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JAK Inhibitor

Peritransplant Ruxolitinib for Myelofibrosis

Phase 2
Recruiting
Led By Rachel B. Salit
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Potential hematopoietic stem cell transplant candidate
Meeting criteria for intermediate-1, intermediate-2 or high-risk disease by Dynamic International Prognostic Scoring System (DIPSS) or DIPSS plus
Must not have
Active uncontrolled infection
Uncontrolled viral or bacterial infection at the time of transplant data review and consent conference
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a drug can help prevent a condition where the transplanted cells from a donor can attack the body's normal cells and improve transplant outcomes in patients with primary and secondary myelofibrosis.

Who is the study for?
This trial is for adults over 18 with primary or secondary myelofibrosis, classified as intermediate-1, -2, or high-risk. Participants must have used ruxolitinib for at least 8 weeks before the transplant and be able to continue post-transplant. They should not have severe kidney or liver problems, uncontrolled infections, HIV, or be pregnant. A suitable stem cell donor is required.
What is being tested?
The study tests if ruxolitinib given before, during, and after a stem cell transplant can prevent graft versus host disease and improve outcomes in myelofibrosis patients. It involves chemotherapy drugs like Melphalan and Fludarabine followed by transplantation of donor stem cells.
What are the potential side effects?
Ruxolitinib may cause side effects such as anemia (low red blood cells), bruising/bleeding issues due to low platelets, dizziness/fainting from low blood pressure; other drugs involved also carry risks of infection risk increase and organ damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I might be a candidate for a bone marrow transplant.
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My condition is classified as intermediate-1, intermediate-2, or high-risk.
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I am able to care for myself but may not be able to do active work.
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I have been diagnosed with primary or secondary myelofibrosis.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an infection that is not under control.
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I do not have any uncontrolled infections.
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I have no known allergies or adverse reactions to ruxolitinib.
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I do not have severe kidney or liver problems.
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I have had a fungal infection without consulting an infectious disease specialist.
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My blood cancer has not transformed into a more aggressive form.
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I have a history of HIV infection.
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My platelet count is below 100, or I've had a transplant from another person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of grade II-IV graft versus host disease (GVHD) in myelofibrosis patients
Secondary study objectives
Incidence of grade III-IV GVHD
Incidence of primary and secondary graft failure
Non-relapse mortality (NRM)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (ruxolitinib, conditioning, HSCT, GVHD prophylaxis)Experimental Treatment15 Interventions
See detailed description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methotrexate
2019
Completed Phase 4
~4400
Computed Tomography
2017
Completed Phase 2
~2740
Cyclophosphamide
2010
Completed Phase 4
~2310
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1240
Total-Body Irradiation
1997
Completed Phase 3
~1180
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Busulfan
2008
Completed Phase 4
~1710
Ruxolitinib
2018
Completed Phase 3
~1170
Tacrolimus
2019
Completed Phase 4
~5510
Bone Marrow Aspiration and Biopsy
2016
Completed Phase 1
~40
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Ultrasound Imaging
2018
Completed Phase 4
~760
Echocardiography
2013
Completed Phase 4
~11580
Melphalan
2008
Completed Phase 3
~1500
Fludarabine
2012
Completed Phase 4
~1860

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
147,949 Total Patients Enrolled
13 Trials studying Primary Myelofibrosis
713 Patients Enrolled for Primary Myelofibrosis
Fred Hutchinson Cancer CenterLead Sponsor
569 Previous Clinical Trials
1,340,176 Total Patients Enrolled
14 Trials studying Primary Myelofibrosis
743 Patients Enrolled for Primary Myelofibrosis
Rachel B. SalitPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
3 Previous Clinical Trials
127 Total Patients Enrolled
2 Trials studying Primary Myelofibrosis
81 Patients Enrolled for Primary Myelofibrosis

Media Library

Ruxolitinib (JAK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04384692 — Phase 2
Primary Myelofibrosis Research Study Groups: Treatment (ruxolitinib, conditioning, HSCT, GVHD prophylaxis)
Primary Myelofibrosis Clinical Trial 2023: Ruxolitinib Highlights & Side Effects. Trial Name: NCT04384692 — Phase 2
Ruxolitinib (JAK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04384692 — Phase 2
~10 spots leftby Dec 2025
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