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Janus Kinase (JAK) Inhibitor

Ruxolitinib for Graft-versus-Host Disease

Phase 2
Waitlist Available
Led By Vijaya Bhatt, MD
Research Sponsored by University of Nebraska
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 6 months
Awards & highlights

Study Summary

This trial is testing if a drug called ruxolitinib can help people with a condition called sclerotic chronic GVHD.

Eligible Conditions
  • Graft-versus-Host Disease

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Complete and Partial Responses in Skin and/or Joint
Secondary outcome measures
Percentage of Participants With Complete or Partial Responses Overall

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

1Treatment groups
Experimental Treatment
Group I: RuxolitinibExperimental Treatment1 Intervention
Patients will receive oral ruxolitinib at a dose of 10 mg twice daily.
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?

University of NebraskaLead Sponsor
539 Previous Clinical Trials
1,144,685 Total Patients Enrolled
Vijaya Bhatt, MDPrincipal InvestigatorUniversity of Nebraska
1 Previous Clinical Trials
45 Total Patients Enrolled
Vijaya Bhatt, M.D.Principal InvestigatorUniversity of Nebraska

Frequently Asked Questions

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

What is the upper limit of participant enrollment for this clinical experimentation?

"Unfortunately, this trial is currently not enrolling patients. Initially posted on September 5th 2018 and subsequently updated August 4th 2022, individuals seeking clinical trials can use the search function to discover 169 studies for graft vs host disease or 97 investigations involving Ruxolitinib that are recruiting participants."

Answered by AI

Is enrollment for this research study still open?

"Unfortunately, this research is no longer accepting interviewees. It was first listed on September 5th 2018 and has since been revised on August 4th 2022. Fortunately, there are an abundance of studies still looking for Graft vs Host Disease patients (169 trials) as well as Ruxolitinib trial participants (97 investigations)."

Answered by AI

How many locations in Canada are hosting this research endeavor?

"At present, there are 5 sites hosting this clinical trial: Columbus, Tampa and Cleveland can be found alongside 2 other locales. It is recommended to choose the most convenient site of these five in order to reduce any travel costs that may arise from participation."

Answered by AI

Could you elucidate the hazards of Ruxolitinib for human health?

"Given the Phase 2 status of Ruxolitinib, there is some evidence that suggests it can be reasonably safe; thus it received an assessed safety rating of 2."

Answered by AI

To what illnesses is Ruxolitinib generally administered?

"Ruxolitinib is widely prescribed for polycythemia vera and has also been demonstrated to be effective at treating cases of hydroxyurea-resistant or -intolerant polycythemia, as well as primary myelofibrosis."

Answered by AI

Are there prior investigations that utilized Ruxolitinib?

"Since 2002, the National Institutes of Health's Clinical Center has been researching ruxolitinib. As of now, there are 93 terminated clinical trials and 97 active medical studies that largely take place in Columbus, Ohio."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Ruxolitinib in Sclerotic Chronic Graft-Versus-Host Disease After Failure of Systemic Glucocorticoids
Vijaya Bhatt 2018. "Study of Ruxolitinib in Sclerotic Chronic Graft-Versus-Host Disease After Failure of Systemic Glucocorticoids". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03616184.
~7 spots leftby Apr 2025
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