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Kinase Inhibitor
Long-term Ibrutinib for Lymphoma (CAN3001 Trial)
Phase 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to the end-of-treatment visit (up to 30 days after the last dose of study medication), or until the start of a subsequent anti-caner therapy, if earlier
Awards & highlights
CAN3001 Trial Summary
This trial will provide long-term safety and efficacy data for people taking ibrutinib, as well as continuing access to the drug for people who have benefited from it in the past.
Who is the study for?
This trial is for patients already enrolled in completed ibrutinib studies, having received at least 6 months of treatment. They should benefit from continued use and agree to contraception. Excluded are those needing strong CYP3A4/5 inhibitors or anticoagulants like warfarin.Check my eligibility
What is being tested?
The study aims to collect long-term data on the safety and effectiveness of the drug Ibrutinib for various lymphomas, leukemias, and graft-versus-host disease. It provides ongoing access to Ibrutinib for eligible participants.See study design
What are the potential side effects?
Ibrutinib may cause side effects such as bleeding problems, infections, fatigue, diarrhea, muscle and bone pain. The risk varies by individual health conditions.
CAN3001 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been in an ibrutinib study for over 6 months.
CAN3001 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier
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 affected by an adverse event
Secondary outcome measures
Number of participants with change in disease status
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%
Stomatitis
5%
Actinic keratosis
5%
Gingival bleeding
5%
Rhinorrhoea
5%
Dermatitis
5%
Onychomycosis
5%
Mouth ulceration
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%
Vertigo
4%
Haemorrhoids
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%
Bladder transitional cell carcinoma
3%
Rotator cuff syndrome
3%
Dysuria
3%
Pollakiuria
3%
Abdominal distension
3%
Dry eye
3%
Inguinal hernia
3%
Hypoalbuminaemia
3%
Tinnitus
3%
Osteoporosis
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%
Viral infection
1%
Haemolytic anaemia
1%
Haemorrhagic disorder
1%
Wound infection staphylococcal
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
CAN3001 Trial Design
1Treatment groups
Experimental Treatment
Group I: IbrutinibExperimental Treatment1 Intervention
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.Industry Sponsor
113 Previous Clinical Trials
13,120 Total Patients Enrolled
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,608 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,205 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need blood thinners like warfarin.My doctor believes the benefits of my current cancer treatment outweigh the risks.I need treatment with specific strong medications, approved by the trial sponsor.I am currently being treated with ibrutinib alone or with nivolumab, or I am in a specific ibrutinib study.I have been in an ibrutinib study for over 6 months.You must have a negative pregnancy test before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Ibrutinib
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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 some other examples of research that has been conducted using Ibrutinib?
"Ibrutinib was first studied in 2011 at the National Institutes of Health Clinical Center. 97 clinical trials have been completed since then, with 158 more active studies presently underway. A high volume of these investigations are taking place in Marietta, Georgia."
Answered by AI
Can new patients still join this clinical trial?
"This particular study is not recruiting patients at the moment. It was first posted on September 9th, 2013 with the most recent update being November 3rd, 2022. However, there are 2413 other clinical trials related to waldenstrom macroglobulinemia and 158 studies involving Ibrutinib that are actively seeking participants."
Answered by AI
Is this clinical trial happening in more than one state?
"This study has 30 active locations, which are hospitals and cancer institutes including Northwest Georgia Oncology Centers PC in Marietta, The Ohio State University- James Cancer Hospital in Columbus, and Karmanos Cancer Institute - Wayne State University in Detroit."
Answered by AI
Has the FDA okayed ibrutinib for public use?
"This medication has been through multiple rounds of testing and has shown efficacy in some cases, so it is considered safe and was given a score of 3."
Answered by AI
How many individuals are involved in this clinical trial?
"This particular study has completed recruitment and is no longer looking for patients. The trial was originally posted on September 9th, 2013 but the most recent edit was on November 3rd, 2020. For those still seeking studies, there are 2413 trials actively recruiting patients with waldenstrom macroglobulinemia and 158 studies for Ibrutinib that have open enrolment."
Answered by AI
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