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Janus Kinase (JAK) Inhibitor

Ruxolitinib for Myelofibrosis

Phase 2

Waitlist Available

Led By Gabriela Hobbs, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Off all MF-directed therapy at the time of enrollment, with the exception of ruxolitinib

ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 and 2 years

Awards & highlights

Study Summary

This trial is testing Ruxolitinib as a possible treatment for Myelofibrosis, a disorder where the bone marrow doesn't make enough blood cells.

Who is the study for?

This trial is for adults aged 18-75 with primary or secondary myelofibrosis, who are either already taking Ruxolitinib or will start it. They must have symptoms like an enlarged spleen and meet certain blood count criteria. Participants should be fit enough for a stem cell transplant from a matched donor and not have severe organ damage, uncontrolled infections, heart failure, other recent cancers (except some skin cancers), or be pregnant.Check my eligibility

What is being tested?

The study tests the drug Ruxolitinib in patients with myelofibrosis before, during, and after they receive a hematopoietic stem cell transplant (HSCT). The goal is to see how well Ruxolitinib works as part of the treatment process for this condition.See study design

What are the potential side effects?

Ruxolitinib may cause side effects such as low blood counts leading to increased infection risk, bleeding problems, dizziness or headaches. It can also affect liver enzymes which might indicate liver issues. Some people might experience weight gain or swelling around their body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am not on any treatment for myelofibrosis except ruxolitinib.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

I am scheduled for a stem cell transplant using donor cells.

Select...

My condition is officially diagnosed as primary or secondary myelofibrosis.

Select...

My donor for the transplant matches me closely in important genetic markers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 and 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 and 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

GVHD free and relapse free survival at 1 year

Secondary outcome measures

Cumulative incidence of aGVHD

Cumulative incidence of cGVHD

Hemopoietic stem cell transplant

+4 more

Side effects data

From 2020 Phase 3 trial • 149 Patients • NCT02038036

33%

Anaemia

19%

Hypertension

17%

Nasopharyngitis

16%

Weight increased

14%

Herpes zoster

14%

Constipation

14%

Abdominal pain

14%

Headache

12%

Pruritus

12%

Back pain

12%

Epistaxis

12%

Pyrexia

12%

Dizziness

10%

Asthenia

10%

Fatigue

10%

Cough

10%

Oedema peripheral

10%

Arthralgia

Thrombocytosis

Upper respiratory tract infection

Hypercholesterolaemia

Dyslipidaemia

Pain in extremity

Haematoma

Abdominal discomfort

Diarrhoea

Dyspepsia

Vomiting

Blood lactate dehydrogenase increased

Memory impairment

Dyspnoea

Tinnitus

Osteoarthritis

Leukocytosis

Thrombocytopenia

Flatulence

Nausea

Sinusitis

Basal cell carcinoma

Neuropathy peripheral

Hyperuricaemia

Paraesthesia

Cystitis

Bronchitis

Blood creatine phosphokinase increased

Skin ulcer

Abdominal pain upper

Pulmonary embolism

Pneumonia

Influenza

Myalgia

Urinary tract infection

Depression

Localised infection

Intervertebral disc protrusion

Urethral stenosis

Night sweats

Acute pulmonary oedema

Vertigo

Peripheral artery thrombosis

Ureterolithiasis

Pericardial effusion

Acute myocardial infarction

Syncope

Gastrooesophageal reflux disease

General physical health deterioration

Atrial fibrillation

Cardiac disorder

Mitral valve incompetence

Vertigo positional

Retinal artery occlusion

Visual acuity reduced

Gastrointestinal haemorrhage

Oesophageal varices haemorrhage

Lower respiratory tract infection

Pyelonephritis

Respiratory tract infection

Sepsis

Tendon rupture

Ulna fracture

Weight decreased

Decreased appetite

Hyponatraemia

Blast cell crisis

Bone marrow tumour cell infiltration

Lung adenocarcinoma

Metastases to spine

Myelofibrosis

Prostatic adenoma

Squamous cell carcinoma of skin

Nephrolithiasis

Gamma-glutamyltransferase increased

Haematocrit increased

Musculoskeletal pain

Ischaemic stroke

Diabetes mellitus

100%

80%

60%

40%

20%

Study treatment Arm

All Crossover Patients

Best Available Therapy

Ruxolitinib

Trial Design

2Treatment groups

Experimental Treatment

Group I: Ruxolitinib Not Eligible pre-HSCTExperimental Treatment1 Intervention

Ruxolitinib will be taken orally at a fixed dose twice every day after transplant Dosing will be continuous, with a new cycle scheduled to start every 28 days. There will be no break in dosing between cycles Ruxolitinib can be administered with or without food.

Group II: Ruxolitinib Eligible pre-HSCTExperimental Treatment1 Intervention

Ruxolitinib will be taken orally at a fixed dose twice every day Dosing will be continuous, with a new cycle scheduled to start every 28 days. There will be no break in dosing between cycles Ruxolitinib can be administered with or without food.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib

FDA approved

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Incyte CorporationIndustry Sponsor

367 Previous Clinical Trials

55,384 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,937 Previous Clinical Trials

13,199,006 Total Patients Enrolled

Gabriela Hobbs, MD4.04 ReviewsPrincipal Investigator - Massachusetts General Hospital

Massachusetts General Hospital

4 Previous Clinical Trials

116 Total Patients Enrolled

5Patient Review

I was always made to feel cared for, never rushed, and given as much time as I needed during appointments. Dr. Smith is also very knowledgeable and quick to return calls. I am very impressed with her as both a physician and a human being.

Media Library

Ruxolitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03427866 — Phase 2

Myelofibrosis Research Study Groups: Ruxolitinib Not Eligible pre-HSCT, Ruxolitinib Eligible pre-HSCT

Myelofibrosis Clinical Trial 2023: Ruxolitinib Highlights & Side Effects. Trial Name: NCT03427866 — Phase 2

Ruxolitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03427866 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are total are enrolled in this clinical trial?

"Yes, this is an ongoing clinical trial that was originally posted on 8/28/2018. The latest update to the study's information was made on 10/21/2022. At present, 54 patients are being recruited from 5 different medical facilities."

Answered by AI

Are patients currently being accepted for this clinical trial?

"The trial is currently ongoing, as seen on clinicaltrials.gov. Recruitment for the study began on 8/28/2018 and the most recent update was on 10/21/2022."

Answered by AI

Does this study have any age requirements?

"For this particular clinical trial, patients between 18-75 years old are eligible to enroll. By comparison, there are 34 trials for patients younger than 18 and 195 trials for patients older than 65."

Answered by AI

What type of patient would not be able to receive Ruxolitinib prior to a HSCT procedure?

"Ruxolitinib Not Eligible pre-HSCT is effective in treating polycythemia vera. This drug can also help patients with conditions like hydroxyurea resistance or intolerance, and primary myelofibrosis."

Answered by AI

To whom is this clinical trial available?

"The ideal candidate for this clinical trial would be somebody suffering from primary myelofibrosis between the ages of 18 and 75. So far, 54 people have met the qualifications and enrolled in the study."

Answered by AI

Would you be able to share how many hospitals are a part of this research?

"There are 4 primary centres for this trial. They are Vanderbilt University, Washington University, The Ohio State University Wexner Medical Center, and 5 other locations."

Answered by AI

How does Ruxolitinib Not Eligible pre-HSCT affect patients?

"While there is some evidence supporting the safety of Ruxolitinib, it did not yet receive a score of 3 because Phase 2 trials have limited data on efficacy."

Answered by AI

Are there other cases where Ruxolitinib wasn't effective in treating patients before a stem cell transplant?

"Ruxolitinib was first studied in 2002 at the National Institutes of Health Clinical Center. As of now, there are 92 completed trials and 99 live clinical trials studying this medication. A large portion of these studies are based in Nashville, Tennessee."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ruxolitinib Pre-, During- and Post-HSCT for Patients With Primary or Secondary Myelofibrosis.

Gabriela Hobbs 2018. "Ruxolitinib Pre-, During- and Post-HSCT for Patients With Primary or Secondary Myelofibrosis.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03427866.

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