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

Study acronym: IGNITE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study sites: 35 to 36
  2. Minor Study sites: 33 to 35 Eligibility criteria expanded, about 19 words · Publications: details revised at 1 of 1 entry Show 2 more changesShow less
    • Eligibility criteria expanded, about 19 words
    • Publications: details revised at 1 of 1 entry
  3. Minor Study sites: 32 to 33v18
  4. Minor Trial sites expanded: 29 → 32 locationsv17
  5. Minor Study sites: 27 to 29v16
  6. Minor Trial sites expanded: 20 → 27 locationsv15
  7. Minor Study sites: 19 to 20v14
  8. Minor Study sites: 18 to 19v13
  9. Minor Trial sites expanded: 14 → 18 locations Start date changed from estimate of Jun 2026 to Jun 12, 2026v12 Show 1 more changeShow less
    • Start date changed from estimate of Jun 2026 to Jun 12, 2026
  10. Minor Trial sites expanded: 10 → 14 locations Start date: May 2026 to Jun 2026v11 Show 1 more changeShow less
    • Start date: May 2026 to Jun 2026
  11. Minor Study sites: 9 to 10v10
  12. Minor Study sites: 8 to 9 Start date: Apr 2026 to May 2026v9 Show 1 more changeShow less
    • Start date: Apr 2026 to May 2026
  13. Minor Trial sites expanded: 4 → 8 locations Start date: Mar 2026 to Apr 2026v8 Show 1 more changeShow less
    • Start date: Mar 2026 to Apr 2026
  14. Notable Changed Sponsor changed: Ono Pharmaceutical Co. Ltd to Ono Pharmaceutical Co., Ltd.
  15. Minor Study sites: 2 to 4 Start date: Feb 2026 to Mar 2026 · Study title expanded, about 1 wordv7 Show 2 more changesShow less
    • Start date: Feb 2026 to Mar 2026
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  16. Minor Study sites: 1 to 2v6
  17. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v5 Show 1 more changeShow less
    • Study sites: 0 to 1
  18. Notable Start date: Nov 2025 to Feb 2026v4
  19. Minor Re-verified, no change to tracked fieldsv3
  20. Minor Eligibility criteria expanded, about 6 wordsv2 See this version in full on ClinicalTrials.gov ↗
  21. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Number NCT07104032
Lead Sponsor Ono Pharmaceutical Co., Ltd.
Collaborators: Deciphera Pharmaceuticals, LLC
Conditions Relapsed/Refractory Primary Central Nervous System Lymphoma
Enrollment 132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov