Study to Assess Adverse Events and Change in Disease State of Oral Venetoclax in Combination With Subcutaneous (SC) Azacitidine in Newly Diagnosed Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy in China

StatusActive, Not Recruiting
PhasePhase 4
SponsorAbbVie
Started

Record status This record was last updated August 12, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Notable Primary and study completion dates: Apr 2025 to Mar 2026v21
  2. Re-verified, no change to tracked fieldsv20
  3. Notable Primary and study completion dates: Jul 28, 2024 to Apr 2025
    • Site details revised at 1 of 18 sites
    v19
  4. Minor Study sites revised (18)v18
  5. Minor Study sites: 21 to 18
    • Primary and study completion dates: Jul 26, 2024 to Jul 28, 2024
    v17
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  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 40 to confirmed 44
    • Site details revised at 21 of 21 sites
    v16
  2. Minor Study sites: 24 to 21
    • Eligibility criteria revised
    v15
  3. Minor Site details revised at 1 of 24 sitesv14
  4. Minor Site details revised at 1 of 24 sitesv13
  5. Minor Site details revised at 1 of 24 sitesv12
  6. Minor Site details revised at 1 of 24 sitesv11
  7. Minor Site details revised at 1 of 24 sitesv10
  8. Minor Site details revised at 1 of 24 sitesv9
  9. Minor Site details revised at 1 of 24 sitesv8
  10. Minor Eligibility criteria shortened, about 117 words
    • Site details revised at 2 of 24 sites
    v7
  11. Minor Site details revised at 5 of 24 sitesv6
  12. Minor Study sites: 26 to 24v5
  13. Minor Site details revised at 2 of 26 sitesv4
  14. Minor Site details revised at 2 of 26 sitesv3
  15. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 20, 2021 to Jan 6, 2022
    • Site details revised at 26 of 26 sites
    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.
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Acute myeloid leukemia (AML) is one of the most aggressive blood cancers, with a very low survival rate and few options for participants who are unable to undergo intensive chemotherapy, the current standard of care. This study is to evaluate how safe the combination of azacitidine and venetoclax is and how effective the combination of azacitidine and venetoclax is in adult participants with acute myeloid leukemia (AML), in China. Adverse events and change in disease state will be assessed. The combination of azacitidine and venetoclax is being evaluated in the treatment of acute myeloid leukemia (AML). Participants will receive azacitidine with increasing doses of venetoclax. Adult participants with a diagnosis of AML will be enrolled. Around 40 participants will be enrolled in the study in approximately 30 sites in China. At cycle 1 during ramp-up period, participants will receive venetoclax oral tablets once daily in increasing doses until the study dose is achieved on day 3. Then ventoclax oral tablets will continue once daily thereafter. Azacitidine will be given by subcutaneous injection (SC) for 7 days beginning on Day 1 of each 28-day cycle. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.
Trial Details
NCT Number NCT05144243
Lead Sponsor AbbVie
Collaborators: Genentech, Inc.
Conditions
(from sponsor)
Acute Myeloid Leukemia (AML)
Related terms Leukemia, Myeloid, Acute
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov