Ruxolitinib with Transplant for Myelofibrosis and MDS/MPN Overlap Syndromes
This study is testing if adding ruxolitinib (a medication) to standard care helps older patients with myelofibrosis or myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) overlap syndromes when they receive a stem cell transplant (HCT). An HCT is a procedure where you get healthy blood-forming cells from a donor. Ruxolitinib is given before, during, and after the transplant. The study wants to see how many patients develop graft-versus-host disease (GVHD), a common complication after transplant, within the first 100 days. You might be able to join if you are between 18 and 75 years old, or older than 75 with certain health conditions. The study plans to enroll 50 people, but its current status is unclear.
- Study design
- This is an interventional study with an estimated enrollment of 50 participants. It is testing ruxolitinib alongside standard transplant procedures.
- What's involved
- You would receive ruxolitinib for at least 8 weeks before transplant and for 18 months after. You would also undergo procedures like CT scans, blood draws, and bone marrow biopsies at various times.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, you would have follow-up visits at specific times for up to 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07228624
Ruxolitinib Before, During and After Hematopoietic Cell Transplant in Older Patients With Myelofibrosis and Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes
Recruiting
PHASE2Ages 18–75InterventionalTreatmentFred Hutchinson Cancer CenterInvestigator-initiated
~50 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:RuxolitinibAllogeneic Hematopoietic Stem Cell TransplantationBusulfanComputed TomographyCyclophosphamideEchocardiography Test
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of grade II-IV graft versus host disease (GVHD) requiring systemic immune suppression
Measured over Up to day-100
Conditions
Where it's being run
1 sites across 1 statesWashington1
Study leadership
- Rachel Salit, MD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
PART 1 JAK INHIBITOR ADMINISTRATION: Age 18-75 years
Patients \> 75 must be considered an HCT candidate, meet all protocol criteria and have comorbidity score =\< 3 and Karnofsky performance status (KPS) \> or = to 90. Patients. \> 75 who do not meet these criteria may be presented at PCC for consensus exception
PART 1 JAK INHIBITOR ADMINISTRATION: Disease criteria
Diagnosis of primary or secondary MF as defined by the 2022 World Health Organization classification system or the International Consensus Classification for Myeloid and Acute Leukemias
Diagnosis of an MDS/MPN overlap syndrome as defined by the 2022 World Health Organization
PART 1 JAK INHIBITOR ADMINISTRATION: Ability to understand and the willingness to sign a written informed consent document
PART 1 JAK INHIBITOR ADMINISTRATION: Patient must be a potential HCT candidate as assessed by the consenting physician
PART 1 JAK INHIBITOR ADMINISTRATION: Patient must be agreeable to taking a JAK-inhibitor (ruxolitinib preferred) for at least 8 consecutive weeks immediately prior to conditioning and be willing to take ruxolitinib 5mg BID starting from day -4 prior to and continuing until 12 months post-transplant as tolerated followed by a 6-month taper.
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Meeting criteria for Part 1 at time of initiation of JAK-inhibitor, including the ability to understand and willingness to sign a written informed consent. Patients arriving to our institution for HCT and not enrolled in Part 1 may still be enrolled in Part 2 if Part 1 criteria are met. These patients will have Part 1 endpoints transcribed from their medical records
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Received a JAK-inhibitor for at least 8 weeks immediately prior to conditioning and be willing to take Rux from day -4 at the 5mg BID dose until 12 months post-transplant as tolerated followed by a 6 month taper
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Performance status score
Karnofsky ≥ 70 or \> 90 for patients \> 75 years old
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: HCT-CI Score \< 8; if patient is \> 75 years old HCT-CI \< 3
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Calculated creatinine clearance using the Cockcroft-Gault formula or 24-hour urine creatinine clearance must be \> 60 ml/min
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Total serum bilirubin must be \< 3mg/dL unless the elevation is thought to be due to Gilbert's disease or hemolysis
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Transaminases must be \< 3 x the upper limit of normal
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function, and the degree of portal hypertension. Patients with fulminant liver failure, cirrhosis with evidence of portal hypertension or bridging fibrosis, alcoholic hepatitis, hepatic encephalopathy, or correctable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin \> 3mg/dL, and symptomatic biliary disease will be excluded
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Diffusion capacity of lung for carbon monoxide (DLCO) corrected \> 60% normal. Patient may not be on oxygen
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Left ventricular ejection fraction \> 40%
DONOR: Human leukocyte antigen (HLA)-matched sibling donor
DONOR: 10 of 10 HLA-matched unrelated donor
DONOR: 9 of 10 allele or antigen mismatched unrelated donor
DONOR: Peripheral blood is preferred over bone marrow
DONOR: Matched unrelated donors may be preferred over siblings if the unrelated donor is \< 30 years and the sibling is \> 60 years. However, sibling donors \< 70 should be preferred over mismatched unrelated donors
Exclusion
PART 1 JAK INHIBITOR ADMINISTRATION: Contraindication to receiving ruxolitinib including patients who have known hypersensitivity to JAK inhibitors and excipients
PART 1 JAK INHIBITOR ADMINISTRATION: History of prior allogeneic transplant
PART 1 JAK INHIBITOR ADMINISTRATION: Leukemic transformation (\> 20% blasts)
PART 1 JAK INHIBITOR ADMINISTRATION: Uncontrolled viral, bacterial, or fungal infection despite being on therapy
PART 1 JAK INHIBITOR ADMINISTRATION: History of HIV infection
PART 1 JAK INHIBITOR ADMINISTRATION: History of untreated tuberculosis (TB)
PART 1 JAK INHIBITOR ADMINISTRATION: Pregnant or breastfeeding
PART 1 JAK INHIBITOR ADMINISTRATION: Patients with history of myocardial infarction (MI), cerebrovascular accident (CVA) or unprovoked pulmonary embolism (PE)/deep vein thrombosis (DVT) in the past 6 months
PART 1 JAK INHIBITOR ADMINISTRATION: Secondary malignancy in last 5 years with \> 20% risk of relapse
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Contraindication to receiving ruxolitinib including patients who have known hypersensitivity to JAK inhibitors and excipients
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: History of prior allogeneic transplant
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Leukemic transformation (\> 20% blasts)
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Uncontrolled viral or bacterial infection at the time of transplant data review and consent conference
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Active or recent (prior 6 month) invasive fungal infection without infectious disease (ID) consult and approval
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: History of HIV infection
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: History of untreated TB
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Requiring supplemental oxygen
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Pregnant or breastfeeding
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Secondary malignancy in last 5 years with \> 20% risk of relapse
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Patients with a history of MI, CVA, or unprovoked PE/DVT in the past 6 months
PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Patients without an HLA-identical sibling donor, 10 of 10 HLA-matched or 9 of 10 mismatched unrelated donor
What this trial measures
- Incidence of grade II-IV graft versus host disease (GVHD) requiring systemic immune suppressionUp to day-100
Will be estimated as a simple proportion, and the upper bound of the one-sided 95% confidence interval for the estimated proportion will be estimated using the Clopper-Pearson method. The exact binomial test will be used to compare the observed probability to the benchmark of 65%.