Risk-adapted therapy for gastrointestinal graft-versus-host disease
Project 3: Risk Adapted Clinical Trials of GVHD Treatment
This project uses blood biomarkers to sort people with gut GVHD into risk groups so steroid treatment can be personalized to reduce harm and improve outcomes.
Quick facts
| Grant type | P01 program project |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Icahn School of Medicine at Mount Sinai NIH-funded |
| Lab location | 1 site (New York, United States) |
| Project ID | NIH-11191461 on NIH RePORTER |
What this research studies
You would give blood so researchers can measure two proteins and calculate a MAP (MAGIC algorithm probability) score that reflects how much gut tissue is damaged. That MAP score groups patients into high, low, or ultra-low risk categories, and treatment teams adjust steroid intensity and other therapies based on your risk group. The project runs two clinical trials comparing standard steroid treatment to biomarker-guided, risk-adapted strategies and tracks responses, infections, quality of life, and survival. Participants have regular clinic visits and follow-up blood tests to monitor how well the personalized approach works.
Who could benefit from this research
Good fit: People who develop gastrointestinal graft-versus-host disease after an allogeneic hematopoietic cell (bone marrow) transplant are the intended candidates.
Not a fit: Patients without gastrointestinal involvement, those ineligible for transplant-related trials, or those with contraindications to the trial therapies may not benefit from this project.
Why it matters
Potential benefit: If successful, this approach could lower deaths from GI GVHD and reduce steroid-related complications by tailoring therapy to each patient’s risk.
How similar studies have performed: Preliminary work has validated the MAP biomarker tool and shown it predicts outcomes better than symptoms alone, but full biomarker-guided treatment trials are still new.
Where this research is happening
New York, United States
- Icahn School of Medicine at Mount Sinai — New York, United States (Active)
Researchers
- Principal investigator: Levine, John — Icahn School of Medicine at Mount Sinai
- Study coordinator: Levine, John
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.