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NCT02966756

A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

StatusActive, Not Recruiting
PhasePhase 2
SponsorAbbVie
Primary completion (estimated)

At risk: Primary completion moved at least 1 year 6 months later, enrollment reduced 40%.

See at-risk trials from AbbVie

Track this trial

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Record History

All 36 versions: 34 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 110 → 66 participants
    • Primary and study completion pushed from May 2029 to Dec 2030
    • Enrollment closed, study ongoing
    • Study sites revised (31)
    v36
  2. Study sites revised (31)v35
  3. Eligibility criteria expanded, about 4 words
    • Primary and study completion dates: May 30, 2029 to May 2029
    • Study sites revised (31)
    v34
  4. Site details revised at 9 of 31 sitesv33
  5. Site details revised at 9 of 31 sitesv32
Show 28 earlier versionsHide 28 earlier versions
  1. Primary completion date: May 31, 2026 to May 30, 2029
    • Site details revised at 1 of 31 sites
    v31
  2. Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 2 of 7 entries
    • Site details revised at 1 of 31 sites
    v30
  3. Primary completion date: May 31, 2024 to May 31, 2026v29 Show 4 more changesShow less
    • Eligibility criteria shortened, about 2 words
    • Study completion date: Nov 15, 2024 to May 30, 2029
    • Secondary endpoints: 8 to 7
    • Study sites revised (31)
  4. Study completion date: Sep 28, 2026 to Nov 15, 2024
    • Study sites revised (31)
    v26
  5. Enrollment target: 70 to 110v25 Show 5 more changesShow less
    • Eligibility criteria expanded, about 68 words
    • Secondary endpoints revised (8)
    • Study sites revised (31)
    • Study title shortened, about 6 words
    • Study arms: 1 to 2
  6. Site details revised at 1 of 31 sitesv24
  7. Primary completion date: Aug 29, 2021 to May 31, 2024v23 Show 5 more changesShow less
    • Eligibility criteria expanded, about 6 words
    • Study completion date: Apr 29, 2025 to Sep 28, 2026
    • Secondary endpoints revised (8)
    • Study sites revised (31)
    • Study title expanded, about 2 words
  8. Primary completion date: Dec 28, 2021 to Aug 29, 2021
    • Study completion date: Dec 29, 2024 to Apr 29, 2025
    • Study sites revised (31)
    v22
  9. Study sites: 32 to 31
    • Primary completion date: Aug 29, 2021 to Dec 28, 2021
    • Study completion date: Aug 28, 2024 to Dec 29, 2024
    v21
  10. Site details revised at 2 of 32 sitesv20
  11. Site details revised at 10 of 32 sitesv19
  12. Study sites: 31 to 32
    • Study completion date: Aug 25, 2024 to Aug 28, 2024
    • Study title expanded, about 1 word
    v18
  13. Study sites: 29 to 31
    • Primary completion date: Jun 18, 2021 to Aug 29, 2021
    • Study title revised
    v17
  14. Study sites: 30 to 29
    • Primary completion date: Aug 29, 2021 to Jun 18, 2021
    v16
  15. Study sites revised (30)v15
  16. Study sites revised (30)
    • Collaborators shortened, about 1 word
    v14
  17. Study sites: 27 to 30
    • Secondary endpoints revised (8)
    v13
  18. Primary completion date: Jun 18, 2021 to Aug 29, 2021
    • Study sites revised (27)
    v12
  19. Study sites: 25 to 27
    • Study title revised
    v11
  20. Study sites: 23 to 25
    • Study title shortened, about 1 word
    v10
  21. Study sites: 20 to 23
    • Study completion date: Aug 28, 2024 to Aug 25, 2024
    • Study title expanded, about 1 word
    v9
  22. Site details revised at 1 of 20 sitesv8
  23. Study sites: 10 to 20
    • Secondary endpoints reordered
    v7
  24. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 5, 2017 to Oct 12, 2017
    • Site details revised at 10 of 10 sites
    v6
  25. Start date: Jun 30, 2017 to Oct 5, 2017
    • Eligibility criteria shortened, about 8 words
    • Study sites: 0 to 10
    • Study completion date: Jul 23, 2024 to Aug 28, 2024
    v5
  26. Start date: May 2017 to Jun 30, 2017
    • Eligibility criteria expanded, about 1 word
    • Primary completion date: Jun 2021 to Jun 18, 2021
    • Study completion date: Jun 2024 to Jul 23, 2024
    v4
  27. Eligibility criteria expanded, about 10 words
    • Study completion date: May 2024 to Jun 2024
    • Start date: Apr 2017 to May 2017
    • Secondary endpoints: details revised at 4 of 8 entries
    v3
  28. Primary completion date: Jun 2019 to Jun 2021
    • Start date: May 2017 to Apr 2017
    • Collaborators expanded, about 1 word
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Overall Response Rate (ORR)
Timeframe: Measured up to 2 years after the last participant has enrolled in the study.

Secondary (7)

Complete Response Rate (CRR)
Duration of Overall Response (DOR)
Progression Free Survival (PFS)
Event Free Survival (EFS)
Time to Progression (TTP)
Show 2 moreShow less
Time to 50% reduction in absolute lymphocyte count (ALC)
Overall Survival (OS)

Arms and interventions

Cohort 1: VenetoclaxExperimental

Participants with 17p deletion status will receive various doses of venetoclax once daily (QD).

Cohort 2: VenetoclaxExperimental

Participants who have failed a B-Cell Receptor Signaling Pathway Inhibitor (BCRI) therapy and who have also failed, or were unable to receive chemoimmunotherapy (CIT) irrespective of 17p status will receive various doses of venetoclax once daily (QD).

Drugs: Venetoclax

Sites

31 sites in 4 countries

China 21, Taiwan 5, Australia 3, New Zealand 2