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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My cancer can be measured by tests.
Select...
My lymphoma is confirmed to be a type that affects the immune system and is at an advanced stage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Progression-Free Survival (PFS)
Secondary outcome measures
Duration of Response (DOR) as Assessed by Investigator
Infusion-Related Reaction Rate
Number of Participants with Adverse Events (AE)
+2 moreSide 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%
Pulmonary Mass
1%
Renal Impairment
1%
Sepsis Syndrome
1%
Bronchitis
1%
Conjunctivitis
1%
Muscle Strain
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
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
13,375 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver and kidney functions are within normal ranges.I have a serious heart condition that is currently causing symptoms.My cancer can be measured by tests.I am 70 or older, or I am 60-69 with one or more health conditions.I can take care of myself and am up and about more than half of my waking hours.I have received treatment for follicular lymphoma before.My cancer affects my brain or spinal cord.My lymphoma is confirmed to be a type that affects the immune system and is at an advanced stage.My blood test results are within the required range.My lymphoma has changed into a more aggressive form.
Research Study Groups:
This trial has the following groups:- Group 1: (Arm A) ibrutinib + rituximab
- Group 2: (Arm B) placebo + rituximab
Awards:
This trial has 2 awards, including:- 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.
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.
Has ibrutinib received the green light from the FDA?
"ibrutinib has received a score of 3 from our analysts at Power. This is based on the fact that ibrutinib is a Phase 3 trial, meaning that there is existing data which supports its efficacy as well as multiple rounds of data affirming its safety."
Answered by AI
At how many different hospitals is this trial being conducted?
"There are a total of 39 clinical trial sites currently operational. A few notable locations include MD Anderson Cancer Center in Houston, Medical Oncology Associates in Spokane, and Goldschmidt Cancer Center in Jefferson City."
Answered by AI
What is the scientific community's opinion of ibrutinib?
"The drug ibrutinib was first trialed in 1993 at the National Institutes of Health Clinical Center. Since then, 886 clinical trials have been completed with 542 still active. Many of these active trials are based in Houston, Texas."
Answered by AI
How many people can be enrolled in this trial at one time?
"No, this study has already completed recruitment for patients. The trial was posted on 1/1/2017 and was last updated on 9/8/2022. However, there are other ongoing trials that might be of interest. Presently, there are 1751 clinical trials actively admitting participants with lymphoma and 542 trials for ibrutinib enrolling patients."
Answered by AI
Are there any vacancies in this research program for test subjects?
"At this moment in time, this clinical trial is not seeking new patients. However, this could change in the future as the trial was last edited on September 8th, 2022. If you are interested in participating in similar trials, there are presently 1751 clinical trials actively enrolling patients with lymphoma and 542 trials for ibrutinib actively recruiting patients."
Answered by AI
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