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

Recruiting Phase 3 Interventional Study
Relapsed/Refractory Primary Central Nervous System Lymphoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
132 (estimated)
Sponsor
Ono Pharmaceutical Co., Ltd. · Industry
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria 1. Pathology report confirming the diagnosis of B-cell PCNSL 2. Relapsed or refractory B-cell PCNSL with at least 1 prior high-dose methotrexate (HD-MTX) based therapy for PCNSL: * Relapsed disease: Participants who achieved a response (CR, CRu, PR) to the last treatment and …
Contacts

Clinical Team

888-724-3274

clinicaltrials@deciphera.com

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