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Janus Kinase (JAK) Inhibitor

Ruxolitinib for Polycythemia Vera

Phase 2
Recruiting
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up all patients who initiate treatment with study drug up to 60 months
Awards & highlights

Study Summary

This trial will assess the efficacy of ruxolitinib in reducing symptoms in patients with low-risk essential thrombocythemia (ET) or polycythemia vera (PV).

Who is the study for?
Adults diagnosed with low-risk essential thrombocythemia or polycythemia vera, without a history of high-risk factors like thrombosis or certain mutations. Participants must have specific blood count levels, organ function within normal ranges, and no severe cardiac issues. They should not be on conflicting medications, pregnant, breastfeeding, or at risk of pregnancy without contraception.Check my eligibility
What is being tested?
The trial is testing Ruxolitinib's effectiveness in reducing symptoms of essential thrombocythemia and polycythemia vera. It involves patients who meet specific criteria for these conditions and requires them to have a particular symptom score before starting the treatment.See study design
What are the potential side effects?
Ruxolitinib may cause side effects such as changes in blood counts leading to an increased risk of infections, liver problems indicated by abnormal lab values, potential harm to unborn babies (hence the need for contraception), and possibly other reactions similar to drugs with comparable chemical structures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all patients who initiate treatment with study drug up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and all patients who initiate treatment with study drug up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of patients who achieve >50% reduction from baseline to Myeloproliferative Neoplasm Symptom Assessment Total Symptom Score
Secondary outcome measures
Best MPN-SAF TSS score
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v 5.0
Percentage of change in Spleen Volume
+2 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
9%
Thrombocytosis
9%
Upper respiratory tract infection
9%
Hypercholesterolaemia
7%
Dyslipidaemia
7%
Pain in extremity
7%
Haematoma
7%
Abdominal discomfort
7%
Diarrhoea
7%
Dyspepsia
7%
Vomiting
7%
Blood lactate dehydrogenase increased
7%
Memory impairment
7%
Dyspnoea
5%
Tinnitus
5%
Osteoarthritis
5%
Leukocytosis
5%
Thrombocytopenia
5%
Flatulence
5%
Nausea
5%
Sinusitis
5%
Basal cell carcinoma
5%
Neuropathy peripheral
5%
Hyperuricaemia
3%
Cystitis
3%
Blood creatine phosphokinase increased
3%
Bronchitis
3%
Paraesthesia
3%
Skin ulcer
3%
Abdominal pain upper
3%
Pulmonary embolism
3%
Pneumonia
3%
Influenza
3%
Myalgia
3%
Urinary tract infection
3%
Depression
2%
Localised infection
2%
Intervertebral disc protrusion
2%
Urethral stenosis
2%
Night sweats
2%
Acute pulmonary oedema
2%
Vertigo
2%
Peripheral artery thrombosis
2%
Ureterolithiasis
2%
Pericardial effusion
2%
Acute myocardial infarction
2%
Syncope
2%
Gastrooesophageal reflux disease
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Cardiac disorder
2%
Mitral valve incompetence
2%
Vertigo positional
2%
Retinal artery occlusion
2%
Visual acuity reduced
2%
Gastrointestinal haemorrhage
2%
Oesophageal varices haemorrhage
2%
Lower respiratory tract infection
2%
Pyelonephritis
2%
Respiratory tract infection
2%
Sepsis
2%
Tendon rupture
2%
Ulna fracture
2%
Weight decreased
2%
Decreased appetite
2%
Hyponatraemia
2%
Blast cell crisis
2%
Bone marrow tumour cell infiltration
2%
Lung adenocarcinoma
2%
Metastases to spine
2%
Myelofibrosis
2%
Prostatic adenoma
2%
Squamous cell carcinoma of skin
2%
Nephrolithiasis
2%
Gamma-glutamyltransferase increased
2%
Haematocrit increased
2%
Musculoskeletal pain
2%
Ischaemic stroke
2%
Diabetes mellitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Crossover Patients
Best Available Therapy
Ruxolitinib

Trial Design

2Treatment groups
Experimental Treatment
Group I: Ruxolitinib Stage 2Experimental Treatment1 Intervention
Stage 2 will commence based on 3 or more participants in Stage 1 showing a predetermined positive response to Ruxolitinib. In stage 2, participants will be divided into two cohorts: Very low, Low, and Intermediate-risk ET patients with significant symptom burden and Low-risk PV patients with significant symptom burden Study cycles are 28 days long, participants in both cohorts will receive: Ruxolitinib 2x daily for 6 study cycles.
Group II: Ruxolitinib Stage 1Experimental Treatment1 Intervention
In stage 1, participants will be divided into two cohorts: Very low, Low, and Intermediate-risk ETpatients with significant symptom burden and Low-risk PV patients with significant symptom burden Study cycles are 28 days long, participants in both cohorts will receive: Ruxolitinib 2x daily for 6 study cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
FDA approved

Find a Location

Who is running the clinical trial?

Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,105 Total Patients Enrolled
17 Trials studying Polycythemia Vera
4,445 Patients Enrolled for Polycythemia Vera
Massachusetts General HospitalLead Sponsor
2,931 Previous Clinical Trials
13,198,385 Total Patients Enrolled
1 Trials studying Polycythemia Vera
10 Patients Enrolled for Polycythemia Vera
Gabriela Hobbs, MDPrincipal InvestigatorMassachusetts General Hospital
4 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Polycythemia Vera
10 Patients Enrolled for Polycythemia Vera

Frequently Asked Questions

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

Could you elucidate on the safety profile of Ruxolitinib for patients?

"Although ruxolitinib has limited evidence supporting its efficacy, the safety of this drug is still rated at a 2 on our scale due to some data that it is safe."

Answered by AI

What is the upper limit of participants for this research endeavor?

"Affirmative. According to information posted on clinicaltrials.gov, this study began recruiting participants since the 21st of March 2022 and is still seeking candidates as of October 2021. 60 volunteer test-subjects are required from 3 separate medical facilities."

Answered by AI

What medical purpose is Ruxolitinib typically employed for?

"Ruxolitinib is used to treat polycythemia vera and other related diseases, such as hydroxyurea-resistant or intolerant polycythemia and primary myelofibrosis."

Answered by AI

Are there any vacancies available to partake in this investigation?

"Affirmative. Clinicaltrials.gov records show that this clinical trial, launched on March 21st 2022, is actively enrolling patients for participation. Enrolment goals include 60 individuals distributed across 3 sites."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Beth-Israel Deaconess Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Ruxolitinib in Thrombocythemia and Polycythemia Vera
Gabriela Hobbs 2022. "Ruxolitinib in Thrombocythemia and Polycythemia Vera". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04644211.
All > Essential Thrombocythemia > Polycythemia Vera
~13 spots leftby Dec 2024
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