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Active, not recruiting Phase 2 Interventional

Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)

ClinicalTrials.gov ID: NCT04947319

Public ClinicalTrials.gov record NCT04947319. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 11:21 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-label Phase II Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Tirabrutinib in Patients With Primary Central Nervous System Lymphoma (PCNSL)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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)

Study identification

NCT ID
NCT04947319
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Ono Pharmaceutical Co., Ltd.
Industry
Enrollment
119 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 29, 2021 (Actual)
Primary completion
Jan 27, 2026 (Actual)
Completion
Mar 31, 2027 (Estimated)
Last update posted
Mar 30, 2026

2021 – 2027

United States locations

U.S. sites
39
U.S. states
25
U.S. cities
35
Facility City State ZIP Site status
University of Alabama at Birmingham School of Medicine Birmingham Alabama 35233 —
Mayo Clinic- Phoenix Phoenix Arizona 85054 —
City of Hope Comprehensive Breast Cancer Center Duarte California 91010 —
University of California, Irvine Irvine California 92868 —
Stanford University Palo Alto California 94304 —
University of Colorado Denver Aurora Colorado 80045 —
Yale Cancer Center New Haven Connecticut 06510 —
Georgetown University, Lombardi Comprehensive Cancer Center Washington D.C. District of Columbia 20037 —
Mayo Clinic- Jacksonville Jacksonville Florida 32224 —
University of Miami-Sylvester Cancer Center Miami Florida 33136 —
Orlando Health Orlando Florida 32806 —
Moffitt Cancer Center- Miami Pembroke Pines Florida 33028 —
Piedmont Healthcare Atlanta Georgia 30318 —
University of Kentucky Lexington Kentucky 40536 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
Dana-Farber Cancer Institute - Brigham & Women's Hospital Brigham and Women's Hospital Boston Massachusetts 02215 —
University Of Michigan Ann Arbor Michigan 41809 —
Henry Ford Hospital Detroit Michigan 48202 —
The University of Kansas Cancer Center (KUCC) (Kansas City Cancer Center (KCCC)) - North Kansas City Missouri 64154 —
University of Nebraska Medical Center Omaha Nebraska 68198 —
Hackensack University Medical Center - John Theurer Cancer Hackensack New Jersey 07601 —
Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI)) Buffalo New York 14263 —
Memorial Sloan Kettering New York New York 10022 —
Columbia University Irving Medical Center New York New York 10032 —
Levine Cancer Center Charlotte North Carolina 28204 —
Duke University School of Medicine Durham North Carolina 27705 —
Cleveland Clinic Cleveland Ohio 44106 —
Providence Health Cancer Center Portland Oregon 97239 —
Penn State Hershey Cancer Center Hershey Pennsylvania 17033 —
Abramson Cancer Center University of Pennsylvania Philadelphia Pennsylvania 19104 —
Hillman Cancer Center, University of Pittsburgh Pittsburgh Pennsylvania 15232 —
Lifespan Rhode Island Hospital Providence Rhode Island 02903 —
Vanderbilt-Ingram Cancer Center Nashville Tennessee 37232 —
Houston Methodist Research Institute (HMRI) Houston Texas 77030 —
MD Anderson Cancer Center Houston Texas 77030 —
The University of Utah - Huntsman Cancer Institute (HCI) Salt Lake City Utah 84112 —
The University of Vermont - Fletcher Allen Health Care Burlington Vermont 05401 —
Seattle Cancer Care Alliance Seattle Washington 98109 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04947319, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 30, 2026 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04947319 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →