A Study to Asses Effectiveness and Treatment Management of Oral Venetoclax Tablets + Subcutaneously Injected Azacitidine in Adult Participants Ineligible for Intensive Chemotherapy With de Novo Acute Myeloid Leukemia (AML) in Italy

Study acronym: VERO
StatusCompleted
PhaseNot specified
SponsorAbbVie
Started

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Record History

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  1. Trial completed Show 4 more changesShow less
    • Primary completion date changed from estimate of Nov 2026 to Jul 21, 2026
    • Enrollment target: estimated 150 to confirmed 151
    • Eligibility criteria expanded, about 6 words
    • Study sites revised (28)
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 27 to 28
    v18
  3. Study sites: 26 to 27
    • Primary and study completion dates: Nov 30, 2026 to Nov 2026
    v17
  4. Study sites: 22 to 26v16
  5. Study sites: 20 to 22v15
Show 13 earlier versionsHide 13 earlier versions
  1. Study sites revised (20)v14
  2. Re-verified, no change to tracked fieldsv13
  3. Study sites: 18 to 20v12
  4. Study sites: 16 to 18v11
  5. Re-verified, no change to tracked fieldsv10
  6. Site details revised at 1 of 16 sitesv9
  7. Study sites: 15 to 16v8
  8. Study sites: 11 to 15v7
  9. Study sites: 10 to 11v6
  10. Study sites revised (10)v5
  11. Primary completion date: Mar 31, 2026 to Nov 30, 2026
    • Study sites: 3 to 10
    v4
  12. Study sites: 1 to 3
    • Study completion date: Mar 31, 2026 to Nov 30, 2026
    • Start date: Mar 5, 2024 to Mar 4, 2024
    v3
  13. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 31, 2023 to Mar 5, 2024
    v2
  1. 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.
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 in combination with azacitidine works to treat AML in newly diagnosed adult participants who are ineligible for intensive chemotherapy in Italy. Venetoclax in combination with azacitidine is approved in Italy to treat Acute myeloid leukemia (AML) in newly diagnosed adults who are ineligible for intensive chemotherapy. All study participants will receive venetoclax in combination with azacitidine as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML will be enrolled. Around 150 participants will be enrolled in the study at approximately 20-25 sites in Italy. Participants will receive venetoclax tablets to be taken by mouth in combination with azacitidine given by subcutaneous (SC) injection according to the approved local label. The duration of the study is approximately 18 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 18 months.
Trial Details
NCT Number NCT06058741
Lead Sponsor AbbVie
Conditions
(from sponsor)		 Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute, Neoplasms
Enrollment 151 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov