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Bruton's Tyrosine Kinase (BTK) Inhibitor
Ibrutinib for Chronic Lymphocytic Leukemia
Phase 2
Waitlist Available
Led By Philip A. Thompson, MBBS
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of CLL/SLL that meets IWCLL diagnostic criteria
Adequate hepatic and renal function as indicated by specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is for people with CLL or SLL who have not yet started treatment. Ibrutinib will be given to see if it is more effective than the current standard of care, which is to wait for symptoms to develop before starting treatment.
Who is the study for?
This trial is for adults diagnosed with CLL/SLL who meet specific criteria, have not yet shown symptoms, and are expected to need treatment within 3 years. Participants must be able to perform daily activities (ECOG status 0-2) and use effective birth control methods. They should not have other serious health issues or a history of certain conditions like stroke or uncontrolled bleeding.Check my eligibility
What is being tested?
The study tests if taking Ibrutinib early in symptom-free patients with CLL/SLL can be more effective than waiting for symptoms to appear. Ibrutinib is approved for treating these cancers but using it before symptoms show up is investigational. All participants will receive the drug at MD Anderson Cancer Center.See study design
What are the potential side effects?
While the description doesn't list side effects, common ones associated with Ibrutinib include diarrhea, bleeding problems, high blood pressure, infections, fatigue, fever, bone marrow suppression leading to low blood cell counts which increases infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with CLL or SLL.
Select...
My liver and kidney functions are within normal ranges.
Select...
I am 18 or older, understand and agree to the study's consent, and can follow the study's procedures.
Select...
I don't meet the treatment criteria for my leukemia.
Select...
I am able to care for myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Remission (CR) with Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL)
Complete Remission with Incomplete Count Recovery (CRi) with Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL)
Secondary outcome measures
Overall response rate (ORR) of Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL)
Progression-Free Survival (PFS) with Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL)
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
Participants take Ibrutinib by mouth 1 time every day for up to 2 years (24 cycles).
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?
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,479 Total Patients Enrolled
452 Trials studying Leukemia
31,511 Patients Enrolled for Leukemia
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,786 Total Patients Enrolled
31 Trials studying Leukemia
5,277 Patients Enrolled for Leukemia
Philip A. Thompson, MBBSPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
9 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious wound or fracture that is not healing.I currently have an infection that isn't under control.I have been diagnosed with CLL or SLL.I have not had major surgery recently.I have not received any live vaccines in the last 4 weeks.I have a history of HIV, or I am currently infected with hepatitis B or C.I am not taking strong CYP3A4 inhibitors or inducers.I have CLL and may have had prior treatment under certain conditions.My liver and kidney functions are within normal ranges.My condition has progressed to Richter's Syndrome.I am 18 or older, understand and agree to the study's consent, and can follow the study's procedures.I don't meet the treatment criteria for my leukemia.I agree to use two forms of birth control during and after the treatment.I do not have any severe illnesses or serious organ problems.I am receiving treatment for cancer, not including CLL, unless specified otherwise.I have an active autoimmune blood disorder needing daily prednisone of 20 mg or more.I do not have any ongoing serious infections.I have a heart condition that affects my daily life.I have not had bleeding or clotting problems in the last 3 months.I have had a bleeding event in my brain that caused symptoms.I had a stroke caused by a blood clot in the past 6 months.I have been cancer-free for the last 3 years, with some exceptions.I am able to care for myself and perform daily activities.I am on blood thinners like warfarin.I have severe liver problems.
Research Study Groups:
This trial has the following groups:- Group 1: Ibrutinib
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.
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