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Bruton's Tyrosine Kinase (BTK) Inhibitor
Tirabrutinib for Central Nervous System Lymphoma
Phase 2
Recruiting
Research Sponsored by Ono Pharmaceutical Co. Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG PS of 0, 1 or 2
Patients aged ≥ 18 years on the day of consenting to the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will study the effects of a new drug, tirabrutinib, on patients with relapsed or refractory PCNSL (part A), and on patients with newly diagnosed, treatment naïve PCNSL (part B).
Who is the study for?
Adults with a confirmed diagnosis of Primary Central Nervous System Lymphoma (PCNSL) who have either not been treated before or whose disease has returned after treatment. Participants must be in good enough health, as determined by organ function tests, and have a life expectancy of at least 3 to 6 months depending on the part of the trial they're entering.Check my eligibility
What is being tested?
The study is testing Tirabrutinib alone for those with relapsed PCNSL (Part A), and in combination with high-dose methotrexate-based regimens for newly diagnosed patients (Part B). The goal is to see how well it works and what side effects occur.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation, liver issues, bleeding problems due to blood thinners interaction, infections risk increase including HIV or hepatitis reactivation if previously infected. Specific side effects from tirabrutinib are not listed but may resemble other drugs in its class.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
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I am 18 years old or older.
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I have a brain lesion larger than 1 cm, confirmed by a recent MRI.
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I have not received any treatment for my brain lymphoma.
Select...
I have been diagnosed with primary central nervous system lymphoma.
Select...
My brain lymphoma has returned or didn't respond to treatment with high-dose methotrexate.
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
Complete response rate (CRR) (Part B)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during induction (Part B)
Overall response rate (ORR) (Part A)
+1 moreSecondary outcome measures
Best overall response (BOR) (Part A and B)
Change in corticosteroid dose (Part A)
Duration of response (DOR) (Part A and B)
+7 moreSide effects data
From 2019 Phase 2 trial • 152 Patients • NCT0310094211%
Alanine aminotransferase increased
11%
Arthralgia
11%
Rash
11%
Upper respiratory tract infection
11%
Aspartate aminotransferase increased
11%
Fatigue
8%
Gastroenteritis viral
8%
Nasopharyngitis
8%
Diarrhoea
8%
Dizziness
8%
Pyrexia
5%
Laryngitis
5%
Lower respiratory tract infection
5%
Oral herpes
5%
Sinusitis
5%
Myalgia
5%
Dental caries
5%
Neutropenia
5%
Pruritus generalised
5%
Lymphadenopathy
5%
Bronchitis
5%
Nausea
5%
Vomiting
3%
Rheumatoid arthritis
3%
Acute coronary syndrome
3%
Fall
3%
Pancreatitis acute
3%
Suicidal ideation
3%
Seasonal allergy
3%
Furuncle
3%
Influenza
3%
Urinary tract infection
3%
Osteoarthritis
3%
Migraine
3%
Hyperhidrosis
3%
Anaemia
3%
Back pain
3%
Rash pruritic
3%
Insomnia
3%
Musculoskeletal pain
3%
Rash papular
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo to Tirabrutinib
Placebo on Placebo Controlled Period
Lanraplenib
Filgotinib
Tirabrutinib
Placebo to Lanraplenib
Placebo to Filgotinib
Trial Design
3Treatment groups
Experimental Treatment
Group I: Tirabrutinib monotherapy in patients with relapsed or refractory PCNSL (Part A)Experimental Treatment1 Intervention
Patients with relapsed or refractory PCNSL who meet eligibility criteria will be enrolled to receive tirabrutinib monotherapy.
Group II: Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL (Part B, Arm 2)Experimental Treatment1 Intervention
Patients with newly diagnosed treatment naïve PCNSL who meet eligibility criteria will be enrolled to receive tirabrutinib + rituximab/methotrexate/procarbazine/vincristine (R-MPV)
Group III: Tirabrutinib + MTR in patients with newly diagnosed, treatment naïve PCNSL (Part B, Arm 1)Experimental Treatment1 Intervention
Patients with newly diagnosed treatment naïve PCNSL who meet eligibility criteria will be enrolled to receive tirabrutinib + methotrexate/temozolomide/rituximab (MTR)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirabrutinib
2012
Completed Phase 2
~390
Find a Location
Who is running the clinical trial?
Ono Pharmaceutical Co. LtdLead Sponsor
154 Previous Clinical Trials
94,411 Total Patients Enrolled
Arata AoiStudy DirectorOno Pharma USA Inc
Project LeaderStudy DirectorOno Pharma USA Inc
12 Previous Clinical Trials
2,501 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for at least 6 more months.I can take care of myself and perform daily activities.I am 18 years old or older.You need to sign a paper saying you agree to participate before you can be checked for eligibility.I cannot swallow pills or have a condition affecting my stomach or intestines.I do not have an active infection or have not been hospitalized for an infection requiring IV antibiotics in the last 28 days.You have had an allergic reaction to the dye used in MRI scans.My kidney, liver, and bone marrow are functioning well.I have a brain lesion larger than 1 cm, confirmed by a recent MRI.I have had an organ transplant.I have not received any treatment for my brain lymphoma.I haven't taken systemic steroids regularly in the last 14 days, except for specific exceptions.I have been treated with a BTK inhibitor before.I have a brain lesion larger than 1 cm, confirmed by a recent MRI.You are expected to live for at least 3 more months.You have had a serious skin reaction called Stevens Johnson Syndrome or Toxic Epidermal Necrolysis in the past.I am unable to give consent due to a condition like dementia.My lymphoma has spread throughout my body.I am not pregnant or breastfeeding.I haven't taken any experimental drugs within the last 28 days or 5 half-lives, whichever is shorter.I haven't taken any CYP3A4 or P-gp inducer drugs in the last 14 days.I have another cancer besides PCNSL that needs treatment.My cancer is in the eye and has not spread to the brain.The medications methotrexate, temozolomide, rituximab, procarbazine, and vincristine are not safe for me.My heart's electrical cycle is longer than normal or I'm on medication that affects it.I do not have severe heart, lung, or liver diseases that could affect my treatment.I have tested positive for HIV, HTLV-1, hepatitis B, or hepatitis C.Requirements for being eligible to participate in Part B of the study.I have had moderate to severe liver problems.I have been diagnosed with primary central nervous system lymphoma.My brain lymphoma has returned or didn't respond to treatment with high-dose methotrexate.I was diagnosed with primary central nervous system lymphoma less than 3 months ago.I am taking up to 10 mg/day of prednisone for a condition that is not brain lymphoma.I haven't had certain cancer treatments or major surgery within specific time frames before starting tirabrutinib.I am taking up to 50 mg/day of prednisone for brain or spinal cord lesions.I have a bleeding disorder.My cancer is a non-B cell type of primary central nervous system lymphoma.I haven't taken blood thinners or antiplatelet drugs in the last 7 days.Requirements for being eligible to participate in the study (Part A).You have had severe side effects or allergic reactions to the medications used in the study before.My doctor thinks I can handle a high dose methotrexate treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Tirabrutinib monotherapy in patients with relapsed or refractory PCNSL (Part A)
- Group 2: Tirabrutinib + MTR in patients with newly diagnosed, treatment naïve PCNSL (Part B, Arm 1)
- Group 3: Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL (Part B, Arm 2)
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.
Have any other research projects been conducted with Tirabrutinib?
"Tirabrutinib was first trialed at the Plymouth Hospitals NHS Trust back in 2015 and 6 completed studies have since been conducted. Currently, two clinical trials are underway with one based out of Louisville, Kentucky."
Answered by AI
Is the enrollment phase of this clinical trial still open?
"As per the information held on clinicaltrials.gov, this trial is actively looking for participants. The study was made available online on December 29th 2021 and its details were last updated on June 15 2022."
Answered by AI
What potential perils does taking Tirabrutinib carry for those who ingest it?
"Tirabrutinib was assigned a score of 2 on the safety scale, as there is evidence that it can be tolerated but no proof yet to support its efficacy."
Answered by AI
Are there any facilities in North America offering this clinical experiment?
"Patients for this trial are being accepted at Norton Cancer Institute - St. Matthews in Louisville, Kentucky, The University of Kansas Cancer Center (KUCC) (Kansas City Cancer Center (KCCC)) - North in Kansas City, Missouri, Henry Ford Hospital in Detroit, Michigan and an additional 34 sites."
Answered by AI
Is this experiment a pioneering endeavor?
"Currently, two clinical trials are active for Tirabrutinib across 30 cities in three nations. This drug was first tested by Gilead Sciences in 2015 with a cohort of 202 patients and achieved Phase 1 approval status. Since then, six additional studies have been finalized."
Answered by AI
How many participants can this trial accommodate?
"This medical trial needs 112 patients that adhere to the requisite eligibility criteria. Potential research participants can join this study at Norton Cancer Institute - St. Matthews in Louisville, Kentucky and The University of Kansas Cancer Center (KUCC) (Kansas City Cancer Center (KCCC)) - North in Kansas City, Missouri."
Answered by AI
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