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Corticosteroid

Ruxolitinib vs Prednisone for Graft-versus-Host Disease

Phase 2
Waitlist Available
Led By Farhad Khimani, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Karnofsky performance status ≥60%
Must not have
Active hepatitis B, hepatitis C, and HIV
Pregnant women and lactating women
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to compare Ruxolitinib to prednisone as a first-line therapy for chronic GVHD, a complication that can occur after a transplant for certain blood cancers. Ruxol

Who is the study for?
This trial is for individuals with chronic graft-versus-host disease (GVHD) after an allogeneic transplant. Participants should need systemic therapy but haven't yet been treated, or their condition didn't improve with initial treatments.
What is being tested?
The study compares Ruxolitinib to Prednisone as a first-line treatment for chronic GVHD. It's a phase 2 randomized trial where participants are randomly assigned to receive either Ruxolitinib or Prednisone to evaluate effectiveness and safety.
What are the potential side effects?
Possible side effects of Ruxolitinib include infection risk, low blood counts, dizziness, and headaches. Prednisone may cause weight gain, mood swings, high blood pressure, and increased blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can care for myself but may need occasional help.
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My blood counts and kidney function are within the required ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have active hepatitis B, C, or HIV.
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I am not pregnant or breastfeeding.
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I have or had active Tuberculosis.
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I do not have serious or unmanaged heart problems.
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My cancer has returned after a transplant.
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I have been treated with immune suppressive therapy for chronic GVHD.
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I do not have any infections that aren't under control.

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
Treatment Success
Secondary study objectives
Treatment Success Rate

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%
Haematoma
7%
Dyslipidaemia
7%
Pain in extremity
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%
Paraesthesia
3%
Bronchitis
3%
Cystitis
3%
Blood creatine phosphokinase increased
3%
Skin ulcer
3%
Abdominal pain upper
3%
Pulmonary embolism
3%
Pneumonia
3%
Influenza
3%
Myalgia
3%
Urinary tract infection
3%
Depression
2%
Acute pulmonary oedema
2%
Peripheral artery thrombosis
2%
Vertigo
2%
Night sweats
2%
Intervertebral disc protrusion
2%
Urethral stenosis
2%
Ureterolithiasis
2%
Localised infection
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

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ruxolitinib Treatment ArmExperimental Treatment1 Intervention
Ruxolitinib is administered as 10 mg orally twice daily in 28-day cycles.
Group II: Prednisone Treatment ArmActive Control1 Intervention
Prednisone will be started at 1mg/kg/day based on patient current body weight in kilograms.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1170

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
561 Previous Clinical Trials
144,710 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
391 Previous Clinical Trials
63,715 Total Patients Enrolled
Farhad Khimani, MDPrincipal InvestigatorMoffitt Cancer Center
~80 spots leftby Nov 2028
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