About IGNITE

IGNITE is evaluating an investigational study drug in adults with primary central nervous system lymphoma (PCNSL). The study is looking at whether the drug has a favorable safety profile, stops disease progression, and helps those whose disease has returned after response to treatment (relapsed) or has not improved with prior treatment or came back rapidly after initially responding (refractory).

Who Can Participate?

To participate, you must:

  • Be at least 18 years of age
  • Have a diagnosis of B-cell PCNSL that has come back after treatment (relapsed) or has not improved with prior treatment or came back rapidly after initially responding (refractory)
  • Have undergone at least one previous therapy for PCNSL

Additional requirements will apply. The clinical research study team will discuss these with you.

Questions to ask your doctor

Study Participation

The length of participation in IGNITE will be different for each person. Throughout the study, participants will be closely monitored and will visit the research site regularly for assessments, procedures, and health checks. The number of cycles will vary per person, depending on what study drug is assigned and how they respond.

This study is made up of the following three periods:

Screening (up to 4 weeks)

A study doctor will evaluate interested individuals to find out if the clinical research study is a good match. Individuals will first need to give their consent, or permission, to join the study by reading and signing the informed consent form.

Investigational Treatment (28-day cycles)

Study participants will be randomly assigned to receive either the investigational study drug or a standard PCNSL treatment. They will visit the study site one to two times per cycle for study assessments and to receive their assigned study drug.

Follow-Up (ongoing)

Participants will return to the study site so that the study team can continue to monitor their health after they have stopped receiving their assigned study drug. There will be one study site visit 28 days after the last study drug dose and then one study visit every eight weeks as long as your cancer remains controlled. There will be a phone call with the study site staff once every three months for health checks.

About the Study Drug

IGNITE is being done to research an investigational study drug called tirabrutinib. It is an oral (taken by mouth) tablet taken once a day and is thought to disrupt a biological reaction in the malfunctioning lymphocytes (cancerous cells) to potentially prevent them from growing and spreading.

In this study, tirabrutinib is being compared to a standard PCNSL study drug called R-TMZ, a combination therapy of rituximab (intravenous [IV] infusion) and temozolomide (oral capsule). By doing this, researchers will have something to directly compare the investigational study drug to. This is necessary in clinical research, as it will help make the study results as accurate as possible.

No-Cost Study Drug and Support

All participants in this study will receive either the investigational study drug or the standard study drug at no cost. Support for study-related travel expenses may be available. All study site visits and procedures associated with the study will also be provided at no cost to you or your insurance, as applicable.