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Recruiting NCT07104032

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

Phase III Interventional Relapsed/Refractory Primary Central Nervous System Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tirabrutinib, Rituximab, Temozolomide.
Who it may be relevant to
Registry conditions: Relapsed/Refractory Primary Central Nervous System Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Czechia, France, Italy, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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).

Interventions

  • Drug Tirabrutinib
    Administered orally.
  • Drug Rituximab
    Administered intravenously (IV).
  • Drug Temozolomide
    Administered orally.

Primary outcome measures

  • Progression Free Survival (PFS) [Time frame: Estimated up to 24 months]
Secondary outcome measures (9)
  • Overall Response Rate (ORR) [Time frame: Estimated up to 48 months]]
  • Overall Survival (OS) [Time frame: Estimated up to 48 months]
  • Complete Response Rate (CRR) [Time frame: Estimated up to 48 months]
  • Best Overall Response (BOR) [Time frame: Estimated up to 48 months]]
  • Time to Response (TTR) [Time frame: Estimated up to 48 months]
  • Time to Complete Response (TTCR) [Time frame: Estimated up to 48 months]
  • Duration of Response (DOR) [Time frame: Estimated up to 48 months]
  • Disease Free Survival (DFS) [Time frame: Estimated up to 48 months]
  • Change from Baseline in Corticosteroid Dose [Time frame: Baseline, estimated up to 48 months]

Eligibility criteria

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:
  • 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.
  • 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:
  • Equivalent of up to 10 milligram per day (mg/day) of prednisone for a disease other than PCNSL
  • Equivalent of up to 50 mg/day of prednisone (equal to 8 mg/day dexamethasone) for participants with lesions of the brain and/or spinal cord
  • Active malignancy, other than PCNSL requiring systemic therapy
  • Poorly controlled comorbidity, or history of medical conditions contraindicated per Investigator assessment
  • Participants who are unable to swallow oral medication
  • Prior Bruton's tyrosine kinase inhibitor treatment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 23 centers
  • Mayo Clinic Cancer Center — Phoenix
  • HonorHealth Cancer Center — Scottsdale
  • Providence Medical Foundation — Fullerton
  • UC Irvine Health — Orange
  • Yale Cancer Center — New Haven
  • John Hopkins University — Washington D.C.
  • University of Florida Gainesville — Gainesville
  • Mayo Clinic Cancer Center — Jacksonville
  • … and 15 more centers
France · 2 centers
  • Hôpitaux de Marseille — Marseille
  • Hospital Center University De Montpellier — Montpellier
Spain · 2 centers
  • Hospital Clínic de Barcelona — Barcelona
  • Hospital Universitario 12 De Octubre — Madrid
Czechia · 1 center
  • University Hospital Ostrava — Ostrava
Italy · 1 center
  • ASST Spedali Civili di Brescia — Brescia

Publications

  • Nayak L, Grommes C, Psoinos C, Reu FJ, Takazawa A, Uttarwar M, Xia B, Carvajal LA, Kim S, Sherman ML, Batchelor TT. IGNITE: a phase III study of tirabrutinib versus rituximab and temozolomide combination therapy in relapsed/refractory primary central nervous system lymphoma. Future Oncol. 2026 Jun;22(15):1751-1757. doi: 10.1080/14796694.2026.2683574. Epub 2026 Jun 19. PMID 42317052

Identifiers

NCT: NCT07104032 · ONO-4059-17 · 2025-523389-26-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