Study Summary
This trial is testing whether ibrutinib, a study drug, can be used in conjunction with an established chemotherapy regimen to treat primary central nervous system lymphoma.
Eligible Conditions
- Lymphoma
- Adult Patients With Newly Diagnosed or Relapsed or Refractory Primary Central Nervous System Lymphoma (PCNSL)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 3 Secondary · Reporting Duration: 2 years
1 year
define the Maximum Tolerated Dose (MTD) of ibrutinib (phase I)
define the Maximum Tolerated Dose (MTD) of ibrutinib in combination with high-dose Methotrexate (HD-MTX)
safety/tolerability of ibrutinib in patients by assessing the frequency and severity of adverse events
Week 48
progression free survival
2 years
Duration of response
progression free survival (phase II)
Trial Safety
Safety Progress
Side Effects for
Ibrutinib + Rituximab
43%Infusion related reaction
31%Diarrhoea
25%Arthralgia
24%Hypertension
23%Anaemia
23%Nausea
23%Oedema peripheral
21%Cough
21%Muscle spasms
17%Back pain
17%Dyspepsia
17%Fatigue
17%Headache
16%Neutropenia
16%Pyrexia
16%Asthenia
16%Nasopharyngitis
16%Insomnia
15%Urinary tract infection
15%Atrial fibrillation
15%Bronchitis
13%Upper respiratory tract infection
13%Influenza
13%Dizziness
13%Pain in extremity
12%Hypokalaemia
12%Increased tendency to bruise
12%Visual acuity reduced
12%Lacrimation increased
12%Constipation
12%Ecchymosis
11%Pneumonia
11%Dyspnoea
11%Epistaxis
9%Cataract
9%Contusion
9%Fall
9%Vision blurred
9%Gastrooesophageal reflux disease
9%Petechiae
9%Rash erythematous
8%Eye irritation
8%Photophobia
8%Herpes zoster
8%Respiratory tract infection
8%Oral herpes
8%Tumour flare
8%Sciatica
8%Pruritus
7%Traumatic haematoma
7%Thrombocytopenia
7%Dry eye
7%Hyponatraemia
7%Vomiting
7%Myalgia
7%Peripheral sensory neuropathy
7%Rhinorrhoea
7%Rash maculo-papular
7%Blood Creatinine Increased
5%Sinusitis
5%Hyperuricaemia
5%Gout
5%Palpitations
5%Vitreous floaters
5%Abdominal pain
5%Abdominal pain upper
5%Gastritis
5%Dry mouth
5%Influenza like illness
5%Cellulitis
5%Stomatitis
5%Chest pain
5%Conjunctivitis
5%Folliculitis
5%Iron deficiency
5%Rhinitis
5%Osteoarthritis
5%Paraesthesia
5%Basal cell carcinoma
5%Oropharyngeal pain
5%Skin lesion
5%Blood Uric Acid Increased
4%Decreased appetite
4%Productive cough
3%Erysipelas
3%Cardiac failure
3%Myocardial ischaemia
3%Gastroenteritis
3%Lung disorder
3%Acute kidney injury
1%Hypertrophic cardiomyopathy
1%Pneumonia pneumococcal
1%Atypical pneumonia
1%Leukopenia
1%Angina unstable
1%Pulmonary sepsis
1%Cardiac tamponade
1%Left ventricular failure
1%Prinzmetal angina
1%Ulcerative keratitis
1%Gait disturbance
1%Melaena
1%General physical health deterioration
1%Cholecystitis
1%Pneumonia bacterial
1%Arthritis bacterial
1%Clostridium difficile colitis
1%Pneumonia viral
1%Cholecystitis acute
1%Urosepsis
1%Osteomyelitis
1%Sepsis
1%Streptococcal bacteraemia
1%Respiratory syncytial virus infection
1%Staphylococcal bacteraemia
1%Pelvic fracture
1%Subcutaneous abscess
1%Subdural haematoma
1%Femur fracture
1%Lower limb fracture
1%Spinal fracture
1%Breast cancer metastatic
1%Lactic acidosis
1%Psoriatic arthropathy
1%Synovial cyst
1%Joint swelling
1%Soft tissue necrosis
1%Mobility decreased
1%Small cell lung cancer
1%Squamous cell carcinoma
1%Lumbar radiculopathy
1%Breast cancer
1%Prostate cancer
1%Syncope
1%Bronchopneumopathy
1%Purpura
1%Urinary retention
1%Prostatitis
1%Pulmonary oedema
1%Eczema
Trial Design
4 Treatment Groups
Arm C: Participants with refractory/recurrent PCNSL or refractory/recurrent SCNS...
1 of 4
Arm A: Participants with refractory/recurrent PCNSL or refractory/recurrent SCNS...
1 of 4
Arm B: Participants with refractory/recurrent PCNSL or refractory/recurrent SCNS...
