Actively Recruiting
Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary Myelofibrosis
Led by Fred Hutchinson Cancer Center · Updated on 2026-01-12
20
Participants Needed
1
Research Sites
446 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This initial cohort of this phase II trial studied the outcomes of using a JAK inhibitor prior to reduced intensity haploidentical (Haplo) transplantation for the treatment of primary or secondary myelofibrosis (MF). The primary risk of using Haplo HCT in patients with MF is graft failure. In the first cohort, all patients engrafted. There were no instances of graft failure. However, a large number of patients did have graft versus host disease as a complication of their transplant. JAK inhibitors have since been approved for the indication of graft versus host disease treatment. And we are also using them for graft versus host disease prevention in a study of MF patients with sibling and unrelated donors. Therefore, we are opening a new cohort of the current study using the JAK inhibitor prior to, during and after Haplo transplant. Our goal is to decrease graft versus host disease in patients receiving a Haplo MF transplant without increasing the risk of graft failure.
CONDITIONS
Official Title
Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary Myelofibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Diagnosis of primary myelofibrosis or secondary myelofibrosis as defined by established criteria
- Intermediate-1, intermediate-2, or high-risk disease by DIPSS-plus or DIPSS scoring system
- Ability and willingness to sign informed consent
- Potential candidate for hematopoietic stem cell transplant
- Received JAK inhibitor for at least 8 weeks before conditioning and willing to continue up to 9-12 months post-transplant
- Karnofsky performance status score of 70 or higher
- 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 3 times the upper limit of normal
- Lung diffusion capacity (DLCO) corrected greater than 60% and not on supplemental oxygen
- Left ventricular ejection fraction greater than 40% or shortening fraction greater than 26%
- Comorbidity index less than 5 at pre-transplant evaluation
- Patients must be screened for donor-specific anti-HLA antibodies prior to transplant
- Donors preferred to be children over siblings and parents, younger donors over older donors, and ABO matched over mismatched donors
You will not qualify if you...
- Known hypersensitivity to JAK inhibitors
- Significant renal or hepatic impairment including cirrhosis
- Active uncontrolled infection
- Known HIV positivity
- Pregnant or breastfeeding women
- Platelet count below 50 (caution for counts below 100)
- History of prior allogeneic transplant
- Leukemic transformation with more than 20% blasts
- Uncontrolled viral or bacterial infection at enrollment
- Active or recent invasive fungal infection without infectious disease consult and approval
- Availability of an HLA-identical or 1-allele-mismatched related donor or an HLA 10 of 10 matched unrelated donor
AI-Screening
AI-Powered 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 B. Salit
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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