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 Greece

Study acronym: SURVIVE
StatusCompleted
PhaseNot specified
SponsorAbbVie
Started

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Record History

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  1. Minor Trial completed Show 5 more changesShow less
    • Primary completion date changed from estimate of Dec 2026 to May 29, 2026
    • Enrollment target: estimated 100 to confirmed 106
    • Secondary endpoints: details revised at 2 of 14 entries
    • Site details revised at 13 of 13 sites
    • Eligibility criteria expanded, about 2 words
  2. Minor Primary and study completion dates: Dec 31, 2026 to Dec 2026v21
  3. Minor Re-verified, no change to tracked fieldsv20
  4. Minor Study sites: 12 to 13v19
  5. Minor Site details revised at 10 of 12 sitesv18
Show 16 earlier versionsHide 16 earlier versions
  1. Minor Study sites revised (12)v17
  2. Minor 3 versions Re-verified since Mar 1, 2023, no change to tracked fieldsv14-v16
  3. Notable Primary completion date: May 30, 2026 to Dec 31, 2026v13
  4. Minor Primary completion date: Dec 31, 2026 to May 30, 2026v12
  5. Notable Primary completion date: May 30, 2026 to Dec 31, 2026v11
  6. Minor Primary completion date: Dec 31, 2026 to May 30, 2026v10
  7. Notable Primary completion date: May 30, 2026 to Dec 31, 2026
    • Study sites: 11 to 12
    v9
  8. Minor Site details revised at 1 of 11 sitesv8
  9. Minor Study sites: 10 to 11v7
  10. Minor Study sites: 9 to 10v6
  11. Minor Study sites: 8 to 9v5
  12. Minor Study sites: 5 to 8v4
  13. Minor Study sites: 4 to 5
    • Study completion date: May 30, 2026 to Dec 31, 2026
    v3
  14. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Primary and study completion dates: Apr 30, 2026 to May 30, 2026
    • Start date changed from estimate of May 3, 2022 to May 26, 2022
    v2
  1. Minor Study First Submitted
  • 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.
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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 chemotherapy in Greece. Venetoclax is a drug approved to treat Acute Myeloid Leukemia. 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 chemotherapy will be enrolled. Around 100 participants will be enrolled in the study in approximately 15 sites in Greece. Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 30 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 30 months.
Trial Details
NCT Number NCT05317494
Lead Sponsor AbbVie
Conditions
(from sponsor)
Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute, Neoplasms
Enrollment 106 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov