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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 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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2018 Phase 3 trial • 391 Patients • NCT01578707
34%
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
13,813 Total Patients Enrolled
University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,575,015 Total Patients Enrolled
Thomas E Kipps, MD, PhDPrincipal InvestigatorUniversity of California, San Diego

Media Library

GA101 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02315768 — Phase 1 & 2
Chronic Lymphocytic Leukemia Research Study Groups: GA101+ibrutinib
Chronic Lymphocytic Leukemia Clinical Trial 2023: GA101 Highlights & Side Effects. Trial Name: NCT02315768 — Phase 1 & 2
GA101 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02315768 — Phase 1 & 2
~3 spots leftby Nov 2025
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