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

Description

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)

Conditions

Refractory Primary Central Nervous System Lymphoma, Primary CNS Lymphoma

Talk to us

Study Overview

On this page

Study Details

Study overview

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)

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

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

Condition
Refractory Primary Central Nervous System Lymphoma
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, United States, 35233

Phoenix

Mayo Clinic- Phoenix, Phoenix, Arizona, United States, 85054

Duarte

City of Hope Comprehensive Breast Cancer Center, Duarte, California, United States, 91010

Hollywood

Cedar Sinai Medical Cancer, Hollywood, California, United States, 90046

Irvine

University of California, Irvine, Irvine, California, United States, 92868

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

Aurora

University of Colorado Denver, Aurora, Colorado, United States, 80045

New Haven

Yale Cancer Center, New Haven, Connecticut, United States, 06510

Washington

Georgetown University, Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States, 20037

Jacksonville

Mayo Clinic- Jacksonville, Jacksonville, Florida, United States, 32224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Ono Pharmaceutical Co. Ltd,

    Project Leader, STUDY_DIRECTOR, Ono Pharma USA Inc

    Study Record Dates

    2027-03-31