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Ruxolitinib Before, During and After Hematopoietic Cell Transplant in Older Patients With Myelofibrosis and Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes

StatusRecruiting
PhasePhase 2
Started2026-02-04
View on ClinicalTrials.gov ↗

Amendment history

2026-08-17
minor
Study Status v5
Re-verified, no change to tracked fields
2026-02-17
minor
Study Identification, Study Status v4
Start date2026-02-10→2026-02-04
2026-02-12
minor
Study Status v3
Start dateestimated 2026-02-21→confirmed 2026-02-10
2026-01-21
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2026-05-01→2026-02-21
Study sitesdetails revised at 1 of 1 site
2026-01-14
minor
Study Status v1
Re-verified, no change to tracked fields
2025-11-13
minor
Original filing
This phase II trial tests the effect of adding ruxolitinib to standard graft versus host disease (GVHD) prevention in treating older patients with myelofibrosis (MF) or myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) overlap syndromes before, during, and after a donor (allogeneic) hematopoietic cell transplant (HCT). Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical donor. Giving chemotherapy, such as cytoxan and busulfan or fludarabine and melphalan, before a donor transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. However, sometimes the transplanted cells from a donor can attack the body's normal cells (called GVHD). Giving standard prevention (prophylaxis) therapies, such as tacrolimus and methotrexate, after the transplant may stop this from happening. Methotrexate, a type of antifolate, is in a class of medications called antimetabolites. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid and may kill cancer cells. Tacrolimus is used to help reduce the risk of rejection by the body of organ and bone marrow transplants. Ruxolitinib, a type of Janus-associated kinase (JAK) inhibitor, blocks a protein called JAK, which may help keep abnormal blood cells or cancer cells from growing. It may also lower the body's immune response and prevent the development of GVHD. Giving ruxolitinib before, during and after allogeneic HCT in addition to standard GVHD prophylaxis may be safe, tolerable and effective in preventing GVHD and improving outcomes in older patients with MF or MDS/MPN overlap syndrome.
Trial Details
NCT Number NCT07228624
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: Incyte Corporation
Conditions Myelodysplastic/Myeloproliferative Neoplasm, Primary Myelofibrosis, Secondary Myelofibrosis
Enrollment 50 participants
Start Date 2026-02-04
Primary Completion 2030-09-01 (estimated)
Study Completion 2030-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-19