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Janus Kinase (JAK) Inhibitor
Ruxolitinib for Graft-versus-Host Disease
Phase 1
Waitlist Available
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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is researching whether a drug called ruxolitinib can help treat acute and chronic graft versus host disease.
Eligible Conditions
- Graft-versus-Host Disease
- Solid Organ Transplant
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cmax of ruxolitinib in existing patients with chronic GVHD (Arm 1)
Graft-vs-Host Disease
Cmax of ruxolitinib in patients with new onset chronic GVHD (Arm 3)
+1 moreSecondary outcome measures
Incidence of infections (Arm 1)
Incidence of infections (Arm 2)
Incidence of infections (Arm 3)
+15 moreSide effects data
From 2020 Phase 3 trial • 149 Patients • NCT0203803633%
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%
Blood creatine phosphokinase increased
3%
Cystitis
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%
Urethral stenosis
2%
Night sweats
2%
Acute pulmonary oedema
2%
Intervertebral disc protrusion
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
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 3: New onset chronic GVHD ages 0-≤18 yearsExperimental Treatment1 Intervention
Participants with new onset chronic GVHD will receive ruxolitinib on this arm.
Group II: Arm 2: Acute GVHD ages 0-<12 yearsExperimental Treatment1 Intervention
Participants with acute GVHD will receive ruxolitinib on this arm.
Group III: Arm 1: Existing patients with chronic GVHDActive Control1 Intervention
Participants with established diagnosis of chronic GVHD and currently on treatment with ruxolitinib for chronic GVHD for at least 3 weeks. Participants in this arm are receiving ruxolitinib clinically and will not receive ruxolitinib as part of this research study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1140
Find a Location
Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,583 Total Patients Enrolled
Pooja Khandelwal, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
4 Previous Clinical Trials
164 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Children under the age of 12 who have received a transplant of stem cells or an organ from another person are excluded.You have symptoms that resemble a combination of acute and chronic graft-versus-host disease.Children may not be able to do breathing tests to check for lung GVHD, so we will use other criteria to diagnose it. But, even if you don't have lung problems, you can still participate in the study if you meet other requirements and receive ruxolitinib.You have been diagnosed with chronic graft-versus-host disease (GVHD), regardless of severity.You have an ongoing condition called graft-versus-host disease (GVHD) in another part of your body, and you are experiencing respiratory symptoms such as rapid breathing, increased need for oxygen, and coughing.All levels of GVHD (a complication that can occur after a stem cell transplant) are allowed.You have been taking ruxolitinib for at least three weeks to treat chronic GVHD.You can continue to use certain local treatments like steroid creams or eye drops while taking ruxolitinib. Other treatments may be allowed with approval from the study's principal investigator.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Existing patients with chronic GVHD
- Group 2: Arm 2: Acute GVHD ages 0-<12 years
- Group 3: Arm 3: New onset chronic GVHD ages 0-≤18 years
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being recruited for participation in this clinical trial?
"Affirmative. Per the information provided on clinicaltrials.gov, this research initiative is currently recruiting participants; it was initially posted in October 2021 and last updated in March 2022, with a requirement for 28 patients from 1 centre."
Answered by AI
Is Ruxolitinib a secure medication for individuals?
"Due to the limited clinical data available for Ruxolitinib, our team at Power estimates its safety on a scale of 1-3 as a level 1."
Answered by AI
Are there any current openings for participants in this research?
"Affirmative. The clinicaltrials.gov listing indicates that the trial is actively recruiting; it was published on October 27th 2021 and underwent its most recent update on March 31st 2022. 28 patients must be recruited from a single site for this study to move forward as planned."
Answered by AI
What conditions does Ruxolitinib typically serve to alleviate?
"Patients with polycythemia vera, polycythemia, or those who cannot tolerate hydroxyurea may receive therapeutic relief via Ruxolitinib."
Answered by AI
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