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A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma

Study acronym: OLYMPIA-5
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 3 months later Jan 23, 2029 → Apr 30, 2031
Primary endpoint reworded 1 of 4 changed
See other at-risk trials from Regeneron

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 6 of 21 entries
    • Study sites revised (171)
  2. Primary and study completion pushed from Jan 23, 2029 to Apr 30, 2031v44 Show 5 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 470 → 580 participants
    • Study sites: 169 to 171
    • Eligibility criteria revised
    • Secondary endpoints revised (21)
  3. Site details revised at 5 of 169 sitesv43
  4. Site details revised at 5 of 169 sitesv42
  5. Study sites: 168 to 169v41
Show 39 earlier versionsHide 39 earlier versions
  1. Study sites: 167 to 168v40
  2. Study sites: 166 to 167v39
  3. Study sites: 165 to 166v38 Show 4 more changesShow less
    • Secondary endpoints: 22 to 21
    • Primary endpoints revised (4)
    • Eligibility criteria expanded, about 2 words
    • Study title expanded, about 1 word
  4. Study sites: 163 to 165v37
  5. Study sites: 162 to 163v36
  6. Study sites: 160 to 162v35
  7. Study sites: 159 to 160v34
  8. Study sites: 158 to 159v33
  9. Study sites: 153 to 158v32
  10. Study sites: 152 to 153v31
  11. Study sites: 149 to 152v30
  12. Study sites: 148 to 149v29
  13. Study sites: 146 to 148v28
  14. Re-verified, no change to tracked fieldsv27
  15. Study sites: 144 to 146v26
  16. Study sites: 143 to 144v25
  17. Study sites: 142 to 143v24
  18. Study sites: 141 to 142v23
  19. Study sites: 131 to 141v22
  20. Study sites: 130 to 131v21
  21. Study sites: 129 to 130v20
  22. Study sites: 128 to 129v19
  23. Study sites: 124 to 128v18
  24. Study sites: 122 to 124v17
  25. Study sites: 118 to 122v16
  26. Study sites: 113 to 118v15
  27. Study sites: 109 to 113v14
  28. Study sites: 99 to 109v13
  29. Study sites: 93 to 99v12 Show 4 more changesShow less
    • Primary and study completion dates: Oct 4, 2029 to Jan 23, 2029
    • Eligibility criteria expanded, about 91 words
    • Secondary endpoints revised (22)
    • Study title expanded, about 1 word
  30. Study sites: 81 to 93v11
  31. Study sites: 66 to 81v10
  32. Study sites: 61 to 66v9
  33. Study sites: 53 to 61v8
  34. Study sites: 34 to 53v7
  35. Study sites: 16 to 34v6
  36. Study sites: 8 to 16v5
  37. Study sites: 3 to 8v4
  38. Study sites: 2 to 3
    • Primary and study completion dates: Jun 12, 2029 to Oct 4, 2029
    • Start date changed from estimate of Dec 18, 2023 to Dec 28, 2023
    v3
  39. Study sites: 1 to 2
    • Primary and study completion dates: May 31, 2029 to Jun 12, 2029
    • Start date: Dec 4, 2023 to Dec 18, 2023
    v2
  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 is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's Lymphoma (NHL). This study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before. The aim of Part 2, of the study is to assess how well the combination of the study drug and lenalidomide works compared to the combination of rituximab (called "the comparator drug") and lenalidomide. The combination of comparator drug and lenalidomide is the current standard-of-care treatment for relapsed/refractory FL and/or MZL. Standard-of-care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug in combination with lenalidomide * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * The impact from the study drug on quality-of-life and ability to complete routine daily activities
Trial Details
NCT Number NCT06149286
Lead Sponsor Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Relapsed/Refractory Follicular Lymphoma, Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL)
Related terms Lymphoma, B-Cell, Marginal Zone, Lymphoma, Follicular, Recurrence
Enrollment 580 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov