A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease

Description

Primary Objective:

To compare Grade 2-4 acute graft versus host disease-free survival (GFS) between the MMF and Ruxolitinib arms

Secondary Objectives:

To compare the following between treatment arms:

1. Grade 3-5 adverse event of this regimen as per CTCAE v5.0 criteria.
2. Graft versus host disease-free, relapse-free survival (GRFS)
3. Time to neutrophil and platelet engraftment
4. Incidence of acute and chronic GVHD
5. Relapse incidence
6. Non relapse mortality
7. Overall survival
8. Progression-free survival
9. Chimerism
10. Immunosuppression cessation time
11. Rate of graft failure

Exploratory Objective:

To conduct mechanistic studies to compare immune recovery between arms and correlate these with disease control and GVHD prophylaxis.