Suspended

Ruxolitinib Treatment for Primary and Secondary Myelofibrosis Before and After Stem Cell Transplant

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Study Aim

This phase 2 study aims to evaluate the impact of Ruxolitinib treatment on reducing the incidence of severe graft versus host disease in patients with primary and secondary myelofibrosis, before and after stem cell transplant.

What is being tested

Allogeneic Hematopoietic Stem Cell Transplantation

+ Busulfan

+ Cyclophosphamide

ProcedureDrugRadiation
Who is being recruted

Bone Marrow Diseases+2

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

Over 18 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 2020
See protocol details

Summary

Principal SponsorFred Hutchinson Cancer Center
Last updated: January 31, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 18, 2020

Actual date on which the first participant was enrolled.

This clinical trial aims to explore the effectiveness of a drug called ruxolitinib for patients diagnosed with primary and secondary myelofibrosis, a condition where the bone marrow is replaced by scar tissue. The study focuses on patients who are set to undergo a hematopoietic stem cell transplantation, a procedure that can help restore the body's ability to produce healthy blood cells. The importance of this study lies in its potential to improve the transplantation process and reduce the risk of complications, ultimately enhancing the quality of care for individuals living with myelofibrosis. Participants in this study will receive ruxolitinib orally starting 8 weeks before the transplantation and continuing until approximately 14 days prior to the conditioning regimen. After the transplant, they will receive ruxolitinib again until around 7 months post-transplant, followed by a gradual reduction over 2 months. The study also involves different conditioning regimens depending on the patient's specific needs, and various tests like CT scans, blood sample collections, and bone marrow biopsies to monitor the progress. The primary outcome measured is the incidence of a complication called graft versus host disease (GVHD), which will be compared to a fixed benchmark from a previous study.

Official TitlePeritransplant Ruxolitinib for Patients With Primary and Secondary Myelofibrosis
NCT04384692
Principal SponsorFred Hutchinson Cancer Center
Last updated: January 31, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

79 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesMyeloproliferative DisordersPrimary Myelofibrosis

Criteria

15 inclusion criteria required to participate
Performance status score: Karnofsky >= 70

Disease criteria: Diagnosis of primary myelofibrosis (PMF) as defined by the 2016 World Health Organization classification system or diagnosis of secondary myelofibrosis (MF) as defined by the International Working Group (IWG) for Myeloproliferative Neoplasms Research and Treatment criteria

Patient must be willing to start ruxolitinib within a 6-month time period

Patients meeting the criteria for intermediate-1, intermediate-2 or high-risk disease by Dynamic International Prognostic Scoring System (DIPSS) or DIPSS plus

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9 exclusion criteria prevent from participating
History of HIV infection

History of prior allogeneic transplant

Contraindication to receiving ruxolitinib 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

Leukemic transformation (> 20% blasts)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
See detailed description.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Fred Hutch/University of Washington Cancer Consortium

Seattle, United StatesOpen Fred Hutch/University of Washington Cancer Consortium in Google Maps
SuspendedOne Study Center