A Phase 3 Study Comparing Ruxolitinib/Tacrolimus/Methotrexate with Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil to Prevent Graft-Versus-Host Disease After a Stem Cell Transplant

Full Title

A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203/INCB 18424-370)

Purpose

After a stem cell transplant, some patients develop a condition called graft-versus-host disease (GVHD). This occurs when the donor’s healthy immune cells see the recipient’s normal cells as foreign and attack them.

In this study, researchers want to see if giving ruxolitinib with tacrolimus and methotrexate before and after a stem cell transplant will prevent GVHD. Ruxolitinib is already used to treat GVHD. The people in this study are getting a stem cell transplant as treatment for blood cancer.

The researchers will compare this new approach to the standard treatment, which includes cyclophosphamide, tacrolimus, and mycophenolate mofetil after transplant. If you take part in this study, you will be randomly assigned to get one of these treatments:

  • Ruxolitinib with tacrolimus and methotrexate before and after transplant
  • Cyclophosphamide, tacrolimus, and mycophenolate mofetil after transplant

Contact

For more information or to see if you can join this study, please call Dr. Miguel-Angel Perales’ office at 646-608-3757

Protocol
25-075
Phase
Phase III (phase 3)
Disease Status
Newly Diagnosed & Relapsed/Refractory
Investigator
Co-Investigators
ClinicalTrials.gov ID
NCT06615050