Preventing graft-versus-host disease after donor stem cell transplant with sitagliptin, bortezomib, and post-transplant cyclophosphamide
Phase I/II trial of sitagliptin, bortezomib and post-transplant cyclophosphamide for GvHD prophylaxis; IND 158327 (09/03/2021)
This trial adds sitagliptin and bortezomib to post-transplant cyclophosphamide to try to reduce acute and chronic graft-versus-host disease in people receiving donor stem cell transplants.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Feinstein Institute for Medical Research NIH-funded |
| Lab location | 1 site (Manhasset, United States) |
| Project ID | NIH-10930876 on NIH RePORTER |
What this research studies
You would receive the usual post-transplant cyclophosphamide plus the oral drug sitagliptin and the injection drug bortezomib for a short period after your donor stem cell transplant. The Phase I part finds safe dosing and watches for side effects, and the Phase II part looks at whether the combination lowers rates of acute and chronic GvHD without increasing relapse. Doctors will monitor you closely with blood tests, clinic visits, and exams to check immune recovery, infections, and signs of GvHD. The goal is a shorter, safer regimen that prevents GvHD while preserving the transplant's cancer-fighting effects.
Who could benefit from this research
Good fit: Adults undergoing allogeneic hematopoietic stem cell transplantation who meet the trial's medical and eligibility criteria are the intended participants.
Not a fit: People who are not having an allogeneic stem cell transplant, who have contraindications to sitagliptin, bortezomib, or cyclophosphamide, or who do not meet trial eligibility are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could lower rates of acute and chronic GvHD after transplant, improving survival and quality of life.
How similar studies have performed: Post-transplant cyclophosphamide has been linked to low rates of chronic GvHD in prior trials and bortezomib has shown promise in smaller studies, but this specific three-drug combination is a newer approach being tested.
Where this research is happening
Manhasset, United States
- Feinstein Institute for Medical Research — Manhasset, United States (Active)
Researchers
- Principal investigator: Al-Homsi, Ahmad Samer — Feinstein Institute for Medical Research
- Study coordinator: Al-Homsi, Ahmad Samer
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.