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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
No Placebo-Only Group
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Determine the 2 Year Progression-free Survival (PFS) of Single Agent PCI-32765 in Patients With Relapsed and Refractory CLL.
Secondary study objectives
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)
+11 moreSide effects data
From 2018 Phase 3 trial • 391 Patients • NCT0157870734%
Infusion Related Reaction
30%
Fatigue
23%
Cough
20%
Nausea
17%
Anaemia
17%
Diarrhoea
14%
Pyrexia
14%
Peripheral Sensory Neuropathy
13%
Neutropenia
12%
Thrombocytopenia
12%
Night Sweats
10%
Constipation
10%
Abdominal Pain
9%
Upper Respiratory Tract Infection
9%
Dyspnoea
9%
Pruritus
8%
Insomnia
8%
Oedema Peripheral
8%
Decreased Appetite
8%
Muscle Spasms
7%
Arthralgia
7%
Back Pain
6%
Pneumonia
6%
Vomiting
6%
Sinusitis
6%
Weight Decreased
6%
Headache
5%
Anxiety
5%
Dry Eye
5%
Pain in Extremity
5%
Musculoskeletal Pain
5%
Oropharyngeal pain
5%
Rash Erythematous
5%
Urinary Tract Infection
5%
Dizziness
5%
Paraesthesia
4%
Asthenia
4%
Nasopharyngitis
4%
Myalgia
4%
Rash Maculo-Papular
4%
Rash
3%
Lacrimation Increased
3%
Lymphocytosis
3%
Vision Blurred
3%
Eye Pain
3%
Stomatitis
3%
Dyspepsia
3%
Chills
3%
Influenza Like Illness
3%
Contusion
3%
Hypokalaemia
3%
Hyperglycaemia
3%
Epistaxis
3%
Rhinorrhoea
3%
Nasal Congestion
3%
Productive Cough
3%
Skin Lesion
3%
Actinic Keratosis
2%
Depression
2%
Confusional State
2%
Pollakiuria
2%
Febrile Neutropenia
2%
Chronic Lymphocytic Leukaemia
2%
Increased Tendency to Bruise
2%
Eye Irritation
2%
Photophobia
2%
Vitreous Floaters
2%
Gastrooesophageal Reflux Disease
2%
Abdominal Pain Upper
2%
Haemorrhoids
2%
Cellulitis
2%
Herpes Zoster
2%
Hyperuricaemia
2%
Hyponatraemia
2%
Bone Pain
2%
Muscular Weakness
2%
Dyspnoea Exertional
2%
Dry Skin
2%
Hypertension
1%
Cataract
1%
Haematuria
1%
Spinal Compression Fracture
1%
Autoimmune Haemolytic Anaemia
1%
Acute myocardial infarction
1%
Sinus Tachycardia
1%
Haemolytic Anaemia
1%
Myocardial infarction
1%
Methaemoglobinaemia
1%
Cardiac Failure
1%
Atrial Fibrillation
1%
Supraventricular Tachycardia
1%
Malabsorption
1%
Sepsis
1%
Bacteraemia
1%
Lower Respiratory Tract Infection
1%
Infection
1%
Bronchitis
1%
Pneumocystis Jirovecii Ppneumonia
1%
Influenza
1%
Neutropenic Sepsis
1%
Pneumonia Pseudomonal
1%
Folliculitis
1%
Pseudomonas Infection
1%
Respiratory Tract Infection
1%
Pneumonia Bacterial
1%
Febrile Infection
1%
Abscess Limb
1%
Anal Infection
1%
Breast Cellulitis
1%
Herpes Simplex
1%
Infectious Pleural Effusion
1%
Sepsis Syndrome
1%
Stenotrophomonas Infection
1%
Multiple Fractures
1%
Muscle Strain
1%
Tumour Lysis Syndrome
1%
Squamous Cell Carcinoma
1%
Metastatic Squamous Cell Carcinoma
1%
Major Depression
1%
Acute Kidney Injury
1%
Renal Failure
1%
Renal Impairment
1%
Haemoptysis
1%
Pneumonitis
1%
Pulmonary Embolism
1%
Pulmonary Mass
1%
Respiratory Tract Inflammation
1%
Deep Vein Thrombosis
1%
Visual Acuity Reduced
1%
Flatulence
1%
Malaise
1%
Conjunctivitis
1%
Ear Infection
1%
Fall
1%
Basal Cell Carcinoma
1%
Petechiae
1%
Blood Blister
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)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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