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Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Sponsor changed: Ono Pharmaceutical Co. Ltd to Ono Pharmaceutical Co., Ltd. Primary completion date changed from estimate of Mar 31, 2027 to Jan 27, 2026v18 Show 1 more changeShow less
    • Primary completion date changed from estimate of Mar 31, 2027 to Jan 27, 2026

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 112 to confirmed 119 · Study sites: 45 to 39v17 Show 2 more changesShow less
    • Enrollment target: estimated 112 to confirmed 119
    • Study sites: 45 to 39
  3. Re-verified, no change to tracked fieldsv16
  4. Site details revised at 12 of 45 sitesv15
  5. Site details revised at 7 of 45 sitesv14
Show 12 earlier versionsHide 12 earlier versions
  1. Site details revised at 10 of 45 sitesv13
  2. Re-verified, no change to tracked fieldsv12
  3. Study sites: 44 to 45v11
  4. Study sites revised (44)v10 See this version in full on ClinicalTrials.gov ↗
  5. Primary completion date: Jun 30, 2024 to Mar 31, 2027 Completion date: Jul 1, 2026 to Mar 31, 2027 · Study sites revised (44)v9 Show 2 more changesShow less
    • Completion date: Jul 1, 2026 to Mar 31, 2027
    • Study sites revised (44)

    See this version in full on ClinicalTrials.gov ↗

  6. Site details revised at 2 of 44 sitesv8
  7. Site details revised at 2 of 44 sitesv7
  8. Primary endpoints revised (4) Study sites: 30 to 44 · Primary completion date: May 31, 2024 to Jun 30, 2024 · Eligibility criteria expanded, about 13 words · 1 morev6 Show 4 more changesShow less
    • Study sites: 30 to 44
    • Primary completion date: May 31, 2024 to Jun 30, 2024
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 3 of 10 entries

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites revised (30)v5 See this version in full on ClinicalTrials.gov ↗
  10. Enrollment target: 44 to 112 Primary endpoints: 1 to 4 · Interventions: Tirabrutinib (Drug) to Tirabrutinib (Drug), Tirabrutinib (Drug), Tirabrutinib (Drug) · Eligibility criteria expanded, about 602 words · 2 morev4 Show 5 more changesShow less
    • Primary endpoints: 1 to 4
    • Interventions: Tirabrutinib (Drug) to Tirabrutinib (Drug), Tirabrutinib (Drug), Tirabrutinib (Drug)
    • Eligibility criteria expanded, about 602 words
    • Secondary endpoints revised (10)
    • Study arms: 1 to 3

    See this version in full on ClinicalTrials.gov ↗

  11. Start date: Sep 1, 2021 to Dec 29, 2021 Study sites: 25 to 30 · Eligibility criteria shortened, about 137 words · Secondary endpoints revised (10)v3 Show 3 more changesShow less
    • Study sites: 25 to 30
    • Eligibility criteria shortened, about 137 words
    • Secondary endpoints revised (10)

    See this version in full on ClinicalTrials.gov ↗

  12. Trial status: Not Yet Recruiting to Recruiting Study sites: 19 to 25 · Start date changed from estimate of Jul 1, 2021 to Sep 1, 2021 · Eligibility criteria expanded, about 146 wordsv2 Show 3 more changesShow less
    • Study sites: 19 to 25
    • Start date changed from estimate of Jul 1, 2021 to Sep 1, 2021
    • Eligibility criteria expanded, about 146 words

    See this version in full on ClinicalTrials.gov ↗

  1. 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.
This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in combination with one of two different high dose methotrexate based regimens (methotrexate/ temozolomide/rituximab or rituximab/methotrexate/procarbazine/ vincristine) as first line therapy in patients with newly diagnosed, treatment naïve PCNSL (Part B)
Trial Details
NCT Number NCT04947319
Lead Sponsor Ono Pharmaceutical Co., Ltd.
Conditions Refractory Primary Central Nervous System Lymphoma, Primary CNS Lymphoma
Enrollment 119 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov