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

Who Can Join

To join this study, there are a few conditions. You must:

  • Leukemia, Hodgkin lymphoma, or non-Hodgkin lymphoma that will be treated with a stem cell transplant.
  • Have a suitable stem cell donor.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

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