Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)
Running, not enrolling · Phase 2
Conditions studied: Refractory Primary Central Nervous System Lymphoma, Primary CNS Lymphoma
In brief
This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in combination with one of two different high dose methotrexate based regimens (methotrexate/ temozolomide/rituximab or rituximab/methotrexate/procarbazine/ vincristine) as first line therapy in patients with newly diagnosed, treatment naïve PCNSL (Part B)
Key facts
- Study ID
- NCT04947319
- Run by
- Ono Pharmaceutical Co., Ltd.
- People needed
- 119
- Starts
- 2021-12-29
- Expected to finish
- 2027-03-31
- Last updated by the study team
- 2026-03-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Alabama at Birmingham School of Medicine — Birmingham, Alabama, United States
- Mayo Clinic- Phoenix — Phoenix, Arizona, United States
- City of Hope Comprehensive Breast Cancer Center — Duarte, California, United States
- University of California, Irvine — Irvine, California, United States
- Stanford University — Palo Alto, California, United States
- University of Colorado Denver — Aurora, Colorado, United States
- Yale Cancer Center — New Haven, Connecticut, United States
- Georgetown University, Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States
- Mayo Clinic- Jacksonville — Jacksonville, Florida, United States
- University of Miami-Sylvester Cancer Center — Miami, Florida, United States
- Orlando Health — Orlando, Florida, United States
- Moffitt Cancer Center- Miami — Pembroke Pines, Florida, United States
- Piedmont Healthcare — Atlanta, Georgia, United States
- University of Kentucky — Lexington, Kentucky, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute - Brigham & Women's Hospital — Boston, Massachusetts, United States
- University Of Michigan — Ann Arbor, Michigan, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- The University of Kansas Cancer Center (KUCC) (Kansas City Cancer Center (KCCC)) - North — Kansas City, Missouri, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Hackensack University Medical Center - John Theurer Cancer — Hackensack, New Jersey, United States
- Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI)) — Buffalo, New York, United States
- Memorial Sloan Kettering — New York, New York, United States
- Columbia University Irving Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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