RecruitingPhase 2NCT07228624

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

Peri-Hematopoietic Cell Transplantation Ruxolitinib in Patients With Myelofibrosis and Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes


Sponsor

Fred Hutchinson Cancer Center

Enrollment

50 participants

Start Date

Feb 4, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Allogeneic Hematopoietic Stem Cell Transplantation, a procedure called Biospecimen Collection, and others for people with myelodysplastic/myeloproliferative neoplasm, primary myelofibrosis, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRuxolitinib

Given PO

PROCEDUREAllogeneic Hematopoietic Stem Cell Transplantation

Given infusion

DRUGBusulfan

Given IV

PROCEDUREComputed Tomography

Undergo CT

DRUGCyclophosphamide

Given IV

PROCEDUREEchocardiography Test

Undergo echocardiography

DRUGFludarabine

Given IV

DRUGJAK Inhibitor

Given JAK inhibitor

DRUGMelphalan

Given IV

DRUGMethotrexate

Given IV

DRUGTacrolimus

Given IV or PO

PROCEDUREBiospecimen Collection

Undergo urine and blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy and aspiration


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

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NCT07228624


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