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Bruton's Tyrosine Kinase Inhibitor

Ibrutinib for Graft-versus-Host Disease

Phase 1 & 2
Waitlist Available
Research Sponsored by Pharmacyclics LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky or Lansky (subjects <16 years of age) performance status ≥60
Subjects with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 7 years
Awards & highlights

Study Summary

This trial is to study the side effects and best dose of ibrutinib in children with cGVHD.

Who is the study for?
This trial is for children and young adults who have chronic Graft Versus Host Disease (cGVHD) after a stem cell transplant. It's open to those aged 1-12 for Part A, and 1-22 for Part B, who've tried at least one treatment without success or are newly diagnosed needing systemic therapy. Participants should be fairly active (performance status ≥60). Those with uncontrolled infections, hepatitis, only genito-urinary cGVHD, recent investigational drugs or donor lymphocyte infusions can't join.Check my eligibility
What is being tested?
The study is testing the safety and appropriate dosing of Ibrutinib in pediatric patients with cGVHD. This phase involves finding the right dose (Phase 1) and then checking its safety profile more broadly (Phase 2).See study design
What are the potential side effects?
Ibrutinib may cause side effects such as bleeding problems, infections due to weakened immune responses, diarrhea, muscle pains, and rashes. The severity of these side effects varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may need occasional help.
Select...
I have chronic GVHD that didn't improve after at least one treatment.
Select...
I have a new, severe immune reaction after a transplant needing strong medication.
Select...
I have had a stem cell transplant from a donor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 7 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
Number of patients with adverse events as a measure of safety and tolerability
Part A- PK (measured by AUC) will be reported descriptively
Part B- PK (measured by AUC) will be reported descriptively
Secondary outcome measures
Available immune reconstitution laboratory parameters will be reported descriptively
Growth Parameter height in meters will be reported descriptively
Growth Parameter weight in kilograms will be reported descriptively.
+7 more

