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A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 26 wordsv5 See this version in full on ClinicalTrials.gov ↗
  2. Study sites: 2 to 6 Interventions: Azacitidine Injection (Drug), Lisaftoclax (APG-2575) (Drug), Placebo (Other) to APG-2575(Lisaftoclax ) (Drug), Azacitidine Injection (Drug), Placebo (Other) · Eligibility criteria revised · Study description expanded, about 2 wordsv4 Show 3 more changesShow less
    • Interventions: Azacitidine Injection (Drug), Lisaftoclax (APG-2575) (Drug), Placebo (Other) to APG-2575(Lisaftoclax ) (Drug), Azacitidine Injection (Drug), Placebo (Other)
    • Eligibility criteria revised
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study title revisedv3 See this version in full on ClinicalTrials.gov ↗
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of May 2024 to Jun 11, 2024 · Site details revised at 2 of 2 sites · Study title shortened, about 2 wordsv2 Show 3 more changesShow less
    • Start date changed from estimate of May 2024 to Jun 11, 2024
    • Site details revised at 2 of 2 sites
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A global, multicenter, randomized, double-blind, placebo-controlled, phase III pivotal registration study, to evaluate the efficacy of APG-2575 (Lisaftoclax) combined with azacitidine (AZA) versus placebo combined with azacitidine in newly diagnosed acute myeloid leukemia who are not eligible for standard induction chemotherapy.
Trial Details
NCT Number NCT06389292
Lead Sponsor Ascentage Pharma Group Inc.
Conditions Acute Myeloid Leukemia
Enrollment 486 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov