Who Can Participate in the PROSPECT Study?
Adults at least 18 years of age who have been newly diagnosed with PCNSL.
These are not the only eligibility criteria for this research study. A clinical research team member will help determine if this study is right for you based on all eligibility criteria.
About the PROSPECT Study
Current treatment options for PCNSL are limited, and there are no medications approved specifically for the treatment of PCNSL in the United States. New treatment options are needed to improve the prognosis for those with PCNSL.
Before a new medicine can become available to the public, it must first be tested in clinical trials. The PROSPECT study is a clinical trial to evaluate the safety and effectiveness of an investigational oral medicine called tirabrutinib for potential treatment of PCNSL patients.
If you have been newly diagnosed with PCNSL and have not yet received any treatment, you will be in Part B of this study. Part B of the study will look at the safety and effectiveness of tirabrutinib when given together with standard of care chemotherapy treatments that are used to treat newly diagnosed patients. About 70 participants will be enrolled to Part B in the PROSPECT study in the United states.
By choosing to participate, you can help make a difference for thousands of others diagnosed with PCNSL.
Tirabrutinib has been approved and is currently marketed in Japan for relapsed or refractory (R/R) PCNSL patients.
What To Expect
If you choose to participate, the study team will complete a thorough screening to ensure that this study is suitable for you. Screening will include a physical exam, blood and urine samples, echocardiogram, ECG, eye exam, chest X-ray, CT, MRI and/or PET scans, lumbar puncture, and possible biopsy.
All participants will receive tirabutinib orally, once a day in multiple 28-day cycles, in addition to one of two high-dose methotrexate regiments:
- MTR: Methotrexate/ temozolomide/ rituximab
- R-MPV: Rituximab/ methotrexate/ procarbazine/ vincristine
The medications that make up MTR and R-MPV are given by different routes (some will be given intravenously while others will need to be swallowed).
Your exact treatment regimen will depend on the type of PCNSL you have and will be determined by your study doctor.
The number of study treatment cycles completed will vary. You may continue taking tirabrutinib for as long as you and your doctor believe it is of benefit to you. You may choose to leave the study at any time, for any reason. Choosing to not participate will not impact your future medical care in any way.
You will need to attend regular appointments so the study team can monitor how you are responding to the study medicine. You will have an additional follow-up visit about one month after completing your final treatment cycle, and the study team will call you to check in about every 6 months thereafter.
