treat graft-versus-host disease after blood stem cell transplant
A study to see if giving fecal transplant along with dietary fiber helps gut health and reduces complications in patients who have received a stem cell transplant and developed graft-versus-host disease.
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Using medium-chain fatty acids and a fat-sensing receptor to treat chronic graft-versus-host disease
This project looks at whether changing medium‑chain fatty acids or blocking a fat sensor called GPR84 can help people with chronic graft‑versus‑host disease after a bone marrow/stem cell transplant.
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Microbiome-based oral therapy for gut GVHD after stem cell transplant
Researchers are testing an oral live Biotherapeutic Product to help the gut microbiome improve graft-versus-host disease after stem cell transplant patients.
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.