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ibrutinib for Mantle Cell Lymphoma

Phase 2
Waitlist Available
Led By Barbara Pro, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial is testing a drug to see if it can help maintain remission for patients with mantle cell lymphoma who have responded to chemotherapy.

Who is the study for?
This trial is for patients with mantle cell lymphoma who've responded to induction chemotherapy. They must have finished chemo at least 14 days ago but no more than 90 days prior, or show engraftment post-auto stem cell transplant. Participants need an ECOG performance status of <=2, indicating they can perform daily activities with some limitations.Check my eligibility
What is being tested?
The study tests if the drug Ibrutinib is effective as a maintenance therapy after initial chemo in MCL patients. It involves taking Ibrutinib and monitoring its effects on the disease through lab biomarker analysis to see how well it helps control cancer growth.See study design
What are the potential side effects?
Ibrutinib may cause side effects like diarrhea, bleeding problems, high blood pressure, infections due to low white blood cells count, fatigue, and muscle and bone pain. The severity of these side effects can vary from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the Progression-free Survival (PFS) Rate After 3 Years
Secondary outcome measures
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Overall Survival (OS) After 4 Years
Rate of Conversion From Partial Response (PR) to Complete Response (CR)
Other outcome measures
Compare Minimum Residual Disease (MRD) Results Overtime by Polymerase Chain Reaction (PCR) and Correlate These With PFS and OS

Side effects data

From 2018 Phase 3 trial • 391 Patients • NCT01578707
34%
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%
Renal Impairment
1%
Muscle Strain
1%
Bronchitis
1%
Conjunctivitis
1%
Sepsis Syndrome
1%
Pulmonary Mass
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

1Treatment groups
Experimental Treatment
Group I: Treatment (ibrutinib)Experimental Treatment2 Interventions
Patients receive ibrutinib orally PO QD on days 1-28. Courses repeat every 28 days for up to 4 years in the absence of disease progression, unacceptable toxicity, or patient preference.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tyrosine
FDA approved

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,194 Total Patients Enrolled
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,481 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,630 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other similar studies have been undertaken before this one?

"In total, there are 202 ibrutinib clinical trials ongoing in 44 countries and 1482 cities. The first study was sponsored by Baxter Healthcare Corporation in 2007. That initial trial completed its Phase 4 drug approval stage with 4640 patients enrolled. In the years since that first study, 917 more have been conducted."

Answered by AI

Could you direct me to other papers that have been published on ibrutinib's efficacy?

"ibrutinib was first studied in 2007. So far, there have been 917 completed trials and 202 studies are actively recruiting patients. Many of these locations for active recruitment are situated in Cleveland, Ohio."

Answered by AI

How many study participants are helping to test this new medication?

"Unfortunately, this study is not currently looking for new patients. It was originally posted on 1/1/2015 and was last edited on 4/30/2021. However, there are many other trials that may be of interest; as of right now, 1761 clinical trials are actively enrolling patients with stage iii mantle cell lymphoma and 202 studies for ibrutinib are also seeking participants."

Answered by AI

How has ibrutinib been found to be useful in the medical field?

"Ibrutinib is the most common amino acid supplementation therapy. It can also effectively manage renal dysfunction, chronic lymphocytic leukemia (cll), and kidney failure."

Answered by AI

Are there any life-threatening dangers associated with ibrutinib?

"Ibrutinib's safety is supported by data from Phase 2 trials, but since there is no efficacy data, it received a score of 2."

Answered by AI

Where are the different sites for this trial?

"So far, there are 5 clinical trial sites operational for this study. Some notable locations include Cleveland Clinic in Cleveland, Northwestern University in Chicago, and the University of Utah Salt Lake City."

Answered by AI

Are there any opportunities for volunteers yet?

"This study is not currently looking for new patients, as indicated by the last update to the trial on April 30th, 2021. However, there are other similar trials that might be of interest. There are 1761 studies actively recruiting for stage iii mantle cell lymphoma and 202 ibrutinib trials with open enrollment at this time."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ibrutinib After Intensive Induction in Treating Patients With Previously Untreated Mantle Cell Lymphoma
2015. "Ibrutinib After Intensive Induction in Treating Patients With Previously Untreated Mantle Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02242097.
All > Mantle Cell Lymphoma
~4 spots leftby Apr 2025
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