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Monoclonal Antibodies
ibrutinib for Chronic Lymphocytic Leukemia
Phase 1 & 2
Waitlist Available
Led By Thomas E Kipps, MD, PhD
Research Sponsored by University of California, San Diego
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 2 years
Awards & highlights
Study Summary
This trial will test if ibrutinib, when combined with GA101-obinutuzumab, can help treat CLL by reducing the amount of cancerous cells in the body.
Eligible Conditions
- Chronic Lymphocytic Leukemia
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
Phase IB Evaluate the safety, tolerability and dose limiting toxicity (DLT) of Ibrutinib in combination with Obinutuzumab in previously untreated CLL subjects.
Phase II Determine the overall response rate of Ibrutinib in combination with Obinutuzumab in previously untreated subjects with CLL.
Secondary outcome measures
Determine progression-free survival (PFS), treatment-free survival (TFS) and overall survival (OS) in previously untreated CLL subjects that will receive treatment with Ibrutinib in combination with Obinutuzumab.
Negative minimal residual disease (MRDneg)
Side 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%
Muscle Strain
1%
Bronchitis
1%
Conjunctivitis
1%
Sepsis Syndrome
1%
Pulmonary Mass
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: GA101+ibrutinibExperimental Treatment2 Interventions
Ibrutinib 420 mg (140 mg capsules 3 times) orally once daily for up to 6 cycles.
GA101 (Obinutuzumab) by Intravenous infusion for up to 6 cycles (28 day cycles) as follows:
Cycle 1, Day 1,100 mg GA101 obinutuzumab will be administered.
Cycle 1, Day 2, 900 mg of GA101 obinutuzumab will be administered.
Cycle 1, Days 8 and 15,1,000 mg of GA101 obinutuzumab will be administered.
Cycles 2-6, Day 1, 1,000 mg of GA101 obinutuzumab will be administered.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ibrutinib
2012
Completed Phase 3
~1390
GA101
2015
Completed Phase 2
~250
Find a Location
Who is running the clinical trial?
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,788 Total Patients Enrolled
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,375 Total Patients Enrolled
Thomas E Kipps, MD, PhDPrincipal InvestigatorUniversity of California, San Diego
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious lung disease that makes it difficult to breathe or function normally.You have experienced severe allergic reactions to similar types of medication in the past.You are allergic to any of the study drugs.You are taking warfarin or other medications that affect Vitamin K.You have said that you do not want to receive chemotherapy treatment.You are expected to live for at least 6 more months.You cannot be receiving chemotherapy, monoclonal antibodies, or certain other medications while participating in this trial.You have severe heart disease, classified as New York Heart Association Functional Class 3 or 4.
Research Study Groups:
This trial has the following groups:- Group 1: GA101+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.
Are there still openings for volunteers to join this research project?
"Contrary to expectations, this clinical trial is not currently looking for study participants. Initially posted on November 1st 2015 and last edited July 1st 2022, the investigation has been paused at present; nevertheless there are 1759 alternative medical studies that are presently enrolling patients."
Answered by AI
How many participants have been recruited for this experiment?
"Unfortunately, this medical investigation is not actively seeking participants at the moment. It was initially published on November 1st 2015 and last revised July 1st 2022; however, alternative trials with leukemia-related cases are currently enrolling patients (1522) while 237 studies have opened recruitment for ibrutinib treatments."
Answered by AI
To what illnesses is ibrutinib typically employed as a remedy?
"Ibrutinib is a common treatment for lymphoid leukemia and can be effective in managing waldenstrom macroglobulinemia, refractory follicular lymphoma, or chronic lymphocytic leukemia (CLL)."
Answered by AI
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