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Alkylating agents
Ibrutinib + Chemotherapy for Mantle Cell Lymphoma
Phase 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical Stage II, III, or IV by Ann Arbor Classification
At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 97 months
Awards & highlights
Study Summary
This trial will test ibrutinib given with bendamustine and rituximab to see if it is effective and safe in treating mantle cell lymphoma in patients over 65.
Who is the study for?
This trial is for people 65 or older newly diagnosed with mantle cell lymphoma, which is a type of cancer affecting white blood cells. Participants must have certain lab-confirmed markers, measurable disease, no prior MCL treatments, good physical function (ECOG grade 0 or 1), and acceptable blood test results. They can't join if they've had major surgery recently, CNS lymphoma, serious heart issues within the past six months, HIV/Hepatitis B/C infections requiring IV antibiotics, another active malignancy except in specific cases or a stroke/hemorrhage recently.Check my eligibility
What is being tested?
The study tests how well Ibrutinib works alongside Bendamustine and Rituximab to treat mantle cell lymphoma in patients who haven't been treated before. Some participants will receive Ibrutinib while others may get a placebo as part of the study's design to compare outcomes.See study design
What are the potential side effects?
Ibrutinib might cause bleeding problems, high blood pressure, irregular heartbeat among other side effects. Bendamustine can lead to low blood counts increasing infection risk and may also cause allergic reactions. Rituximab could potentially cause infusion-related reactions and infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is at stage II, III, or IV according to the Ann Arbor system.
Select...
I have at least one tumor that can be measured.
Select...
I have not received any treatments for mantle cell lymphoma.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My lymphoma diagnosis was confirmed with specific tests for cyclin D1 and other markers, or the t(11;14) genetic change.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 97 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 97 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival (PFS)
Secondary outcome measures
Area Under the Concentration Curve of Ibrutinib During 24 Hours After Dosing at Steady State
Complete Response Rate
Duration of Complete Response (DoCR)
+12 moreSide effects data
From 2022 Phase 3 trial • 201 Patients • NCT0305344037%
Diarrhoea
32%
Upper respiratory tract infection
29%
Muscle spasms
28%
Contusion
24%
Arthralgia
24%
Hypertension
22%
Oedema peripheral
22%
Anaemia
21%
Epistaxis
20%
Cough
19%
Rash
19%
Fatigue
18%
Back pain
18%
Atrial fibrillation
17%
Urinary tract infection
16%
Neutropenia
16%
Thrombocytopenia
15%
Nausea
15%
Headache
15%
Vomiting
14%
Pneumonia
14%
Dizziness
13%
Haematuria
12%
Peripheral swelling
12%
Pyrexia
12%
Constipation
11%
Localised infection
10%
Onychoclasis
10%
Pain in extremity
10%
Fall
10%
Oropharyngeal pain
10%
Lower respiratory tract infection
10%
Sinusitis
10%
Palpitations
9%
Nasopharyngitis
9%
Hyperuricaemia
9%
Insomnia
9%
Dyspnoea
9%
Haematoma
8%
Skin laceration
8%
Paraesthesia
7%
Dry skin
7%
Dyspepsia
7%
Cellulitis
7%
Conjunctivitis
7%
Skin infection
7%
Iron deficiency
7%
Anxiety
7%
Rhinitis
6%
Cataract
6%
Conjunctival haemorrhage
6%
Pruritus
6%
Hypokalaemia
6%
Syncope
6%
Vision blurred
6%
Abdominal pain
6%
Abdominal pain upper
6%
Nail infection
6%
Neck pain
6%
Purpura
6%
Asthenia
5%
Stomatitis
5%
Actinic keratosis
5%
Gingival bleeding
5%
Rhinorrhoea
5%
Dermatitis
5%
Onychomycosis
5%
Mouth ulceration
5%
Petechiae
5%
Abdominal discomfort
5%
Chest pain
5%
Influenza like illness
5%
COVID-19
5%
Gastroenteritis
5%
Tooth infection
5%
Limb injury
5%
Squamous cell carcinoma of skin
5%
Peripheral sensory neuropathy
5%
Rosacea
5%
Increased tendency to bruise
5%
Gout
5%
Basal cell carcinoma
5%
Folliculitis
5%
Oral herpes
5%
Gastrooesophageal reflux disease
4%
Haemorrhoids
4%
Vertigo
4%
Ecchymosis
4%
Sepsis
4%
Angina pectoris
4%
Retinal haemorrhage
4%
Dry mouth
4%
Chills
4%
Bronchitis
4%
Furuncle
4%
Joint injury
4%
Blood alkaline phosphatase increased
4%
Neutrophil count decreased
4%
Decreased appetite
4%
Joint swelling
4%
Depression
4%
Productive cough
4%
Skin ulcer
4%
Atrial flutter
4%
Hyperglycaemia
4%
Herpes zoster
3%
Abdominal distension
3%
Rotator cuff syndrome
3%
Dysuria
3%
Pollakiuria
3%
Dry eye
3%
Bladder transitional cell carcinoma
3%
Inguinal hernia
3%
Hypoalbuminaemia
3%
Tinnitus
3%
Osteoporosis
3%
Erythema
3%
Acute myocardial infarction
3%
Sinus bradycardia
3%
Dysphagia
3%
Malaise
3%
Cystitis
3%
Alanine aminotransferase increased
3%
Gamma-glutamyltransferase increased
3%
Musculoskeletal chest pain
3%
Seborrhoeic keratosis
3%
Neuralgia
3%
Benign prostatic hyperplasia
3%
Dyspnoea exertional
3%
Nasal congestion
3%
Pneumonitis
3%
Psoriasis
3%
Skin fissures
3%
Skin lesion
3%
Laryngitis
3%
Respiratory tract infection
3%
Bradycardia
3%
Acute kidney injury
3%
Wound infection
3%
Myalgia
3%
Skin toxicity
3%
Ear infection
3%
Paronychia
3%
Osteoarthritis
3%
Pericarditis
3%
Sciatica
3%
Ocular hyperaemia
3%
