Phase I-II Study of PTCy, Bortezomib, and Sitagliptin for GvHD Prevention
This study is testing a combination of three drugs – post transplant cyclophosphamide (PTCy), bortezomib, and sitagliptin – to see if they can prevent graft-versus-host disease (GvHD) after an allogeneic hematopoietic stem cell transplant (HSCT). GvHD is a serious complication where the new immune cells from the donor attack the patient's body. This study is for adults with certain blood cancers (hematologic malignancies) who are undergoing a specific type of stem cell transplant. The researchers want to find the safest and most effective dose of these drugs. Success in Phase I is measured at 6 months, and in Phase II at 48 months. The current recruitment status is unclear.
- Study design
- This is an interventional, non-randomized, open-label, phase I/II study. It will enroll 72 participants and uses a 3+3 design to find the right dose.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants in Phase I will be followed for 6 months, and those in Phase II for 48 months.
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Phase I-II PTCy, Bortezomib and Sitagliptin for Prevention of GvHD Following Allogeneic HSCT
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Phase I6 months
Phase I portion is determining the MTD of sitagliptin and bortezomib in combination with PTCy. Based on 3 planned dose levels, a maximum of 18 patients are included, although testing all three dose levels is not expected to be required.
- Phase II48 months
Phase II study is the incidence of grade II-IV acute GvHD by day +100