Tacrolimus/Methotrexate/Ruxolitinib vs Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil for Graft-versus-Host Disease
Trial Summary
What is the purpose of this trial?
The purpose of this study is to assess Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation
Research Team
Incyte Medical Monitor
Principal Investigator
Incyte Corporation
Eligibility Criteria
This trial is for adults over 18 with certain blood cancers like acute leukemia, myelodysplasia, or lymphoma without high levels of cancer cells in the blood or bone marrow. They must have a functioning heart and kidneys. Participants need a sibling or unrelated donor who matches specific genetic markers and agrees to donate stem cells.Inclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Conditioning
Participants undergo non-myeloablative/reduced intensity conditioning prior to transplantation
Transplantation
Participants receive allogeneic peripheral blood stem cell transplantation
Treatment
Participants receive Tacrolimus/Methotrexate/Ruxolitinib or Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cyclophosphamide (Alkylating agents)
- Methotrexate (Antimetabolites)
- Mycophenolate mofetil (Immunosuppressant)
- Ruxolitinib (JAK Inhibitor)
- Tacrolimus (Immunosuppressant)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Incyte Corporation
Lead Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School
National Institutes of Health (NIH)
Collaborator
Dr. Jeanne Marrazzo
National Institutes of Health (NIH)
Chief Medical Officer
MD from University of California, Los Angeles
Dr. Jay Bhattacharya
National Institutes of Health (NIH)
Chief Executive Officer
MD, PhD from Stanford University
National Cancer Institute (NCI)
Collaborator
Dr. Douglas R. Lowy
National Cancer Institute (NCI)
Chief Executive Officer since 2023
MD from New York University School of Medicine
Dr. Monica Bertagnolli
National Cancer Institute (NCI)
Chief Medical Officer since 2022
MD from Harvard Medical School
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Dr. Gary H. Gibbons
National Heart, Lung, and Blood Institute (NHLBI)
Chief Executive Officer since 2012
MD from Harvard Medical School
Dr. James P. Kiley
National Heart, Lung, and Blood Institute (NHLBI)
Chief Medical Officer since 2011
MD from University of California, San Francisco
Blood and Marrow Transplant Clinical Trials Network
Collaborator