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Bruton's Tyrosine Kinase Inhibitor
Ibrutinib for Chronic Lymphocytic Leukemia
Phase 2
Waitlist Available
Research Sponsored by Kami Maddocks, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is testing a new drug for people with relapsed/refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, or prolymphocytic leukemia.
Who is the study for?
This trial is for adults with relapsed or refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia who have failed at least one prior therapy. They should be in relatively stable condition (ECOG <=2), have a life expectancy over 2 months, and normal organ function as defined by specific blood test levels.Check my eligibility
What is being tested?
The study tests the effectiveness of Ibrutinib (PCI-32765) on its own in patients with certain types of leukemia and lymphoma that haven't responded to previous treatments. It's an open-label Phase II trial where everyone gets the drug; there's no comparison group.See study design
What are the potential side effects?
Ibrutinib may cause side effects like diarrhea, bleeding problems, high blood pressure, fatigue, muscle and bone pain. Some people might also experience infections due to lowered white blood cell counts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the 2 Year Progression-free Survival (PFS) of Single Agent PCI-32765 in Patients With Relapsed and Refractory CLL.
Secondary outcome measures
2-year Kaplan-Meier Estimate of OS for Relapsed and Refractory CLL Patients Treated With Single Agent PCI-32765
Best Overall Response Rate Using the Revised International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Working Group Guidelines
Cancer-Specific Stress as Measured by the Impact of Event Scale-Revised (IES-R)
+12 moreSide effects data
From 2018 Phase 3 trial • 391 Patients • NCT0157870734%
Infusion Related Reaction
30%
Fatigue
23%
Cough
20%
Nausea
17%
Diarrhoea
17%
Anaemia
14%
Pyrexia
14%
Peripheral Sensory Neuropathy
13%
Neutropenia
12%
Night Sweats
12%
Thrombocytopenia
10%
Abdominal Pain
10%
Constipation
9%
Upper Respiratory Tract Infection
9%
Pruritus
9%
Dyspnoea
8%
Oedema Peripheral
8%
Decreased Appetite
8%
Insomnia
8%
Muscle Spasms
7%
Arthralgia
7%
Back Pain
6%
Sinusitis
6%
Vomiting
6%
Pneumonia
6%
Weight Decreased
6%
Headache
5%
Dry Eye
5%
Oropharyngeal pain
5%
Anxiety
5%
Pain in Extremity
5%
Musculoskeletal Pain
5%
Rash Erythematous
5%
Urinary Tract Infection
5%
Dizziness
5%
Paraesthesia
4%
Myalgia
4%
Asthenia
4%
Nasopharyngitis
4%
Rash Maculo-Papular
4%
Rash
3%
Dyspepsia
3%
Vision Blurred
3%
Rhinorrhoea
3%
Stomatitis
3%
Hyperglycaemia
3%
Lacrimation Increased
3%
Chills
3%
Hypokalaemia
3%
Contusion
3%
Eye Pain
3%
Influenza Like Illness
3%
Nasal Congestion
3%
Productive Cough
3%
Skin Lesion
3%
Actinic Keratosis
3%
Lymphocytosis
3%
Epistaxis
2%
Cellulitis
2%
Bone Pain
2%
Chronic Lymphocytic Leukaemia
2%
Febrile Neutropenia
2%
Vitreous Floaters
2%
Abdominal Pain Upper
2%
Herpes Zoster
2%
Hyponatraemia
2%
Confusional State
2%
Haemorrhoids
2%
Muscular Weakness
2%
Gastrooesophageal Reflux Disease
2%
Depression
2%
Pollakiuria
2%
Increased Tendency to Bruise
2%
Photophobia
2%
Dyspnoea Exertional
2%
Dry Skin
2%
Hypertension
2%
Hyperuricaemia
2%
Eye Irritation
1%
Anal Infection
1%
Herpes Simplex
1%
Febrile Infection
1%
Renal Impairment
1%
Bronchitis
1%
Conjunctivitis
1%
Sepsis Syndrome
1%
Pulmonary Mass
1%
Muscle Strain
1%
Sepsis
1%
Pneumonia Pseudomonal
1%
Stenotrophomonas Infection
1%
Cardiac Failure
1%
Malabsorption
1%
Bacteraemia
1%
Autoimmune Haemolytic Anaemia
1%
Neutropenic Sepsis
1%
Sinus Tachycardia
1%
Breast Cellulitis
1%
Pseudomonas Infection
1%
Respiratory Tract Infection
1%
Pneumocystis Jirovecii Ppneumonia
1%
Abscess Limb
1%
Infectious Pleural Effusion
1%
Influenza
1%
Ear Infection
1%
Tumour Lysis Syndrome
1%
Multiple Fractures
1%
Haemoptysis
1%
Flatulence
1%
Spinal Compression Fracture
1%
Deep Vein Thrombosis
1%
Squamous Cell Carcinoma
1%
Metastatic Squamous Cell Carcinoma
1%
Fall
1%
Haemolytic Anaemia
1%
Methaemoglobinaemia
1%
Atrial Fibrillation
1%
Myocardial infarction
1%
Acute myocardial infarction
1%
Folliculitis
1%
Major Depression
1%
Acute Kidney Injury
1%
Renal Failure
1%
Pneumonitis
1%
Pulmonary Embolism
1%
Cataract
1%
Visual Acuity Reduced
1%
Malaise
1%
Basal Cell Carcinoma
1%
Haematuria
1%
Blood Blister
1%
Lower Respiratory Tract Infection
1%
Infection
1%
Pneumonia Bacterial
1%
Respiratory Tract Inflammation
1%
Supraventricular Tachycardia
1%
Petechiae
1%
Septic Shock
1%
Effusion
1%
Anaphylactic Shock
1%
Lung Infection Pseudomonal
1%
Nocardiosis
1%
Ophthalmic Herpes Zoster
1%
Pneumonia Mycoplasmal
1%
Tumour Pain
1%
Dry Mouth
1%
Dysuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ofatumumab (Arm A)
Ibrutinib (Arm B)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ibrutinib)Experimental Treatment3 Interventions
Patients will be treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ibrutinib
2012
Completed Phase 3
~1390
Find a Location
Who is running the clinical trial?
Kami Maddocks, MDLead Sponsor
2 Previous Clinical Trials
66 Total Patients Enrolled
Kami MaddocksLead Sponsor
3 Previous Clinical Trials
68 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is ibrutinib more likely to create adverse reactions in patients?
"While there is some data supporting ibrutinib's safety, it remains unproven whether the medication is actually effective. Consequently, it received a score of 2."
Answered by AI
How many people are participating in this research?
"As of right now, this study has completed recruitment for their clinical trial. This particular trial was initially posted on May 21st, 2012 and most recently updated on June 27th, 2022. If you are looking for other studies to participate in, there are 2950 trials actively admitting patients with chronic lymphocytic leukemia and 202 ibrutinib studies recruiting patients."
Answered by AI
Are new participants currently being enrolled in this clinical trial?
"Unfortunately, this particular trial is not accepting candidates at the moment. It was initially posted on May 21st, 2012 and last updated June 27th, 2022. If you're interested in other leukemia trials, there are 2950 clinical studies currently recruiting for chronic lymphocytic leukemia and 202 ibrutinib trials with open enrollment."
Answered by AI
For what reasons is ibrutinib generally given to patients?
"Ibrutinib is commonly used to supplement amino acid therapy. However, it has also been shown to help patients with renal dysfunction, chronic lymphocytic leukemia (CLL), and kidney failure."
Answered by AI
Have these medical procedures been tested before on humans?
"Ibrutinib has been under research since 2007 when the first trial, sponsored by Baxter Healthcare Corporation, was conducted. In total there have been 4640 participants in ibrutinib trials. The most recent stage of drug approval, Phase 4, was received in 2007. As of now, 202 active studies are being conducted for ibrutinib across 44 countries and 1482 cities"
Answered by AI
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