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Chemotherapy
Ibrutinib for Chronic Lymphocytic Leukemia
Phase 3
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
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
Study Summary
This trial is for people with CLL or SLL who are 65 or older. The trial compares the effects of ibrutinib to chlorambucil.
Eligible Conditions
- Chronic Lymphocytic Leukemia
- Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy evaluation of subsequent therapy
Long-term follow-up and Second-line therapy monitoring
Progression-free Survival (PFS)
+1 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%
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%
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%
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%
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%
Tinnitus
3%
Abdominal distension
3%
Dysuria
3%
Pollakiuria
3%
Dry eye
3%
Osteoporosis
3%
Erythema
3%
Bladder transitional cell carcinoma
3%
Hypoalbuminaemia
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%
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
4Treatment groups
Experimental Treatment
Group I: Arm D Alternative Anticancer TherapyExperimental Treatment1 Intervention
At the Investigator's discretion, alternative anticancer treatment is a therapeutic option for patients who experienced PD during Ibrutinib treatment or during or after Chlorambucil treatment. This Arm can also be considered if drug is discontinued for other reasons (e.g., intolerability or adverse event [AE]) or prior to experiencing PD).
Group II: Arm C Second-line IbrutinibExperimental Treatment2 Interventions
Patients who received Chlorambucil in the parent study (PCYC-1115-CA) and experienced PD are transferred to this Arm for Ibrutinib treatment. Treatment will continue until PD, unacceptable toxicity, or other reasons for treatment discontinuation.
Group III: Arm B IbrutinibExperimental Treatment2 Interventions
Patients randomized to Ibrutinib in the parent study (PCYC-1115-CA) who have not experienced PD at the time of parent study closure will be transferred to this Arm to continue on Ibrutinib treatment. Treatment will continue until PD, unacceptable toxicity, or other reasons for treatment discontinuation.
Group IV: Arm A Post-Chlorambucil Therapy FollowupExperimental Treatment2 Interventions
Patients randomized to Chlorambucil in the parent study(PCYC-1115-CA) who have not progressed at the time of parent study closure will be transferred to this Arm. Follow-up will continue until PD, unacceptable toxicity, or other reason for treatment discontinuation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Post-Chlorambucil Therapy Follow-up
2012
Completed Phase 3
~240
Ibrutinib
2014
Completed Phase 3
~1880
Alternative Anticancer Treatment
2012
Completed Phase 3
~240
Alternative Anti-cancer Treatment
2012
Completed Phase 3
~240
Second-line Ibrutinib
2012
Completed Phase 3
~240
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCIndustry Sponsor
975 Previous Clinical Trials
6,384,128 Total Patients Enrolled
Pharmacyclics LLC.Lead Sponsor
113 Previous Clinical Trials
13,583 Total Patients Enrolled
Jim Dean, MD, PhDStudy DirectorPharmacyclics LLC.
1 Previous Clinical Trials
323 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the most popular conditions that ibrutinib is used to treat?
"Ibrutinib is often used to treat mantle cell lymphoma (mcl), indolent lymphoma, and malt lymphoma in addition to other forms of cancerous lymphoma."
Answered by AI
How many individuals are currently participating in this research?
"Though this trial was posted on 8/28/2012 and updated as recently as 7/15/2022, it is not currently looking for candidates. There are 2950 trials for leukemia and 164 trials for Ibrutinib that may have open recruitment at this time."
Answered by AI
Does ibrutinib have a history of being studied in other scientific research trials?
"Ibrutinib was first studied in the year 2011 at National Institutes of Health Clinical Center, 9000 Rockville Pike. 118 clinical trials have completed since then with 164 more presently underway. A large number of these studies are based out of Seattle, Washington."
Answered by AI
What are the most common side effects associated with Ibrutinib?
"Ibrutinib has received a score of 3 from our analysts at Power. This is due to the fact that Ibrutinib is in Phase 3 trials, which suggests that not only does this drug have some efficacy, but also that there is extensive safety data available."
Answered by AI
Are there many places in the city where this test is being conducted?
"This study is currently recruiting patients from 24 sites across the country. The locations of the sites are listed on the website, and it is encouraged that patients choose the location closest to them to minimize travel demands."
Answered by AI
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