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Janus Kinase (JAK) Inhibitor

Ruxolitinib for Graft-versus-Host Disease

Phase 1 & 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new drug to treat graft-versus-host disease (aGvHD) or severe refractory aGvHD (SR-aGvHD) in children. The drug, ruxolitinib, will be added to the patient's existing immunosuppressive regimen. The trial will enroll patients in four age groups, from 28 days to 18 years old. The trial will assess the safety and efficacy of the drug in this population.

Eligible Conditions
  • Graft-versus-Host Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, 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
Phase I: Age-based determination of recommended phase 2 dose (RP2D) for each of the groups 2-4
Phase I: Measurement of PK parameter, Cmax, in aGvHD and SR-aGvHD patients
Phase I: Measurement of PK parameter, Ctrough, in aGvHD and SR-aGvHD patients
+3 more
Secondary outcome measures
Duration of response (DOR)
Event-Free Survival (EFS)
Failure-Free Survival (FFS)
+19 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

1Treatment groups
Experimental Treatment
Group I: RuxolitinibExperimental Treatment1 Intervention
All patients received ruxolitinib in addition to corticosteroids +/-calcineurin inhibitor (CNI)
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?

Novartis PharmaceuticalsLead Sponsor
2,857 Previous Clinical Trials
4,197,756 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
127 Patients Enrolled for Graft-versus-Host Disease

Frequently Asked Questions

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

What are the objectives of this research project?

"This clinical trial, with a 28-day window of observation, seeks to measure the pharmacokinetic parameters in those suffering from acute Graft versus Host Disease (aGvHD) and steroid refractory aGVHD. Secondary objectives include: recording weekly cumulative doses of steroids; determining Failure-Free Survival (FFS); and assessing Percentage Response Rates (PRR)."

Answered by AI

What is the current quota for enrollment in this clinical trial?

"At this time, enrollment for the clinical trial has closed. Initially posted on February 21st 2019, with its latest update coming November 3rd 2022; it is no longer accepting participants. However, if you are seeking other studies to join there currently exists 171 trials recruiting patients suffering from graft-v.-host disease and 97 trials actively admitting individuals receiving Ruxolitinib treatment."

Answered by AI

Does this research project accept minors as participants?

"This clinical trial has an age range of 28 days to 17 years old, as specified by the inclusion criteria."

Answered by AI

What therapeutic applications is Ruxolitinib deployed for?

"Ruxolitinib has been approved to treat polycythemia vera. This drug can also be used as a therapeutic option for those with hydroxyurea-resistant or -intolerant polycythemia and primary myelofibrosis."

Answered by AI

Could you provide information regarding available slots in this research endeavor?

"Clinicaltrials.gov indicates that this research study is not presently enrolling patients, even though it was initially posted in February 2019 and most recently edited November 3rd 2022. However, there are 268 other active clinical trials with immediate recruitment needs."

Answered by AI

May I be considered for inclusion in this research project?

"This trial is searching for 45 individuals between infancy and 17 years of age who suffer from graft-vs-host disease. The desired participants must have received alloSCT bone marrow, peripheral blood stem cells, or cord blood via matched unrelated donor, sibling, haplo-identical methods with myeloablative or reduced intensity conditioning."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Pharmacokinetics, Activity and Safety of Ruxolitinib in Pediatric Patients With Grade II-IV Acute Graft vs. Host Disease
2019. "Study of Pharmacokinetics, Activity and Safety of Ruxolitinib in Pediatric Patients With Grade II-IV Acute Graft vs. Host Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03491215.
~7 spots leftby Apr 2025
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