Your session is about to expire
← Back to Search
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 7 years
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 moreSide effects data
From 2022 Phase 3 trial • 201 Patients • NCT0305344037%
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%
Onychoclasis
10%
Pain in extremity
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%
Conjunctival haemorrhage
6%
Pruritus
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%
Stomatitis
5%
Actinic keratosis
5%
Gingival bleeding
5%
Rhinorrhoea
5%
Dermatitis
5%
Mouth ulceration
5%
Onychomycosis
5%
Petechiae
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%
Haemorrhoids
4%
Vertigo
4%
Ecchymosis
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%
Abdominal distension
3%
Rotator cuff syndrome
3%
Dysuria
3%
Pollakiuria
3%
Dry eye
3%
Osteoporosis
3%
Bladder transitional cell carcinoma
3%
Tinnitus
3%
Inguinal hernia
3%
Hypoalbuminaemia
3%
Erythema
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%
Haemorrhagic disorder
1%
Wound infection staphylococcal
1%
Cardiac failure acute
1%
Viral infection
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 3
~1880
Find a Location
Who is running the clinical trial?
Pharmacyclics LLC.Lead Sponsor
113 Previous Clinical Trials
13,761 Total Patients Enrolled
Janssen Research & Development, LLCIndustry Sponsor
975 Previous Clinical Trials
6,384,249 Total Patients Enrolled
Justin Wahlstrom, MDStudy DirectorPharmacyclics LLC.
2 Previous Clinical Trials
383 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can care for myself but may need occasional help.I have chronic GVHD that didn't improve after at least one treatment.I have a known bleeding disorder.My cancer is getting worse or I have a disease after a transplant.I have a new, severe immune reaction after a transplant needing strong medication.I have had a stem cell transplant from a donor.I am between 1 and 11 years old for Part A, or between 1 and 21 for Part B.My chronic GVHD is only affecting one of my genito-urinary organs.I received a donor lymphocyte infusion less than 8 weeks ago.I do not have any ongoing infections that require continuous treatment.I have active hepatitis B or C.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1/2
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.
What are the qualifying factors for participating in this research?
"This particular clinical study only accept patients that have graft vs host disease and are between 1 year to 21 years old. A total of 59 participants can be enrolled in the trial."
Answered by AI
Can you tell me about other times Ibrutinib has been tested in a clinical setting?
"The original research on ibrutinib was conducted in 2011 at the National Institutes of Health Clinical Center. Since then, 97 similar studies have been completed with 158 more presently underway. Many of these active trials are based in San Diego, California."
Answered by AI
Are octogenarians being sought for this research project?
"According to the eligibility requirements posted for this research, applicants must be aged 1-21 years old. Out of the 476 total clinical trials that are currently underway, 73 specifically involve minors and 303 focus on patients over 65 years old."
Answered by AI
Can people sign up for this experiment right now?
"The clinical trial mentioned is not presently looking for participants, as reflected on clinicaltrials.gov. This specific study was first posted on November 19th, 2018 and updated most recently on July 15th, 2022. There are 332 other trials which are recruiting patients."
Answered by AI
Is this clinical trial taking place in numerous hospitals throughout the state?
"22 hospitals are running this trial currently. If you want to participate in the study and minimize travel, it is best to choose a site near your location from the list of 22 locations which include San Diego, Cincinnati and Seattle among others."
Answered by AI
What is the absolute most people that can be in this trial?
"This particular study is no longer recruiting patients, as seen on clinicaltrials.gov. The trial was first posted on November 19th, 2018 and updated for the last time on July 15th, 2022. However, there are currently 174 other trials related to graft vs host disease and 158 for Ibrutinib that are still admitting patients."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger