Purpose of this Study
If you join this study, you will be placed into one of two groups by chance. Most people will take a daily pill called tirabrutinib. A smaller group will receive standard treatment with a medicine called rituximab through a vein and another medicine called temozolomide taken by mouth. Treatment happens in cycles that last 28 days. Some people may keep taking the treatment as long as it is helping and safe. During the study, you will have regular doctor visits, scans such as MRI, lab tests, and check ins to watch your health.
Who Can Participate?
Eligibility
People may be able to join this study if they are 18 years old or older and have a type of brain cancer called primary central nervous system lymphoma that has come back or did not get better with treatment. They must have had at least one earlier treatment that included a medicine called methotrexate. They also need to have a tumor that can be seen on a brain scan and be well enough to take part in study visits and treatment. People cannot join if their cancer is outside the brain or if they have certain serious health problems.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing a new pill called tirabrutinib to see if it works better than the usual treatment for this type of brain cancer. Researchers want to find out which treatment helps people live longer without the cancer getting worse. The study also looks at how safe the treatments are and what side effects they may cause.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 3, Multi-regional, Open-label, Randomized Study of Tirabrutinib vs Rituximab and Temozolomide in Participants With Relapsed/Refractory Primary Central Nervous System Lymphoma
Principal Investigator
Katherine
Peters
Protocol Number
PRO00119479
NCT ID
NCT07104032
Phase
III
Enrollment Status
Open to Enrollment