1 of 4
Arm D: Participants with refractory/recurrent PCNSL or refractory/recurrent SCNS...
1 of 4
Experimental Treatment
109 Total Participants · 4 Treatment Groups
Primary Treatment: Ibrutinib · No Placebo Group · Phase 1 & 2
Arm C: Participants with refractory/recurrent PCNSL or refractory/recurrent SCNSLExperimental Group · 3 Interventions: Ibrutinib, Rituximab + HD- Methotrexate (MTX), HD- Methotrexate (MTX) · Intervention Types: Drug, Drug, Drug
Arm A: Participants with refractory/recurrent PCNSL or refractory/recurrent SCNSLExperimental Group · 3 Interventions: Ibrutinib, Rituximab + HD- Methotrexate (MTX), HD- Methotrexate (MTX) · Intervention Types: Drug, Drug, Drug
Arm B: Participants with refractory/recurrent PCNSL or refractory/recurrent SCNSLExperimental Group · 3 Interventions: Ibrutinib, Rituximab + HD- Methotrexate (MTX), HD- Methotrexate (MTX) · Intervention Types: Drug, Drug, Drug
Arm D: Participants with refractory/recurrent PCNSL or refractory/recurrent SCNSLExperimental Group · 4 Interventions: procarbazine, Ibrutinib, Rituximab + HD- Methotrexate (MTX), HD- Methotrexate (MTX) · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Who is running the clinical trial?
Janssen Biotech, Inc.Industry Sponsor
29 Previous Clinical Trials
18,700 Total Patients Enrolled
2 Trials studying Lymphoma
14 Patients Enrolled for Lymphoma
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,821 Previous Clinical Trials
584,210 Total Patients Enrolled
148 Trials studying Lymphoma
7,711 Patients Enrolled for Lymphoma
Pharmacyclics LLC.Industry Sponsor
112 Previous Clinical Trials
14,422 Total Patients Enrolled
53 Trials studying Lymphoma
8,709 Patients Enrolled for Lymphoma
Christian Grommes, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
171 Total Patients Enrolled
4 Trials studying Lymphoma
107 Patients Enrolled for Lymphoma
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:and have no major medical or psychiatric illness that would preclude their participation are eligible for study enrollment
You must be 18 years or older and have no major medical or psychiatric conditions in order to participate in this study.
No patient should receive more than two CNS therapies as first-line treatment.
If you have a parenchymal lesion, your imaging must show unequivocal evidence of disease progression 21 days before you can enroll in this study
Lymphoma that is documented by examination of tissue samples to be present in the brain (PCNSL) or throughout the body (systemic DLBCL).
People who have had a relapse or resistance to multiple treatments for primary central nervous system lymphoma (PCNSL) or secondary central nervous system lymphoma (SCNSL), or who have been newly diagnosed with PCNSL, may be eligible to participate in this study.
No platelet transfusion for 21 days before registering for the study
Participants must have an ECOG performance status of 0, 1, or 2.
About The Reviewer
Michael Gill - B. Sc.
First Published: October 29th, 2021
Last Reviewed: November 5th, 2022
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Krebs, Simone, Audrey Mauguen, Onur Yildirim, Vaios Hatzoglou, Jasmine H. Francis, Lauren R. Schaff, Ingo K. Mellinghoff, Heiko Schöder, and Christian Grommes. 2021. “Prognostic Value of [18F]FDG PET/CT in Patients with CNS Lymphoma Receiving Ibrutinib-based Therapies”. European Journal of Nuclear Medicine and Molecular Imaging. Springer Science and Business Media LLC. doi:10.1007/s00259-021-05386-0.
- Grommes, Christian, Sarah S. Tang, Julia Wolfe, Thomas J. Kaley, Mariza Daras, Elena I. Pentsova, Anna F. Piotrowski, et al.. 2019. “Phase 1b Trial of an Ibrutinib-based Combination Therapy in Recurrent/refractory CNS Lymphoma”. Blood. American Society of Hematology. doi:10.1182/blood-2018-09-875732.
- Krebs, Simone, Audrey Mauguen, Onur Yildirim, Vaios Hatzoglou, Jasmine H. Francis, Lauren R. Schaff, Ingo K. Mellinghoff, Heiko Schöder, and Christian Grommes. 2021. “Prognostic Value of [18F]FDG PET/CT in Patients with CNS Lymphoma Receiving Ibrutinib-based Therapies”. European Journal of Nuclear Medicine and Molecular Imaging. Springer Science and Business Media LLC. doi:10.1007/s00259-021-05386-0.
- 2014. "Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Patients With Newly Diagnosed or Refractory/Recurrent Primary Central Nervous System Lymphoma (PCNSL) and Refractory/Recurrent Secondary Central Nervous System Lymphoma (SCNSL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02315326.
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