Ruxolitinib for GVHD Prevention

Phase 2a Study of Adding Ruxolitinib With Tacrolimus/Methotrexate Regimen for Graft-versus-Host Disease Prophylaxis in Myeloablative Conditioning Hematopoietic Cell Transplantation in Pediatric and Young Adult Patients

What's the purpose of the trial?

This phase II trial tests how well ruxolitinib with tacrolimus and methotrexate work to prevent the development of graft versus host disease in pediatric and young adult patients undergoing allogeneic hematopoietic cell transplant for acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Ruxolitinib is a type of medication called a kinase inhibitor. It works by blocking the signals of cells that cause inflammation and cell proliferation, which may help prevent graft versus host disease (GVHD). Tacrolimus is a drug used to help reduce the risk of rejection by the body of organ and bone marrow transplants by suppressing the immune system. Methotrexate stops cells from making DNA, may kill cancer cells, and also suppress the immune system, which may reduce the risk of GVHD. Giving ruxolitinib with tacrolimus and methotrexate may prevent GVHD in pediatric and young adults undergoing allogeneic hematopoietic cell transplants.
Trial status

Accepting patients

Phase
Phase 2
Enrollment
40
Last Updated
1 month ago
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Participating Centers

There is one center participating in this trial. Enter a location below to view the distance.

Experimental Treatments

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  • Allogeneic Stem Cell Transplant is a type of stem cell transplant that utilizes a donor's pre-collected stem cells to rescue the bone marrow from the toxic effects of very high dose chemotherapy.
  • Methotrexate is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Ruxolitinib is a tyrosine kinase inhibitor in development for the treatment of several different blood cancers.
  • Tacrolimus is an immunosuppressive medication used to help prevent rejection in patients who have had a transplant.

Arms / Cohorts

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Accepting patients

Ruxolitinib + Tacrolimus + Methotrexate

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