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A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 2 of 4 entries Trial sites expanded: 228 → 235 locations · Eligibility criteria expanded, about 15 words · Study description expanded, about 5 words Show 3 more changesShow less
    • Trial sites expanded: 228 → 235 locations
    • Eligibility criteria expanded, about 15 words
    • Study description expanded, about 5 words
  2. Trial sites expanded: 224 → 228 locationsv23
  3. Trial sites expanded: 214 → 224 locationsv22
  4. Trial sites expanded: 193 → 214 locationsv21
  5. Trial sites expanded: 159 → 193 locationsv20
  6. Trial sites expanded: 135 → 159 locationsv19
  7. Enrollment target: 1015 to 1018 Study sites: 131 to 135v18 Show 1 more changeShow less
    • Study sites: 131 to 135
  8. Study sites: 128 to 131v17
  9. Primary endpoints revised (4) Study sites: 121 to 128 · Interventions: AZD0486 (Drug), BR (Drug), R-CHOP (Drug), R-CVP (Drug) to BR (Drug), R-CHOP (Drug), R-CVP (Drug), Surovatamig (Drug) · Eligibility criteria expanded, about 104 words · 3 morev16 Show 6 more changesShow less
    • Study sites: 121 to 128
    • Interventions: AZD0486 (Drug), BR (Drug), R-CHOP (Drug), R-CVP (Drug) to BR (Drug), R-CHOP (Drug), R-CVP (Drug), Surovatamig (Drug)
    • Eligibility criteria expanded, about 104 words
    • Secondary endpoints: details revised at 4 of 9 entries
    • Study description expanded, about 2 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  10. Site details revised at 6 of 121 sitesv15
  11. Study sites: 117 to 121v14
  12. Study sites: 115 to 117v13
  13. Study sites: 97 to 115v12
  14. Primary endpoints: 3 to 4 Study sites: 63 to 97 · Eligibility criteria expanded, about 17 words · Secondary endpoints: 7 to 9 · 1 morev11 Show 4 more changesShow less
    • Study sites: 63 to 97
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: 7 to 9
    • Study description expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 54 to 63v10
  16. Primary completion date: Apr 15, 2031 to Nov 26, 2031 Study sites: 45 to 54 · Completion date: Feb 28, 2035 to Nov 26, 2031v9 Show 2 more changesShow less
    • Study sites: 45 to 54
    • Completion date: Feb 28, 2035 to Nov 26, 2031
  17. Site details revised at 1 of 45 sitesv8
  18. Study sites: 44 to 45v7
  19. Site details revised at 3 of 44 sitesv6
  20. Enrollment target: 1005 to 1015 Site details revised at 6 of 44 sitesv5 Show 1 more changeShow less
    • Site details revised at 6 of 44 sites
  21. Study sites: 43 to 44v4
  22. Study sites: 39 to 43 Primary completion date: Apr 16, 2031 to Apr 15, 2031 · Completion date: Mar 1, 2035 to Feb 28, 2035v3 Show 2 more changesShow less
    • Primary completion date: Apr 16, 2031 to Apr 15, 2031
    • Completion date: Mar 1, 2035 to Feb 28, 2035
  23. Trial status: Not Yet Recruiting to Recruiting Primary endpoints revised (3) · Study sites: 37 to 39 · Primary completion date: Apr 18, 2031 to Apr 16, 2031 · 2 morev2 Show 5 more changesShow less
    • Primary endpoints revised (3)
    • Study sites: 37 to 39
    • Primary completion date: Apr 18, 2031 to Apr 16, 2031
    • Completion date: Mar 5, 2035 to Mar 1, 2035
    • Start date changed from estimate of Aug 9, 2024 to Aug 7, 2024

    See this version in full on ClinicalTrials.gov ↗

  24. 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 is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the Surovatamig (AZD0486) plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL.
Trial Details
NCT Number NCT06549595
Lead Sponsor AstraZeneca
Conditions Untreated Follicular Lymphoma
Enrollment 1,018 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov