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ReVenGNCT04895436

Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)

StatusRecruiting
PhasePhase 2
SponsorAbbVie
Primary completion (estimated)
Track this trial

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Record History

The 50 most recent of 94 versions: 41 with changes below, 9 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Study sites: 57 to 58v94
  2. Study sites revised (57)v93
  3. Site details revised at 1 of 57 sitesv92
  4. Study sites: 56 to 57v91
  5. Study sites revised (56)v90
Show 36 earlier versionsHide 36 earlier versions
  1. Study sites: 55 to 56v89
  2. Study sites revised (55)v88
  3. Study sites: 54 to 55v87
  4. Study sites: 53 to 54v86
  5. Site details revised at 1 of 53 sitesv85
  6. Study sites: 52 to 53v84
  7. Study sites revised (52)v83
  8. Site details revised at 1 of 52 sitesv82
  9. Site details revised at 1 of 52 sitesv81
  10. Study sites: 51 to 52v80
  11. Study sites: 50 to 51v79
  12. Primary completion date: Feb 22, 2025 to Nov 2026
    • Study completion date: Jan 28, 2029 to Jan 2029
    v76
  13. Study sites: 49 to 50v75
  14. Primary completion date: Nov 28, 2026 to Feb 22, 2025
    • Site details revised at 7 of 49 sites
    v74
  15. Primary completion date: Feb 22, 2025 to Nov 28, 2026
    • Study sites revised (49)
    v73
  16. Site details revised at 2 of 49 sitesv72
  17. Study sites: 48 to 49v69
  18. Study completion date: Jul 23, 2027 to Jan 28, 2029
    • Study sites revised (48)
    v68
  19. Study completion date: Jan 28, 2029 to Jul 23, 2027
    • Study sites revised (48)
    v67
  20. Study completion date: Jun 11, 2026 to Jan 28, 2029
    • Study sites revised (48)
    v66
  21. Study sites: 47 to 48v65
  22. Study sites: 45 to 47v64
  23. Study sites: 44 to 45v63
  24. Site details revised at 1 of 44 sitesv62
  25. Site details revised at 1 of 44 sitesv61
  26. Study sites: 43 to 44v59
  27. Study sites: 42 to 43v57
  28. Site details revised at 2 of 42 sitesv56
  29. Study sites: 41 to 42v55
  30. Study sites: 40 to 41v52
  31. Study sites: 39 to 40v50
  32. Site details revised at 1 of 39 sitesv49
  33. Eligibility criteria expanded, about 9 wordsv48 Show 4 more changesShow less
    • Primary endpoint revised
    • Study sites: 53 to 39
    • Primary completion date: Dec 31, 2024 to Feb 22, 2025
    • Secondary endpoints: 10 to 9
  34. Study sites revised (53)v47
  35. Site details revised at 3 of 53 sitesv46
  36. Site details revised at 1 of 53 sitesv45
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Overall response (OR) in Cohort 1 after end of combination treatment
Timeframe: 9 months

Secondary (9)

OR in Cohort 1 after end of combination treatment
OR in Cohort 1 after end of treatment
Time to Response (TTR) in Cohort 1
Duration of Response (DOR) in Cohort 1
Time to Next Treatment (TTNT) for CLL in Cohort 1
Show 4 moreShow less
Progression-free Survival (PFS) in Cohort 1
Overall Survival (OS) in Cohort 1
Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of combination treatment
Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of treatment

Arms and interventions

Cohort 1 - venetoclax + obinutuzumabExperimental

Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for six 28-day cycles.

Cohort 2 - venetoclax + obinutuzumabExperimental

Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for eighteen 28-day cycles.

Drugs: Venetoclax, Obinutuzumab

Sites

58 sites in 11 countries

Germany 17, United States 15, Austria 7, Israel 4, Australia 3, Brazil 3, United Kingdom 3, Bulgaria 2, Italy 2, Romania 1, Spain 1