← Back to Search

Immunomodulator

Ruxolitinib for Chronic Graft-versus-Host Disease

Phase 1
Recruiting
Led By Pooja Khandelwal, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient aged ≥12 year-old and ≤30 year-old
No active, clinically significant uncontrolled infections
Must not have
Clinical evidence suggesting active malignancy (including PTLD and primary/secondary malignancy)
ESRD [CLcr < 15 mL/min] not on dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

"This trial is studying the effectiveness of a new drug called ruxolitinib in treating chronic graft versus host disease (cGVHD) which is a common complication after a stem cell transplant. R

Who is the study for?
This trial is for individuals who have received a stem cell transplant and are now dealing with chronic graft versus host disease (cGVHD), which can affect various organs. Participants should not have previously used high-dose steroids or other immunosuppressants for cGVHD.
What is being tested?
The study is testing the effectiveness of Ruxolitinib as an initial, standalone treatment for cGVHD. The goal is to see if using this drug early on, without combining it with steroids, can help manage symptoms better.
What are the potential side effects?
Ruxolitinib may cause side effects such as infections due to a weakened immune system, bleeding problems, dizziness upon standing up too fast, headache and possible increase in cholesterol levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 12 and 30 years old.
Select...
I do not have any serious or uncontrolled infections.
Select...
I am on a low dose of steroids.
Select...
I have a new diagnosis of severe chronic graft versus host disease needing treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have signs of active cancer.
Select...
My kidneys are very weak, and I am not on dialysis.
Select...
My blood counts are low and not improving with standard care.
Select...
I am currently experiencing bleeding from my lower GI tract.
Select...
I have been treated with high-dose steroids for a condition after a transplant.
Select...
I have acute GVHD without signs of chronic GVHD.
Select...
I am taking a high dose of steroids at the time of enrollment.
Select...
I currently have a serious infection.
Select...
I have not had a clot-related event like a heart attack or stroke in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

1Treatment groups
Experimental Treatment
Group I: Ruxolitinib TreatmentExperimental Treatment1 Intervention
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?

Children's Hospital Medical Center, CincinnatiLead Sponsor
837 Previous Clinical Trials
6,565,313 Total Patients Enrolled
Pooja Khandelwal, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
6 Previous Clinical Trials
387 Total Patients Enrolled
~20 spots leftby Jun 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top