Who Can Participate in the PROSPECT Study?
Adults at least 18 years of age who have been diagnosed with either newly diagnosed PCNSL or Relapsed/Refractory (R/R) PCNSL (PCNSL that did not improve or only temporarily improved from previous treatment with high-dose methotrexate) may be eligible to participate.
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.
If you are interested in participating, please reach out to the below listed study location that is closest to you.
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 who have had at least one prior methotrexate contained regimen.
If you have PCNSL that has not responded to or returned after prior treatment, you will be in Part A of the study. Part A will explore the safety and the effectiveness of tirabrutinib when given without any additional chemotherapy. About 45 participants will be enrolled to Part A in the PROSPECT study in the United States.
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 PROSEPCT 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 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 wil be taken orally once a day in multiple 28-day cycles. If you are newly diagnosed with PCNSL, you will also be given 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.
