Deciphera- Tirabrutinib vs Rituximab & Temozolomide in Relapsed/Refractory PCNSL (ONO-4059-17) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

This study is for people who have a type of cancer in the brain or spinal cord called primary central nervous system lymphoma. Their cancer has either come back or did not get better with earlier treatment. The goal of the study is to learn better ways to treat this hard to treat cancer and help patients have better outcomes.

Who Can Participate in the Study?

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 Group
Adults

What is Involved?

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.

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
Protocol Number
IRB: PRO00119479
NCT: NCT07104032
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
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