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Bruton's Tyrosine Kinase (BTK) Inhibitor

Ibrutinib + Rituximab for Follicular Lymphoma

Phase 3
Waitlist Available
Research Sponsored by Pharmacyclics LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status score of 0-2
Measurable disease
Must not have
Prior treatment for follicular lymphoma
Central nervous system lymphoma or leptomeningeal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-5 years
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial

Summary

This trial will compare ibrutinib + rituximab vs rituximab alone in people with untreated follicular lymphoma. The goal is to see if ibrutinib helps people live longer without the cancer progressing.

Who is the study for?
This trial is for adults aged 60 and older with untreated follicular lymphoma, who meet specific health criteria. They should have a certain level of physical fitness (ECOG score 0-2) and their liver and kidneys must work well. People with transformed lymphoma, brain or spinal cord lymphoma, serious heart conditions, or previous treatments for this cancer can't join.
What is being tested?
The study tests if adding Ibrutinib to Rituximab therapy extends the time patients live without their cancer getting worse compared to using Rituximab alone. Participants will either receive Ibrutinib plus Rituximab or a placebo (inactive substance) plus Rituximab.
What are the potential side effects?
Ibrutinib may cause diarrhea, bleeding problems, infections, fatigue, muscle and bone pain. Rituximab can lead to infusion reactions like fever and chills; it might also increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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My cancer can be measured by tests.
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My lymphoma is confirmed to be a type that affects the immune system and is at an advanced stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received treatment for follicular lymphoma before.
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My cancer affects my brain or spinal cord.
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I have a serious heart condition that is currently causing symptoms.
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My lymphoma has changed into a more aggressive form.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with Progression-Free Survival (PFS)
Secondary study objectives
Duration of Response (DOR) as Assessed by Investigator
Infusion-Related Reaction Rate
Number of Participants with Adverse Events (AE)
+2 more

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

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: (Arm A) ibrutinib + rituximabExperimental Treatment2 Interventions
Participants will receive 560mg of ibrutinib and rituximab 375mg/m\^2 weekly x4 with maintenance.
Group II: (Arm B) placebo + rituximabPlacebo Group2 Interventions
Participants will receive placebo and rituximab 375mg/m\^2 weekly x4 with maintenance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
Ibrutinib
FDA approved

Find a Location

Who is running the clinical trial?

Pharmacyclics LLC.Lead Sponsor
113 Previous Clinical Trials
13,404 Total Patients Enrolled

Media Library

Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02947347 — Phase 3
Follicular Lymphoma Research Study Groups: (Arm A) ibrutinib + rituximab, (Arm B) placebo + rituximab
Follicular Lymphoma Clinical Trial 2023: Ibrutinib Highlights & Side Effects. Trial Name: NCT02947347 — Phase 3
Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02947347 — Phase 3
~50 spots leftby Dec 2025
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