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Ruxolitinib Based GVHD Prophylaxis Regimen Before, During, and After Hematopoietic Cell Transplantation in Older Adult Patients With Acquired Aplastic Anemia
Sponsor: Fred Hutchinson Cancer Center
Summary
This phase II trial tests how well a ruxolitinib-based graft versus host disease (GVHD) prevention (prophylaxis) regimen works before, during, and after bone marrow/stem cell transplantation (hematopoietic cell transplantation \[HCT\]) in patients with acquired aplastic anemia. Acquired aplastic anemia (AA) is a condition in which the bone marrow is unable to produce blood cells. Affected patients typically present with infections due to abnormally low number of neutrophils, bleeding due to low platelet count, and/or fatigue due to a lower-than-normal number of red blood cells (anemia). Its incidence varies with age, occurring most frequently in patients aged 2-5 years, 20-25 years, and 55 years and older. Treatment of AA includes either immunosuppressive therapy (IST) or bone marrow/stem cell transplantation (HCT) with first-line therapy in younger adults often being HCT, while adults over 40 still frequently trial IST first due to the morbidity and mortality concerns with HCT. GVHD is a common complication after donor stem cell transplantation, resulting from donor immune cells recognizing recipients' cells and attacking them. Ruxolitinib, a drug in a class of oral medications called JAK inhibitors has been approved for the treatment of acute and chronic GVHD. It has also been shown to decrease GVHD when used in the prevention setting in patients with myelofibrosis. The current study aims to assess whether adding ruxolitinib to a standard GVHD prevention regimen may reduce the risk of Grade II-IV acute and chronic GVHD after bone marrow/stem cell transplantation in older patients with acquired aplastic anemia.
Official title: Ruxolitinib Based GVHD Prophylaxis Regimen for Older Adults Receiving Non-ATG Containing Non-Myeloablative Hematopoietic Cell Transplantation for Acquired Aplastic Anemia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-09-25
Completion Date
2027-12-31
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
Biospecimen Collection
Undergo blood sample collection
Bone Marrow Aspiration
Undergo bone marrow biopsy and aspiration
Bone Marrow Biopsy
Undergo bone marrow biopsy and aspiration
Bone Marrow Transplantation
Undergo bone marrow transplant
Computed Tomography
Undergo CT
Cyclosporine
Given PO
Fludarabine
Given IV
Granulocyte Colony-Stimulating Factor
Given SC
Mycophenolate Mofetil
Given PO
Peripheral Blood Stem Cell Transplantation
Undergo PBSC transplantation
Ruxolitinib
Given PO
Sirolimus
Given PO
Total-Body Irradiation
Undergo TBI
Multigated Acquisition Scan
Undergo MUGA
Echocardiography
Undergo ECHO
Locations (1)
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States