Tacrolimus/Methotrexate/Ruxolitinib vs Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil for Graft-versus-Host Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine which treatment better prevents graft-versus-host disease, a condition where donated cells attack the recipient's body after a stem cell transplant. It compares two treatment combinations: one with Tacrolimus, Methotrexate, and Ruxolitinib (a Janus kinase inhibitor), and another with Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil. Ideal participants have conditions such as acute leukemia or certain types of lymphoma and are planning a specific type of stem cell transplant. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that treatment with any investigational medications is not allowed during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of Tacrolimus, Methotrexate, and Ruxolitinib is generally well-tolerated for preventing graft-versus-host disease (GVHD). One study found that taking Ruxolitinib at a dose of 5 mg twice a day with Tacrolimus and Methotrexate is safe and effective. Patients reported it as helpful in protecting against GVHD without major safety issues.
Other studies have demonstrated that Ruxolitinib is safe during and after hematopoietic cell transplantation, a procedure to replace damaged bone marrow. It was associated with low rates of serious side effects.
These findings suggest that the treatment is likely safe for most people, based on previous research and patient experiences. However, individual reactions can vary, so discussing any concerns with the medical team running the trial is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Tacrolimus/Methotrexate/Ruxolitinib for graft-versus-host disease because it combines the strengths of three potent drugs in a novel way. Unlike standard treatments like cyclophosphamide, mycophenolate mofetil, and tacrolimus, this combination includes Ruxolitinib, a JAK inhibitor that targets specific cellular pathways involved in inflammation and immune response. This mechanism may offer more effective control of the disease with fewer side effects. Additionally, by using Tacrolimus and Methotrexate together with Ruxolitinib, the treatment could potentially reduce the severity and duration of symptoms faster than current options.
What evidence suggests that this trial's treatments could be effective for graft-versus-host disease?
In this trial, participants will receive different treatment combinations for graft-versus-host disease (GVHD). One group will receive Tacrolimus, Methotrexate, and Ruxolitinib, a combination that previous studies have shown to be promising. Research indicates that adding Ruxolitinib to Tacrolimus and Methotrexate is effective and safe for preventing GVHD, with an overall response rate of up to 85% in some cases. Another group will receive Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil. Tacrolimus and Methotrexate are already known for their roles in managing GVHD after transplantation, and Ruxolitinib is especially noted for its success in treating GVHD that doesn't respond to other treatments. This suggests that the Tacrolimus, Methotrexate, and Ruxolitinib combination could be a strong option for managing GVHD symptoms.12346
Who Is on the Research Team?
Incyte Medical Monitor
Principal Investigator
Incyte Corporation
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- Methotrexate
- Mycophenolate mofetil
- Ruxolitinib
- Tacrolimus
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
National Cancer Institute (NCI)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Blood and Marrow Transplant Clinical Trials Network
Collaborator