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Kinase Inhibitor
Ibrutinib for Central Nervous System Lymphoma
Phase 1
Waitlist Available
Led By Christian Grommes, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically documented PCNSL or histologically documented systemic diffuse large B-cell lymphoma (DLBCL)
Participants must have an ECOG performance status of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to see if it is safe and more effective than the current standard of care for people with a certain type of lymphoma that has come back or does not respond to treatment.
Who is the study for?
Adults with recurrent or refractory primary or secondary central nervous system lymphoma who have had at least one prior CNS therapy can join. They must be able to undergo MRI/CT scans, sign consent, and meet specific health criteria like adequate organ function and blood counts. Women of childbearing age need a negative pregnancy test and agree to birth control measures.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of combining three drugs: Ibrutinib, Rituximab, and Lenalidomide for patients with certain types of brain lymphomas that haven't responded well to previous treatments. The goal is to see if this combination works better than standard approaches.See study design
What are the potential side effects?
Possible side effects include changes in blood counts leading to increased infection risk or bleeding problems, fatigue, digestive issues such as nausea or diarrhea, liver problems indicated by altered blood tests, allergic reactions to the drugs used in treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed as PCNSL or DLBCL through tissue examination.
Select...
I am able to get out of my bed or chair and move around.
Select...
My recent scans show my brain disease is getting worse.
Select...
I am 18 years old or older.
Select...
I have had at least one treatment for my brain condition.
Select...
My central nervous system lymphoma has returned or is not responding to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
maximum tolerated dose (MTD) of ibrutinib
Secondary outcome measures
progression free survival
Side 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%
Mouth ulceration
5%
Onychomycosis
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%
Osteoporosis
3%
Bladder transitional cell carcinoma
3%
Tinnitus
3%
Inguinal hernia
3%
Hypoalbuminaemia
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%
Haemolytic anaemia
1%
Haemorrhagic disorder
1%
Wound infection staphylococcal
1%
Cardiac failure acute
1%
Viral infection
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
1Treatment groups
Experimental Treatment
Group I: ibrutinib in combination with rituximab and lenalidomideExperimental Treatment3 Interventions
Ibrutinib will be given day 1-28; Lenalidomide will be given day 1-21; Rituximab will be given on day 1. Rituximab is given for 6 cycles; Lenalidomide is given for 12 cycles; Ibrutinib is continued until disease progression, intolerable toxicity or death.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880
Lenalidomide
2005
Completed Phase 3
~1480
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,795 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,934 Previous Clinical Trials
588,785 Total Patients Enrolled
4 Trials studying Central Nervous System Lymphoma
161 Patients Enrolled for Central Nervous System Lymphoma
Christian Grommes, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
217 Total Patients Enrolled
1 Trials studying Central Nervous System Lymphoma
33 Patients Enrolled for Central Nervous System Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stem cell transplant from a donor.I am currently taking medication that affects liver enzyme CYP3A.I am currently on medication that suppresses my immune system.I have heart problems and abnormal heart test results.My cancer is confirmed as PCNSL or DLBCL through tissue examination.I am able to get out of my bed or chair and move around.My bone marrow and organs are functioning well.I've had brain radiation therapy within the last 3 weeks.My recent scans show my brain disease is getting worse.My tests show lymphoma in my spinal fluid or images suggest it, confirmed 21 days before joining the study.I currently have an untreated, active infection.My diabetes is not well-managed.I am not pregnant or nursing.I am 18 years old or older.I have received treatment with radio- or toxin-immunoconjugates within the last 70 days.I am allergic to ibrutinib, thalidomide, or lenalidomide.I have had at least one treatment for my brain condition.I am currently being treated for cancer that has spread outside my brain.I am currently using other cancer treatments.I have recently had chemotherapy, monoclonal antibodies, or targeted cancer therapy.My central nervous system lymphoma has returned or is not responding to treatment.I have a history of hepatitis B or C.I am unable to participate in all required study activities due to my health.I am currently receiving treatment for another cancer.I am taking warfarin or similar blood thinners.I need more than 8 mg of dexamethasone or its equivalent daily.I had major surgery recently.I cannot swallow pills or have a serious digestive system issue.I have a bleeding disorder or hemophilia.
Research Study Groups:
This trial has the following groups:- Group 1: ibrutinib in combination with rituximab and lenalidomide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
How many locales are being used to manage this research endeavor?
"Memorial Sloan Kettering Commack, Memorial Sloan Kettering Westchester and Memorial Sloan Kettering Nassau are some of the sites recruiting for this clinical trial. In addition to these three locations, there are an additional 7 medical centres in participation."
Answered by AI
What is the current number of participants in this clinical research?
"This particular medical trial is not longer recruiting patients, having been initially posted on the 22nd of January 2019 and last updated on 11th August 2022. Those wishing to join a similar study may wish to look at the currently available 2339 clinical trials for neoplasm metastasis or 721 Ibrutinib studies that are actively looking for participants."
Answered by AI
Has Ibrutinib achieved official recognition from the Food and Drug Administration?
"Due to the limited amount of existing data concerning Ibrutinib's safety and efficacy, this medication received a rating of 1."
Answered by AI
Could you please elaborate on other research projects related to Ibrutinib?
"Currently, 721 clinical trials related to Ibrutinib are underway. Of those studies, 149 have advanced to the third phase of testing. Although most research is conducted in Ascoli Piceno Provincia, 28285 sites across the globe are also running investigations into this treatment."
Answered by AI
What medical conditions is Ibrutinib frequently utilized to treat?
"Studies have indicated that Ibrutinib can be an effective treatment for diffuse large b-cell lymphoma (DLBCL) and certain types of B-cell Lymphomas in individuals who have had at least two systemic chemotherapy treatments."
Answered by AI
Could you tell me if enrollment is still open for this clinical trial?
"Unfortunately, recruitment is not ongoing for this particular trial. It was first posted on January 22nd 2019 and has since been updated last August 11th 2022. If you are seeking other studies, 2339 trials related to neoplasm metastasis and 721 focusing on Ibrutinib still need participants."
Answered by AI
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