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A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

Study acronym: InMIND
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 2 of 261 sitesv43
  2. 2 versions Re-verified since Jul 3, 2025, no change to tracked fieldsv41-v42
  3. Results first posted: Apr 4, 2025 Secondary endpoints: details revised at 2 of 34 entriesv40 Show 1 more changeShow less
    • Secondary endpoints: details revised at 2 of 34 entries
  4. Primary endpoints: 1 to 2 Secondary endpoints: 10 to 34v39 Show 1 more changeShow less
    • Secondary endpoints: 10 to 34

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv38
Show 36 earlier versionsHide 36 earlier versions
  1. Primary completion date changed from estimate of Aug 30, 2024 to Feb 23, 2024v37
  2. Re-verified, no change to tracked fieldsv36
  3. Primary completion date: Feb 1, 2024 to Aug 30, 2024 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 618 to confirmed 654 · Site details revised at 261 of 261 sitesv35 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 618 to confirmed 654
    • Site details revised at 261 of 261 sites
  4. Study sites revised (261)v34 See this version in full on ClinicalTrials.gov ↗
  5. Site details revised at 1 of 261 sitesv33
  6. Study sites revised (261)v32 See this version in full on ClinicalTrials.gov ↗
  7. Study sites revised (261)v31 See this version in full on ClinicalTrials.gov ↗
  8. Study sites: 256 to 261v30
  9. Study sites: 239 to 256v29
  10. Study sites revised (239)v28 See this version in full on ClinicalTrials.gov ↗
  11. Study sites: 238 to 239v27
  12. Study sites: 235 to 238v26
  13. Study sites: 233 to 235v25
  14. Site details revised at 4 of 233 sitesv24
  15. Study sites: 221 to 233v23
  16. Study sites: 220 to 221v22
  17. Study sites: 217 to 220v21
  18. Study sites: 211 to 217v20
  19. Study sites: 205 to 211 Start date: Apr 16, 2021 to Apr 15, 2021v19 Show 1 more changeShow less
    • Start date: Apr 16, 2021 to Apr 15, 2021
  20. Study sites: 202 to 205v18
  21. Study sites: 196 to 202v17
  22. Study sites: 183 to 196v16
  23. Study sites: 178 to 183v15
  24. Study sites: 173 to 178v14
  25. Study sites: 154 to 173v13
  26. Study sites: 147 to 154v12
  27. Study sites: 123 to 147v11
  28. Study sites: 65 to 123 Completion date: Aug 4, 2028 to Aug 9, 2028v10 Show 1 more changeShow less
    • Completion date: Aug 4, 2028 to Aug 9, 2028
  29. Study sites: 33 to 65 Primary completion date: Jan 27, 2024 to Feb 1, 2024v9 Show 1 more changeShow less
    • Primary completion date: Jan 27, 2024 to Feb 1, 2024
  30. Study sites: 30 to 33v8
  31. Study sites: 28 to 30 Study description shortened, about 3 wordsv7 Show 1 more changeShow less
    • Study description shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  32. Study description expanded, about 3 wordsv6 See this version in full on ClinicalTrials.gov ↗
  33. Primary completion date: Jun 30, 2023 to Jan 27, 2024 Study sites: 8 to 28 · Completion date: Feb 24, 2029 to Aug 4, 2028v5 Show 2 more changesShow less
    • Study sites: 8 to 28
    • Completion date: Feb 24, 2029 to Aug 4, 2028
  34. Start date changed from estimate of Mar 31, 2021 to Apr 16, 2021v4
  35. Study sites: 1 to 8v3
  36. Trial status: Not Yet Recruiting to Recruiting Start date: Jan 30, 2021 to Mar 31, 2021 · Study sites: 0 to 1 · Completion date: Feb 15, 2029 to Feb 24, 2029v2 Show 3 more changesShow less
    • Start date: Jan 30, 2021 to Mar 31, 2021
    • Study sites: 0 to 1
    • Completion date: Feb 15, 2029 to Feb 24, 2029
  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.
Incyte
94 trials monitored
See 9 trials at risk
Follicular Lymphoma
313 trials monitored
See 26 trials at risk
This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.
Trial Details
NCT Number NCT04680052
Lead Sponsor Incyte Corporation
Conditions Follicular Lymphoma, Marginal Zone Lymphoma
Enrollment 654 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov