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

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 Details

NCT ID
NCT07104032
Phase
PHASE3
Sponsor
Ono Pharmaceutical Co., Ltd.
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Tirabrutinib
  • Rituximab
  • Temozolomide
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Scottsdale, Arizona, United States|33.50921,-111.89903
  • Fullerton, California, United States|33.87029,-117.92534
  • Orange, California, United States|33.78779,-117.85311
  • New Haven, Connecticut, United States|41.30815,-72.92816

Key Eligibility Criteria

  • Pathology report confirming the diagnosis of B-cell PCNSL
  • 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 subsequently experienced disease progression
  • Refractory disease: Participants whose best response to the last treatment was stable disease or PD

For full eligibility, visit ClinicalTrials.gov.

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