Your session is about to expire
← Back to Search
Extended Ibrutinib Treatment for Non-Hodgkin's Lymphoma
Phase 4
Waitlist Available
Research Sponsored by Pharmacyclics Switzerland GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ongoing continuous treatment with ibrutinib
Subject must have completed all assessments in their parent protocol and want to continue treatment with ibrutinib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years and will be re-evaluated.
Awards & highlights
Study Summary
This trial provides continued access to ibrutinib for those who have completed parent ibrutinib studies and are still benefitting, but have no access to commercial ibrutinib.
Who is the study for?
This trial is for patients already in an ibrutinib study who've seen benefits but can't get the drug commercially. They must have finished all previous study requirements, agree to birth control methods, and not be pregnant or planning pregnancy.Check my eligibility
What is being tested?
The trial provides ongoing access to ibrutinib for those benefiting from it after completing prior studies. It's open-label and multicenter, meaning both doctors and participants know they're getting ibrutinib, at various locations.See study design
What are the potential side effects?
While specific side effects are not listed here, Ibrutinib may commonly cause diarrhea, bleeding problems, infections, fatigue, muscle and bone pain among other potential side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently on continuous treatment with ibrutinib.
Select...
I have finished all tests in my current treatment plan and wish to keep taking ibrutinib.
Select...
I cannot get the drug ibrutinib where I live.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years and will be re-evaluated.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years and will be re-evaluated.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The objective of protocol PCYC-1145-LT is to provide long-term access to ibrutinib for subjects who meet the selection criteria.
Secondary outcome measures
Characterize the drug safety profile by collecting long-term safety data for ibrutinib.
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%
Pain in extremity
10%
Onychoclasis
10%
Fall
10%
Oropharyngeal pain
10%
Lower respiratory tract infection
10%
Sinusitis
10%
Palpitations
9%
Hyperuricaemia
9%
Nasopharyngitis
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%
Gingival bleeding
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%
Dysuria
3%
Pollakiuria
3%
Dry eye
3%
Osteoporosis
3%
Bladder transitional cell carcinoma
3%
Hypoalbuminaemia
3%
Inguinal hernia
3%
Rotator cuff syndrome
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%
Wound infection staphylococcal
1%
Viral infection
1%
Cardiac failure acute
1%
Haemorrhagic disorder
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: IbrutinibExperimental Treatment1 Intervention
Treatment with Ibrutinib, once daily until disease progression or unacceptable toxicity.
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 Switzerland GmbHLead Sponsor
1 Previous Clinical Trials
74 Total Patients Enrolled
Janssen Biotech, Inc., including Johnson & JohnsonUNKNOWN
Bernhard Hauns, MDStudy DirectorPharmacyclics LLC.
2 Previous Clinical Trials
255 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow all study requirements.I am currently on continuous treatment with ibrutinib.I plan to try for a child during or within 3 months after the study.I am not pregnant, breastfeeding, nor planning to become pregnant soon.I have finished all tests in my current treatment plan and wish to keep taking ibrutinib.I agree to use effective birth control and a barrier method during and for 90 days after treatment.I understand the study's risks and can sign the consent form.I cannot get the drug ibrutinib where I live.
Research Study Groups:
This trial has the following groups:- Group 1: Ibrutinib
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Has Ibrutinib gained official authorization from the Food and Drug Administration?
"There is ample evidence of ibrutinib's efficacy, giving it a rating of 3 on Power's scale. This drug has also been approved for use by the relevant health authorities."
Answered by AI
What is the maximum enrollment limit for this research project?
"This clinical trial is not currently open for enrollment. It was published on May 22nd 2017 and modified on November 19th 2022. Alternately, there are 2351 trials actively recruiting patients with diffuse lymphoma and 155 studies looking to enroll people taking Ibrutinib."
Answered by AI
Are there any other investigations that have explored the efficacy of Ibrutinib?
"Initially studied in 2011 at National Institutes of Health Clinical Center, 9000 Rockville Pike, ibrutinib has since been the subject of 96 completed studies. Moreover, there are currently 155 active trials actively taking place with a noteworthy number being conducted out of Tyler, Texas."
Answered by AI
Are there any healthcare facilities in this state that have been authorized to initiate the clinical trial?
"The clinical trial is available at a number of sites, including Texas Oncology in Tyler, University of Pittsburgh Medical Center in Pittsburgh and University of Michigan Health System in Ann Arbor. Additional medical centres are also joining the study."
Answered by AI
Is the enrollment process for this research still open?
"Unfortunately, no more participants are being accepted into this investigation. It was originally posted on May 22nd 2017, and the trial's details were last edited on November 19th 2022. However, there is hope; currently 2351 clinical trials for diffuse lymphoma require volunteers as do 155 studies focused on Ibrutinib."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger