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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months from early lung dysfunction diagnosis

Awards & highlights

HSCT Trial 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.Check my eligibility

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.See study design

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.

HSCT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

HSCT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months from early lung dysfunction diagnosis

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with ruxolitinib treatment response

Secondary outcome measures

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

Thrombocytosis

Upper respiratory tract infection

Hypercholesterolaemia

Dyslipidaemia

Pain in extremity

Haematoma

Abdominal discomfort

Diarrhoea

Dyspepsia

Vomiting

Blood lactate dehydrogenase increased

Memory impairment

Dyspnoea

Tinnitus

Osteoarthritis

Leukocytosis

Thrombocytopenia

Flatulence

Nausea

Sinusitis

Basal cell carcinoma

Neuropathy peripheral

Hyperuricaemia

Paraesthesia

Cystitis

Bronchitis

Blood creatine phosphokinase increased

Skin ulcer

Abdominal pain upper

Pulmonary embolism

Pneumonia

Influenza

Myalgia

Urinary tract infection

Depression

Localised infection

Intervertebral disc protrusion

Urethral stenosis

Night sweats

Acute pulmonary oedema

Vertigo

Peripheral artery thrombosis

Ureterolithiasis

Pericardial effusion

Acute myocardial infarction

Syncope

Gastrooesophageal reflux disease

General physical health deterioration

Atrial fibrillation

Cardiac disorder

Mitral valve incompetence

Vertigo positional

Retinal artery occlusion

Visual acuity reduced

Gastrointestinal haemorrhage

Oesophageal varices haemorrhage

Lower respiratory tract infection

Pyelonephritis

Respiratory tract infection

Sepsis

Tendon rupture

Ulna fracture

Weight decreased

Decreased appetite

Hyponatraemia

Blast cell crisis

Bone marrow tumour cell infiltration

Lung adenocarcinoma

Metastases to spine

Myelofibrosis

Prostatic adenoma

Squamous cell carcinoma of skin

Nephrolithiasis

Gamma-glutamyltransferase increased

Haematocrit increased

Musculoskeletal pain

Ischaemic stroke

Diabetes mellitus

100%

80%

60%

40%

20%

Study treatment Arm

All Crossover Patients

Best Available Therapy

Ruxolitinib

HSCT 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

~1140

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,551 Total Patients Enrolled

4 Trials studying Bronchiolitis Obliterans Syndrome

2,064 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

Frequently Asked Questions

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

Has the US food and drug administration cleared Ruxolitinib for public use?

"At Power, we gave Ruxolitinib a 2 for safety. This is because, although there is some data supporting its safety, none of it speaks to the medication's efficacy."

Answered by AI

Are there any available openings for patients who want to enroll in this research?

"Yes, this trial is still recruiting patients. The information on clinicaltrials.gov shows that the study was posted on 11/12/2021 and last edited on 8/6/2022."

Answered by AI

What medical condition does Ruxolitinib help to improve?

"Ruxolitinib is not only useful in treating polycythemia vera, but also for patients that have primary myelofibrosis or are resistant to hydroxyurea."

Answered by AI

Which type of person would be a good candidate to participate in this research?

"This trial is currently seeking 40 bronchiolitis patients aged 5-25. Key inclusion criteria are as follows: a 10% decrease in FEV1 from baseline or 25% reduction of FEF 25-75, active GVHD impacting another organ with pulmonary symptoms (tachypnea, new oxygen requirement, cough), R5 increase by 50%, air trapping on CT scan, small airway thickening or bronchiectasis, adequate renal function (CrCl ≥ 30 mL/min), ALT and AST ≤ 5 x ULN unless due to cGVHD, total bilirubin ≤ 5 x UNL or"

Answered by AI