Nail disorder
2%
Rectal haemorrhage
2%
Cholecystitis
2%
COVID-19 pneumonia
2%
Pleural effusion
2%
Drug withdrawal syndrome
2%
Seasonal allergy
2%
Vitamin D deficiency
2%
Rash maculo-papular
2%
Hypotension
2%
Death
2%
Loss of consciousness
1%
Wheezing
1%
Viral infection
1%
Haemolytic anaemia
1%
Haemorrhagic disorder
1%
Wound infection staphylococcal
1%
Cardiac failure acute
1%
Colitis
1%
Oral blood blister
1%
Upper gastrointestinal haemorrhage
1%
Drug-induced liver injury
1%
Bacterial sepsis
1%
Brain abscess
1%
Device related infection
1%
Gastrointestinal infection
1%
Neurocryptococcosis
1%
Septic shock
1%
Streptococcal bacteraemia
1%
Femoral neck fracture
1%
Femur fracture
1%
Lumbar vertebral fracture
1%
Post procedural haemorrhage
1%
Stress fracture
1%
Subdural haematoma
1%
Lethargy
1%
Subarachnoid haemorrhage
1%
Chronic kidney disease
1%
Urinary bladder haemorrhage
1%
Prostatitis
1%
Acute pulmonary oedema
1%
Laryngeal oedema
1%
Hyponatraemia
1%
Muscular weakness
1%
Rash erythematous
1%
Hyperviscosity syndrome
1%
Melaena
1%
Clostridium difficile infection
1%
Post procedural sepsis
1%
Pyelonephritis
1%
Cerebrovascular accident
1%
Respiratory disorder
1%
Lymphadenopathy
1%
Streptococcal sepsis
1%
Amyloidosis
1%
Influenza
1%
Pneumonia viral
1%
Coronary artery disease
1%
Pericardial haemorrhage
1%
Urosepsis
1%
Spinal stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Ibrutinib
Arm B: Zanubrutinib
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment Arm BExperimental Treatment3 Interventions
Group II: Treatment Arm APlacebo Group3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880
Bendamustine
2015
Completed Phase 3
~2950
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,785 Total Patients Enrolled
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,297 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,382 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My treatment goal is to reduce my tumor size before a stem cell transplant.I need blood thinners like warfarin.I do not have HIV, active hepatitis B or C, or any severe infection needing IV antibiotics.I don't have any severe illnesses that could affect my safety or the study's results.I have not had major surgery in the last 4 weeks.I need medication that strongly affects liver enzymes.I do not have serious heart problems like recent heart attacks or uncontrolled heart rhythm issues.I have not received any live vaccines in the last 4 weeks.My cancer is at stage II, III, or IV according to the Ann Arbor system.I have at least one tumor that can be measured.I have not received any treatments for mantle cell lymphoma.I am fully active or restricted in physically strenuous activity but can do light work.I have been diagnosed with lymphoma in my brain or spinal cord.I have no active cancer except possibly skin cancer or treated cervical cancer with no current signs of disease.I have not had a stroke or brain bleed in the last 6 months.My lymphoma diagnosis was confirmed with specific tests for cyclin D1 and other markers, or the t(11;14) genetic change.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm A
- Group 2: Treatment Arm B
Awards:
This trial has 1 awards, including:- 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.
In how many different medical clinics is this medical study being run today?
"So far, this clinical trial has enrolled patients from 49 different locations. If you are thinking about participating in the study, it might be helpful to choose a clinic that is close to your location to avoid extensive travel."
Answered by AI
Is Ibrutinib a new medication?
"The original study for Ibrutinib was completed in 1993 at the National Institutes of Health Clinical Center. So far, there have been a total of 19215 clinical trials completed worldwide. As of now, there are 577 live clinical trials, with many of these taking place in Lexington, Kentucky."
Answered by AI
What are the main conditions that ibrutinib has been found to alleviate?
"Ibrutinib is a medication that oncologists often prescribe to treat diffuse large b-cell lymphoma. Additionally, it can be used as part of treatment plans for hodgkin disease, other b-cell lymphomas, and polyangium."
Answered by AI
How many total participants are in this clinical trial?
"This trial is no longer enrolling patients. However, there are presently 1759 trials actively searching for patients with mantle cell lymphoma (mcl) and 577 trials for Ibrutinib that are still recruiting."
Answered by AI
Is Ibrutinib known to cause any life-threatening side effects?
"Ibrutinib is a Phase 3 drug, which means that while there is some data supporting its efficacy, there is also multiple rounds of data confirming its safety. Consequently, our team at Power has given it a score of 3."
Answered by AI
Are we still looking for more participants for this experiment?
"Unfortunately, this specific trial is no longer recruiting patients. It was initially posted on May 16th, 2013 and had its last update on November 3rd, 2022. There are other ongoing trials though; as of now, there are 1759 clinical trials for mantle cell lymphoma (mcl) and 577 for Ibrutinib enrolling patients."
Answered by AI
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