IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central N… (NCT07104032) | Clinical Trial Compass
RecruitingPhase 3
IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
United States132 participantsStarted 2026-04
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion 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:
✓. One or more bi-dimensionally measurable brain lesions with a minimum diameter greater than or equal to (≥)1 centimeter (cm) × ≥1 cm in gadolinium-enhanced magnetic resonance imaging (MRI)
✓. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
✓. Adequate bone marrow, renal, and hepatic function per central lab values
✓. Participants must agree to comply with all defined contraceptive requirements
Exclusion criteria
✕. Participants with isolated intraocular PCNSL or spinal PCNSL with no brain lesions
✕. Participants with non-B-cell PCNSL
✕. Participants with systemic presence of lymphoma
✕. Refractory to temozolomide with or without rituximab-containing regimens in the last PCNSL treatment
✕. Concomitant systemic corticosteroid exposure within 14 days before starting study drug per Investigator assessment with the exception of the following:
✕. Active malignancy, other than PCNSL requiring systemic therapy