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Monoclonal Antibodies
Ibrutinib in Combination With GA101 (Obinutuzumab) in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Patients.
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 up to 5 years
Awards & highlights
No Placebo-Only Group
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 ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side 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: 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
GA101
2015
Completed Phase 2
~250
ibrutinib
2012
Completed Phase 3
~1390
Find a Location
Who is running the clinical trial?
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,821 Total Patients Enrolled
University of California, San DiegoLead Sponsor
1,187 Previous Clinical Trials
1,576,743 Total Patients Enrolled
Thomas E Kipps, MD, PhDPrincipal InvestigatorUniversity of California, San Diego
Thomas J. 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.