Actively Recruiting
Ruxolitinib Before, During and After Hematopoietic Cell Transplant in Older Patients With Myelofibrosis and Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes
Led by Fred Hutchinson Cancer Center · Updated on 2026-02-19
50
Participants Needed
1
Research Sites
238 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ruxolitinib Before, During and After Hematopoietic Cell Transplant in Older Patients With Myelofibrosis and Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years; patients over 75 must meet additional health criteria and be considered transplant candidates
- Diagnosis of primary or secondary myelofibrosis according to 2022 classification or MDS/MPN overlap syndrome
- Ability to understand and willingness to sign informed consent
- Potential candidate for hematopoietic cell transplant as assessed by physician
- Willingness to take a JAK inhibitor, preferably ruxolitinib, for at least 8 consecutive weeks before conditioning and continue as prescribed post-transplant
- Karnofsky performance status of at least 70; for patients over 75, at least 90
- Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score less than 8; less than 3 if over 75 years old
- Creatinine clearance greater than 60 ml/min
- Total serum bilirubin less than 3 mg/dL unless due to Gilbert's disease or hemolysis
- Transaminases less than three times the upper limit of normal
- No severe liver disease or conditions affecting liver function as specified
- Lung diffusion capacity for carbon monoxide corrected over 60% normal without oxygen support
- Left ventricular ejection fraction over 40%
- Donor must be HLA-matched sibling, 10/10 matched unrelated, or 9/10 mismatched unrelated donor
- Peripheral blood preferred over bone marrow for donation
- Donor selection preferences based on age and match as specified
You will not qualify if you...
- Known allergy or hypersensitivity to ruxolitinib, JAK inhibitors, or their ingredients
- Previous allogeneic stem cell transplant
- Leukemic transformation with more than 20% blasts
- Uncontrolled infections despite treatment
- History of HIV infection
- Untreated tuberculosis
- Pregnant or breastfeeding
- History of myocardial infarction, stroke, or unprovoked blood clots in the past 6 months
- Secondary cancers within the last 5 years with more than 20% risk of relapse
- Active or recent invasive fungal infection without infectious disease consultation and approval
- Requiring supplemental oxygen
- Severe liver disease such as fulminant liver failure, cirrhosis with portal hypertension, alcoholic hepatitis, or other specified liver conditions
- Patients without an appropriate HLA-matched donor as specified in the criteria
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
R
Rachel Salit, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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