Relapsed or refractory primary central nervous system lymphoma (R/R PCNSL) is a type of cancer that either does not improve from treatment (refractory) or improves only for a limited time (relapsed). Current treatment options for R/R 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 R/R PCNSL.
Before a new medicine can become available to the public, it must first be tested in a series of clinical trials. The PROSPECT study is evaluating the safety and effectiveness of an investigational oral medicine called Tirabrutinib for potential treatment of R/R PCNSL patients who have had at least 1 prior methotrexate contained regimen. About 45 participants will be enrolled in the the PROSPECT study in the United States.
By choosing to volunteer, you can help make a difference for thousands of others diagnosed with PCNSL.
Tirabrutinib has been approved and is currently marketed in Japan for R/R PCNSL patients.
What to Expect
If you choose to participate, the study team will complete a thorough screening to ensure you meet the requirements for this study. 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 Tirabrutinib that will be taken orally once a day in multiple 28-day cycles. Tirabrutinib should be taken on an empty stomach at approximately the same time every day. Participants may not receive other cancer treatments or therapies during their time in the study.
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 1 month after completing your final treatment cycle, and the study team will call you to check in about every 6 months thereafter.