IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)

ClinicalTrials.gov ID: NCT07104032

Public ClinicalTrials.gov record NCT07104032. 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.

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ClinicalTrials.gov public records Last synced Sep 5, 2026, 11:41 PM EDT

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

Official title

A Phase 3, Multi-regional, Open-label, Randomized Study of Tirabrutinib vs Rituximab and Temozolomide in Participants With Relapsed/Refractory Primary Central Nervous System Lymphoma

Brief summary

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

The purpose of this clinical trial is to evaluate efficacy and safety of tirabrutinib alone compared with rituximab and temozolomide (R-TMZ) combination therapy in participants with Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL).

Study identification

NCT ID: NCT07104032
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Ono Pharmaceutical Co., Ltd.; Industry
Enrollment: 132 participants

Conditions and interventions

Conditions

Relapsed/Refractory Primary Central Nervous System Lymphoma

Interventions

Drug

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: Jun 11, 2026
Primary completion: Nov 30, 2027
Completion: Nov 30, 2029
Last update posted: Sep 2, 2026

2026 – 2029

United States locations

U.S. sites: 24
U.S. states: 15
U.S. cities: 20

Facility	City	State	ZIP	Site status
Mayo Clinic Cancer Center	Phoenix	Arizona	85054	Recruiting
HonorHealth Cancer Center	Scottsdale	Arizona	85251	Recruiting
Providence Medical Foundation	Fullerton	California	92835	Recruiting
UC Irvine Health	Orange	California	92868	Recruiting
Yale Cancer Center	New Haven	Connecticut	06520	Recruiting
John Hopkins University	Washington D.C.	District of Columbia	20016	Recruiting
University of Florida Gainesville	Gainesville	Florida	32610	Recruiting
Mayo Clinic Cancer Center	Jacksonville	Florida	32224	Recruiting
University of Maryland	Baltimore	Maryland	21201	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	02114	Recruiting
Beth Israel Deaconess Medical Center	Boston	Massachusetts	02115	Recruiting
Dana-Farber Cancer Institute	Boston	Massachusetts	02115	Recruiting
Mayo Clinic Cancer Center	Rochester	Minnesota	55905	Recruiting
Hackensack University Medical Center	Hackensack	New Jersey	07601	Recruiting
Atlantic Health Overlook Medical Center	Summit	New Jersey	07901	Recruiting
NYU Langone Health	New York	New York	10016	Recruiting
Columbia University Irving Medical Center	New York	New York	10032	Recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	10065	Recruiting
Duke University Medical Center	Durham	North Carolina	27710	Recruiting
Providence Neurological Specialties West	Portland	Oregon	97225	Recruiting
Penn State Health Milton S Hershey Medical Center	Hershey	Pennsylvania	17033	Recruiting
UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania	15232	Recruiting
Rhode Island Hospital	Providence	Rhode Island	02903	Recruiting
University of Washington	Seattle	Washington	98195	Recruiting

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

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07104032, 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 Sep 2, 2026 · Synced Sep 5, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07104032 live on ClinicalTrials.gov.

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