A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma

Study acronym: OLYMPIA-2
StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

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  1. Study sites: 144 to 145v35
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 145 to 144
    v34
  3. Site details revised at 51 of 145 sitesv33
  4. Study sites: 146 to 145v32
  5. Study sites: 144 to 146v31
Show 29 earlier versionsHide 29 earlier versions
  1. Re-verified, no change to tracked fieldsv30
  2. Study sites: 135 to 144v29
  3. Study sites: 123 to 135v28
  4. Study sites: 107 to 123v27
  5. Study sites: 95 to 107v26
  6. Study sites: 85 to 95v25
  7. Study sites: 75 to 85v24
  8. Study sites: 73 to 75v23
  9. Study sites revised (73)v22
  10. Study sites: 72 to 73v21
  11. Study sites: 71 to 72v20
  12. Study sites: 69 to 71v19
  13. Study sites: 68 to 69v18
  14. Study sites: 65 to 68v17
  15. Study sites: 62 to 65v16
  16. Study sites: 60 to 62v15
  17. Study sites: 58 to 60v14
  18. Study sites: 54 to 58v13
  19. Study sites: 49 to 54v12
  20. Primary and study completion dates: Jan 24, 2030 to Jul 29, 2029v11 Show 4 more changesShow less
    • Eligibility criteria shortened, about 7 words
    • Secondary endpoints revised (30)
    • Study sites revised (49)
    • Study title expanded, about 1 word
  21. Study sites: 35 to 49v10
  22. Study sites: 26 to 35v9
  23. Study sites: 20 to 26v8
  24. Study sites: 18 to 20v7
  25. Study sites: 11 to 18v6
  26. Study sites: 7 to 11v5
  27. Study sites: 3 to 7v4
  28. Start date changed from estimate of Nov 22, 2023 to Nov 14, 2023v3
  29. Study sites: 1 to 3
    • Primary and study completion dates: Jan 10, 2030 to Jan 24, 2030
    • Start date: Nov 8, 2023 to Nov 22, 2023
    v2
  1. Study First Submitted
  • 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. The study is focused on participants with previously untreated follicular lymphoma. Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. Participants with follicular lymphoma that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory") are eligible to take part only in Part 1A of the study. This study is made up of 3 parts: Part 1A (non-randomized), Part 1B and Part 2 (randomized - controlled). The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy to be used in Part 2 of the study. The aim of Part 2 of the study is to assess how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab and chemotherapy (the current standard-of-care for NHL). 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 * 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 NCT06097364
Lead Sponsor Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Follicular Lymphoma (FL)
Related terms Lymphoma, Follicular, Recurrence
Enrollment 733 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov