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Bruton's Tyrosine Kinase (BTK) Inhibitor
Ibrutinib for Chronic Graft-versus-Host Disease
Phase 2
Recruiting
Led By Steven Z Pavletic, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of prior allogeneic Hematopoietic Stem Cell Transplant (HSCT) (any donors, conditioning regimens and graft sources are allowed)
Newly diagnosed moderate or severe chronic Graft versus Host Disease (GvHD) (according to the 2014 NIH Consensus Criteria, requiring systemic immunosuppression)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will test whether ibrutinib can help people with newly diagnosed cGVHD.
Who is the study for?
Adults over 18 with newly diagnosed moderate or severe chronic Graft-versus-Host Disease after a stem cell or bone marrow transplant can join. They must be responding to current treatments, agree to use birth control, and have no uncontrolled infections, bleeding disorders, other cancers (with some exceptions), heart issues, hepatitis B/C, or known allergy to Ibrutinib.Check my eligibility
What is being tested?
The trial is testing if Ibrutinib can help as a first-line treatment for cGVHD without needing steroids. Participants will take the drug daily for up to two years and attend regular check-ups including physical exams and lung function tests while keeping a medicine diary.See study design
What are the potential side effects?
Ibrutinib may cause side effects such as diarrhea, muscle pain, rash, fever; it might also affect blood counts leading to increased bruising or risk of infection. Heart rhythm problems are possible too.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a stem cell transplant from a donor.
Select...
I have been newly diagnosed with moderate or severe chronic GvHD and need systemic immunosuppression.
Select...
I am 18 years old or older.
Select...
I can care for myself but may need occasional help.
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
To evaluate the efficacy of ibrutinib as a first-line treatment for persons with newly diagnosed chronic graft-versus-host disease (GvHD) by measuring the overall response rate
Secondary outcome measures
To evaluate 24 months post-treatment follow-up for survival
To evaluate failure-free survival (FFS)
To evaluate safety of ibrutinib for newly diagnosed chronic GvHD
Side 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%
Actinic keratosis
5%
Dermatitis
5%
Stomatitis
5%
Gingival bleeding
5%
Rhinorrhoea
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%
Haemolytic anaemia
1%
Wheezing
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: InterventionExperimental Treatment1 Intervention
Determine response rate via continuous daily dose by mouth to determine efficacy
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?
National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,608 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
236 Patients Enrolled for Graft-versus-Host Disease
Steven Z Pavletic, M.D.Principal InvestigatorNational Cancer Institute (NCI)
15 Previous Clinical Trials
3,763 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any uncontrolled infections or bleeding disorders.I have had a stem cell transplant from a donor.My cancer has returned or worsened.The researchers can decide not to include you for other reasons and they will write it down in your medical record.I have been newly diagnosed with moderate or severe chronic GvHD and need systemic immunosuppression.Your test results must be within certain ranges.I am 18 years old or older.My doses of immunosuppressive medications have been stable for the last 2 weeks.I have severe liver problems (Child-Pugh class C).I have symptoms like skin rash, liver issues, or diarrhea but they are getting better with treatment.I have been treated for chronic GvHD with drugs other than a specific dose of prednisone.I can care for myself but may need occasional help.I have had cancer before, but it might be an exception.My heart does not function properly.You are allergic to ibrutinib.I have hepatitis B or C.I have not taken certain medications recently.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
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.
Is Ibrutinib a dependable therapy for patient use?
"Due to limited evidence in regards to efficacy, our team at Power assigned the safety of Ibrutinib a score of 2 on their scale. There is some data that supports its safety however."
Answered by AI
Are there any pre-existing investigations involving Ibrutinib?
"The National Institutes of Health Clinical Centre in Bethesda, Maryland has been researching ibrutinib since 2011. To date there have been 97 completed studies and a total 155 active clinical trials being conducted at the same location."
Answered by AI
To what extent is this clinical trial active in terms of patient involvement?
"Affirmative. The clinicaltrials.gov website notes that this research endeavour, which was initially posted on May 10th 2021, is currently recruiting participants. Approximately 40 volunteers need to be sourced from 3 separate centres."
Answered by AI
Is recruiting currently underway for this research endeavor?
"According to clinicaltrials.gov, this current medical trial is still recruiting; it first opened on May 10th 2021 and has been revised most recently on November 22nd 2022."
Answered by AI
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