A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Canada

Study acronym: LIVEN
StatusTerminated
PhaseNot specified
SponsorAbbVie
Started

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Record History

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  1. Trial terminated Sponsor's reason: Strategic Considerations Show 4 more changesShow less
    • Primary completion date changed from estimate of Mar 2027 to Aug 31, 2026
    • Secondary endpoints: details revised at 1 of 11 entries
    • Site details revised at 20 of 20 sites
    • Eligibility criteria expanded, about 3 words
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 270 to confirmed 210
    • Primary and study completion dates: Mar 31, 2027 to Mar 2027
    • Study sites revised (20)
    v23
  3. Primary and study completion dates: Jun 30, 2026 to Mar 31, 2027v22
  4. 2 versions Re-verified since May 21, 2024, no change to tracked fieldsv20-v21
  5. Study sites: 19 to 20v19
Show 17 earlier versionsHide 17 earlier versions
  1. Study sites: 17 to 19v18
  2. Site contacts updated at 1 of 17 sitesv17
  3. Study sites: 16 to 17v16
  4. Study sites: 15 to 16v15
  5. Study sites: 12 to 15v14
  6. Study sites: 10 to 12v13
  7. 2 versions Re-verified since Jun 14, 2023, no change to tracked fieldsv11-v12
  8. Study sites: 19 to 10v10
  9. Re-verified, no change to tracked fieldsv9
  10. Site details revised at 2 of 19 sitesv8
  11. Study sites: 17 to 19
    • Start date: Sep 12, 2022 to Sep 7, 2022
    v7
  12. Re-verified, no change to tracked fieldsv6
  13. Study sites: 15 to 17v5
  14. Study sites: 14 to 15
    • Start date: Sep 7, 2022 to Sep 12, 2022
    v4
  15. Study sites: 13 to 14
    • Start date changed from estimate of Aug 31, 2022 to Sep 7, 2022
    v3
  16. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jun 30, 2022 to Aug 31, 2022
    • Study sites: 10 to 13
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
AbbVie
349 trials monitored
See 27 trials at risk
Leukemia
2,957 trials monitored
See 176 trials at risk
Acute Myeloid Leukemia (AML)
1,275 trials monitored
See 74 trials at risk
Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well venetoclax works to treat AML in adult participants who are ineligible for intensive induction chemotherapy in Canada. Venetoclax is a drug approved to treat Acute Myeloid Leukemia (AML). All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML who are ineligible for intensive induction chemotherapy will be enrolled. Around 200 participants will be enrolled in the study in approximately 15-20 sites in Canada. Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 36 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 36 months.
Trial Details
NCT Number NCT05424562
Lead Sponsor AbbVie
Conditions
(from sponsor)		 Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute, Neoplasms
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov