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Ruxolitinib With Tacrolimus and Methotrexate for the Prevention 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
Sponsor: City of Hope Medical Center
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
2 Years - 22 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-07-16
Completion Date
2030-11-22
Last Updated
2025-10-31
Healthy Volunteers
No
Interventions
Biospecimen Collection
Undergo blood sample collection
Chest Computed Tomography
Undergo chest CT
Echocardiography
Undergo ECHO
Hematopoietic Cell Transplantation
Undergo HCT
Methotrexate
Given IV
Multigated Acquisition Scan
Undergo MUGA
Ruxolitinib Phosphate
Given PO
Tacrolimus
Given IV
Locations (1)
City of Hope Medical Center
Duarte, California, United States