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Janus Kinase Inhibitor

Ruxolitinib for Lung Dysfunction Post Stem Cell Transplant (HSCT Trial)

Phase 2
Recruiting
Led By Kasiani Myers, 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
Subjects ≥ 5 years and ≤ 60 years of age who have undergone allogeneic HCT AND exhibit early lung dysfunction as defined by specific criteria
Adequate renal function defined as estimated Creatinine Clearance (CrCl) ≥ 30 mL/min
Must not have
Active uncontrolled pulmonary infection
Subjects who are pregnant or breastfeeding or are at risk of pregnancy or fathering a baby and are unable to use acceptable highly effective method of birth control
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months from early lung dysfunction diagnosis
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a new combination of drugs can help treat a common and serious side effect of a stem cell transplant that often leads to long-term problems or even death.

Who is the study for?
This trial is for people aged 5 to 60 who've had a bone marrow transplant and are showing early signs of lung problems. They need good blood, kidney, and liver function. It's not for those allergic to the study drug, pregnant or breastfeeding individuals without birth control, or anyone treated with other experimental drugs for graft-versus-host disease in the last month.
What is being tested?
The trial tests if adding Ruxolitinib to standard treatments like Flovent/montelukast and steroids can reverse early lung damage after a stem cell transplant. The goal is to prevent chronic lung issues or severe Bronchiolitis Obliterans by treating it sooner.
What are the potential side effects?
Ruxolitinib may cause side effects such as infections due to low blood counts, bleeding problems from changes in clotting times, kidney function alterations, and potential liver enzyme abnormalities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 5 and 60 years old and have had a stem cell transplant with early lung issues.
Select...
My kidneys are working well enough (CrCl ≥ 30 mL/min).
Select...
My blood tests for immune cells, clotting, and platelets are within normal ranges.
Select...
My liver is functioning well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I currently have a lung infection that is not under control.
Select...
I am not pregnant, breastfeeding, or at risk of becoming pregnant or fathering a child, or I can use effective birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months from early lung dysfunction diagnosis
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months from early lung dysfunction diagnosis for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with ruxolitinib treatment response
Secondary study objectives
Number of participants with lung function response measured by a Xenon MRI scan
Number of participants with lung function response measured by home spirometry
Number of participants with lung function response measured by oscillometry
+1 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%
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
6,565,297 Total Patients Enrolled
6 Trials studying Bronchiolitis Obliterans Syndrome
2,107 Patients Enrolled for Bronchiolitis Obliterans Syndrome
Kasiani Myers, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
2 Previous Clinical Trials
24 Total Patients Enrolled

Media Library

Ruxolitinib (Janus Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04908735 — Phase 2
Bronchiolitis Obliterans Syndrome Research Study Groups: Ruxolitinib Treatment
Bronchiolitis Obliterans Syndrome Clinical Trial 2023: Ruxolitinib Highlights & Side Effects. Trial Name: NCT04908735 — Phase 2
Ruxolitinib (Janus Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04908735 — Phase 2
~9 spots leftby Nov 2025
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