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A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Jan 30, 2027 to Aug 11, 2026 Enrollment target: 85 to 83 · Eligibility criteria expanded, about 7 words · Secondary endpoints: details revised at 8 of 37 entries Show 3 more changesShow less
    • Enrollment target: 85 to 83
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 8 of 37 entries
  2. Re-verified, no change to tracked fieldsv20
  3. Trial status: Recruiting to Active, Not Recruiting Study sites revised (40)v19 Show 1 more changeShow less
    • Study sites revised (40)

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Dec 21, 2025 to Jan 30, 2027 Completion date: Aug 31, 2029 to Oct 10, 2030 · Study sites revised (40)v18 Show 2 more changesShow less
    • Completion date: Aug 31, 2029 to Oct 10, 2030
    • Study sites revised (40)

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites revised (40)v17 See this version in full on ClinicalTrials.gov ↗
Show 15 earlier versionsHide 15 earlier versions
  1. Secondary endpoints: details revised at 2 of 37 entries Study sites revised (40) · Study title expanded, about 2 wordsv16 Show 2 more changesShow less
    • Study sites revised (40)
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites revised (40)v15 See this version in full on ClinicalTrials.gov ↗
  3. Primary completion date: Jan 1, 2027 to Dec 21, 2025 Completion date: Aug 1, 2030 to Aug 31, 2029 · Eligibility criteria expanded, about 73 words · Secondary endpoints: details revised at 4 of 37 entries · 1 morev14 Show 4 more changesShow less
    • Completion date: Aug 1, 2030 to Aug 31, 2029
    • Eligibility criteria expanded, about 73 words
    • Secondary endpoints: details revised at 4 of 37 entries
    • Study sites revised (40)

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites revised (40)v13 See this version in full on ClinicalTrials.gov ↗
  5. Study sites revised (40)v12 See this version in full on ClinicalTrials.gov ↗
  6. Study sites revised (40)v11 See this version in full on ClinicalTrials.gov ↗
  7. Study sites revised (40)v10 See this version in full on ClinicalTrials.gov ↗
  8. Study sites revised (40)v9 See this version in full on ClinicalTrials.gov ↗
  9. Study sites: 39 to 40v8
  10. Study sites: 36 to 39v7
  11. Study sites: 35 to 36v6
  12. Study sites: 34 to 35v5
  13. Study sites: 7 to 34v4
  14. Trial status: Not Yet Recruiting to Recruiting Study sites: 6 to 7 · Start date changed from estimate of Nov 3, 2023 to Nov 20, 2023v3 Show 2 more changesShow less
    • Study sites: 6 to 7
    • Start date changed from estimate of Nov 3, 2023 to Nov 20, 2023
  15. Start date: Sep 15, 2023 to Nov 3, 2023 Study sites: 1 to 6v2 Show 1 more changeShow less
    • Study sites: 1 to 6
  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.
The purpose of this study is to test the safety, tolerability, efficacy, and drug levels of BMS-986369 (Golcadomide) in participants with relapsed or refractory T-cell lymphomas in Japan (GOLSEEK-3).
Trial Details
NCT Number NCT06035497
Lead Sponsor Bristol-Myers Squibb
Conditions Relapsed or Refractory T-cell Lymphomas
Enrollment 83 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov