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

NCT07104032 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-05-20

No results posted yet for this study

Summary

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).

Conditions

  • Relapsed/Refractory Primary Central Nervous System Lymphoma

Interventions

DRUG

Tirabrutinib

Administered orally.

DRUG

Rituximab

Administered intravenously (IV).

DRUG

Temozolomide

Administered orally.

Sponsors & Collaborators

Principal Investigators

  • Clinical Team · Deciphera Pharmaceuticals, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07104032 on ClinicalTrials.gov