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Reduced Intensity Haploidentical Transplantation for Myelofibrosis

This study is looking at a treatment approach for primary or secondary myelofibrosis (a bone marrow disorder). It combines a JAK inhibitor (a type of drug) with a reduced intensity haploidentical transplant. A haploidentical transplant uses stem cells from a donor who is only a partial match, often a family member. The study uses several medications including Cyclophosphamide, Fludarabine, Melphalan, and Recombinant Granulocyte Colony-Stimulating Factor. Researchers want to see how well this treatment prevents graft failure (when the body rejects the new stem cells) over up to 5 years. You might be able to join if you are between 18 and 70 years old and have primary or secondary myelofibrosis. The study is currently unclear on its recruitment status, with a planned enrollment of 20 participants.

Study design
This is an interventional study with a planned enrollment of 20 participants. It is not specified if it is randomized or blinded.
What's involved
Participants receive a JAK inhibitor before and after transplant. They will also receive several intravenous (IV) and subcutaneous (SC) medications around the time of transplant.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to measure the probability of graft failure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04370301

Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary Myelofibrosis

Recruiting
PHASE2Ages 18–70InterventionalTreatment
Fred Hutchinson Cancer Center
~20 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:CyclophosphamideJAK InhibitorFludarabineRecombinant Granulocyte Colony-Stimulating FactorMelphalanMycophenolate Mofetil

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Probability of primary and secondary graft failure
Measured over Up to 5 years

Conditions

Primary Myelofibrosis
Secondary Myelofibrosis

Explore related trials

Primary MyelofibrosisSecondary Myelofibrosis

NCT04370301

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washingtonstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Rachel B. Salit · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Rachel B. Salit
[email protected]
206-667-1317
Email the study team

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Eligibility criteria

Inclusion

Age between 18 and 70 years
Diagnosis of primary myelofibrosis (PMF) as defined by the 2016 World Health Organization classification system or diagnosis of secondary MF as defined by the International Working Group (IWG) for Myeloproliferative Neoplasms Research and Treatment criteria
Patients meeting the criteria for intermediate-1, intermediate-2 or high-risk disease by the Dynamic International Prognostic Scoring System (DIPSS)-plus scoring system (DIPSS may be used if all data from DIPSS are not available)
Ability to understand and the willingness to sign a written informed consent document (or legally authorized representative)
Patient must be a potential hematopoietic stem cell transplant candidate
Meeting criteria for 1st phase as above, at time of initiation of JAK inhibitor, including ability to understand and willingness to sign a written informed consent (or legally authorized representative). Patients arriving to our institution for transplant and not enrolled in Part 1 may still be enrolled in Part 2 if Part 1 criteria met. These patients will have Part 1 endpoints transcribed from medical records
Received JAK inhibitor for at least 8 weeks immediately prior to conditioning and be willing to continue until 9-12 months post-transplant as tolerated
Karnofsky performance status score \>= 70
Calculated creatinine clearance using the Cockcroft-Gault formula or 24 hour (hr) urine creatinine clearance must be \> 60 ml/min
Total serum bilirubin must be \< 3 mg/dL unless the elevation is thought to be due to Gilbert's disease or hemolysis
Transaminases must be \< 3 x the upper limit of normal
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 \> 3 mg/dL, and symptomatic biliary disease will be excluded
Diffusion capacity of the lung for carbon monoxide (DLCO) corrected \> 60% normal; may not be on supplemental oxygen
Left ventricular ejection fraction \> 40% OR shortening fraction \> 26%
Comorbidity Index \< 5 at the time of pre-transplant evaluation
DONOR: Patients must be screened prior to transplant for donor-specific anti-HLA antibodies (DSA). Patients with DSA will be reviewed by the principal investigator and considered for desensitization treatment
DONOR: Children are preferred over siblings and parents
DONOR: Younger donors are preferred over older donors
DONOR: ABO matched donors are preferred over minor ABO mismatched and over major ABO mismatch donors

Exclusion

Contraindication to receiving a JAK inhibitor including:
Patients who have known hypersensitivity to JAK inhibitors
Clinical or laboratory evidence of significant renal or hepatic impairment including cirrhosis
Active uncontrolled infection
Known human immunodeficiency virus (HIV) positivity
Women who are pregnant or trying to conceive
Caution should be used in patients with platelets \< 100 though adjustments in dose can be made to accommodate anyone with platelets \> 50
History of prior allogeneic transplant
Leukemic transformation (\> 20% blasts)
Uncontrolled viral or bacterial infection at the time of study enrollment
Active or recent (prior 6 month) invasive fungal infection without infectious disease (ID) consult and approval
Known HIV positivity
Pregnant or breastfeeding
Availability of an human leukocyte antigen (HLA)-identical or 1-allele-mismatched related donor or an HLA 10 of 10 matched unrelated donor

What this trial measures

  • Probability of primary and secondary graft failureUp to 5 years

    Primary graft failure is defined as failure to achieve an absolute neutrophil count of \> 500/ul by 42 days after bone marrow or peripheral blood stem cell transplantation. Secondary graft failure is defined as cytopenias after initial engraftment, with (a) donor chimerism of \< 5% or (b) falling donor chimerism with intervention such as second transplant or donor lymphocyte infusion or (c) patient death due to cytopenias, and fall in donor chimerism, even if chimerism is \> 5%. Exclusion criteria for diagnosis of graft failure are (a) disease relapse, (b) graft-versus-host disease, and (c) other causes of cytopenias such as, viral infection and drug toxicity.