Side effects data

From 2022 Phase 3 trial • 201 Patients • NCT03053440
37%
Diarrhoea
32%
Upper respiratory tract infection
29%
Muscle spasms
28%
Contusion
24%
Arthralgia
24%
Hypertension
22%
Oedema peripheral
22%
Anaemia
21%
Epistaxis
20%
Cough
19%
Rash
19%
Fatigue
18%
Back pain
18%
Atrial fibrillation
17%
Urinary tract infection
16%
Neutropenia
16%
Thrombocytopenia
15%
Nausea
15%
Headache
15%
Vomiting
14%
Pneumonia
14%
Dizziness
13%
Haematuria
12%
Peripheral swelling
12%
Pyrexia
12%
Constipation
11%
Localised infection
10%
Pain in extremity
10%
Onychoclasis
10%
Fall
10%
Oropharyngeal pain
10%
Lower respiratory tract infection
10%
Sinusitis
10%
Palpitations
9%
Nasopharyngitis
9%
Hyperuricaemia
9%
Insomnia
9%
Dyspnoea
9%
Haematoma
8%
Skin laceration
8%
Paraesthesia
7%
Dry skin
7%
Dyspepsia
7%
Cellulitis
7%
Conjunctivitis
7%
Skin infection
7%
Iron deficiency
7%
Anxiety
7%
Rhinitis
6%
Cataract
6%
Pruritus
6%
Conjunctival haemorrhage
6%
Hypokalaemia
6%
Syncope
6%
Vision blurred
6%
Abdominal pain
6%
Abdominal pain upper
6%
Nail infection
6%
Neck pain
6%
Purpura
6%
Asthenia
5%
Dermatitis
5%
Gingival bleeding
5%
Actinic keratosis
5%
Stomatitis
5%
Rhinorrhoea
5%
Petechiae
5%
Mouth ulceration
5%
Onychomycosis
5%
Abdominal discomfort
5%
Chest pain
5%
Influenza like illness
5%
COVID-19
5%
Gastroenteritis
5%
Tooth infection
5%
Limb injury
5%
Squamous cell carcinoma of skin
5%
Peripheral sensory neuropathy
5%
Rosacea
5%
Increased tendency to bruise
5%
Gout
5%
Basal cell carcinoma
5%
Folliculitis
5%
Oral herpes
5%
Gastrooesophageal reflux disease
4%
Ecchymosis
4%
Haemorrhoids
4%
Vertigo
4%
Sepsis
4%
Angina pectoris
4%
Retinal haemorrhage
4%
Dry mouth
4%
Chills
4%
Bronchitis
4%
Furuncle
4%
Joint injury
4%
Blood alkaline phosphatase increased
4%
Neutrophil count decreased
4%
Decreased appetite
4%
Joint swelling
4%
Depression
4%
Productive cough
4%
Skin ulcer
4%
Atrial flutter
4%
Hyperglycaemia
4%
Herpes zoster
3%
Erythema
3%
Tinnitus
3%
Abdominal distension
3%
Dry eye
3%
Hypoalbuminaemia
3%
Dysuria
3%
Pollakiuria
3%
Bladder transitional cell carcinoma
3%
Osteoporosis
3%
Rotator cuff syndrome
3%
Inguinal hernia
3%
Acute myocardial infarction
3%
Sinus bradycardia
3%
Dysphagia
3%
Malaise
3%
Cystitis
3%
Alanine aminotransferase increased
3%
Gamma-glutamyltransferase increased
3%
Musculoskeletal chest pain
3%
Seborrhoeic keratosis
3%
Neuralgia
3%
Benign prostatic hyperplasia
3%
Dyspnoea exertional
3%
Nasal congestion
3%
Pneumonitis
3%
Psoriasis
3%
Skin fissures
3%
Skin lesion
3%
Laryngitis
3%
Respiratory tract infection
3%
Bradycardia
3%
Acute kidney injury
3%
Wound infection
3%
Myalgia
3%
Skin toxicity
3%
Ear infection
3%
Paronychia
3%
Osteoarthritis
3%
Pericarditis
3%
Sciatica
3%
Ocular hyperaemia
3%
Nail disorder
2%
Rectal haemorrhage
2%
Cholecystitis
2%
COVID-19 pneumonia
2%
Pleural effusion
2%
Drug withdrawal syndrome
2%
Seasonal allergy
2%
Vitamin D deficiency
2%
Rash maculo-papular
2%
Hypotension
2%
Death
2%
Loss of consciousness
1%
Wheezing
1%
Haemolytic anaemia
1%
Wound infection staphylococcal
1%
Haemorrhagic disorder
1%
Viral infection
1%
Cardiac failure acute
1%
Colitis
1%
Oral blood blister
1%
Upper gastrointestinal haemorrhage
1%
Drug-induced liver injury
1%
Bacterial sepsis
1%
Brain abscess
1%
Device related infection
1%
Gastrointestinal infection
1%
Neurocryptococcosis
1%
Septic shock
1%
Streptococcal bacteraemia
1%
Femoral neck fracture
1%
Femur fracture
1%
Lumbar vertebral fracture
1%
Post procedural haemorrhage
1%
Stress fracture
1%
Subdural haematoma
1%
Lethargy
1%
Subarachnoid haemorrhage
1%
Chronic kidney disease
1%
Urinary bladder haemorrhage
1%
Prostatitis
1%
Acute pulmonary oedema
1%
Laryngeal oedema
1%
Hyponatraemia
1%
Muscular weakness
1%
Rash erythematous
1%
Hyperviscosity syndrome
1%
Melaena
1%
Clostridium difficile infection
1%
Post procedural sepsis
1%
Pyelonephritis
1%
Cerebrovascular accident
1%
Respiratory disorder
1%
Lymphadenopathy
1%
Streptococcal sepsis
1%
Amyloidosis
1%
Influenza
1%
Pneumonia viral
1%
Coronary artery disease
1%
Pericardial haemorrhage
1%
Urosepsis
1%
Spinal stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Ibrutinib
Arm B: Zanubrutinib

Trial Design

1Treatment groups
Experimental Treatment
Group I: Phase 1/2Experimental Treatment1 Intervention
Part A: Subjects ≥1 to <12 years of age with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy, will receive oral ibrutinib once daily to determine Recommended Pediatric Equivalent Dose (RPED). Part A Continuation: Subjects participating in Part A may continue receiving daily ibrutinib until the RPED is determined, at which time their dose may be adjusted to the RPED. Part B: Subjects ≥1 to <12 years of age( upper age limit is < 22 years) with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy or with newly diagnosed moderate or severe cGVHD will be dosed at the RPED. Subjects ≥12 will be given 420mg orally ibrutinib once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 4
~1890

Find a Location

Who is running the clinical trial?

Pharmacyclics LLC.Lead Sponsor
113 Previous Clinical Trials
13,756 Total Patients Enrolled
Janssen Research & Development, LLCIndustry Sponsor
978 Previous Clinical Trials
6,385,010 Total Patients Enrolled
Justin Wahlstrom, MDStudy DirectorPharmacyclics LLC.
2 Previous Clinical Trials
383 Total Patients Enrolled

Media Library

Ibrutinib (Bruton's Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03790332 — Phase 1 & 2
Graft-versus-Host Disease Research Study Groups: Phase 1/2
Graft-versus-Host Disease Clinical Trial 2023: Ibrutinib Highlights & Side Effects. Trial Name: NCT03790332 — Phase 1 & 2
Ibrutinib (Bruton's Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03790332 — Phase 1 & 2
~13 spots leftby Jan 2026
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