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Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 1 of 2 sitesv5
  2. Eligibility criteria revisedv4 See this version in full on ClinicalTrials.gov ↗
  3. Enrollment target: 464 to 490v3
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 2024 to Jan 22, 2025 · Site details revised at 2 of 2 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Oct 2024 to Jan 22, 2025
    • Site details revised at 2 of 2 sites
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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, pivotal phase III study. To evaluate overall survival (OS) of Lisaftoclax (APG-2575) combined with azacitidine (AZA) vs. placebo combined with azacitidine in newly diagnosed patients with HR-MDS.
Trial Details
NCT Number NCT06641414
Lead Sponsor Ascentage Pharma Group Inc.
Conditions Higher-risk Myelodysplastic Syndrome
Enrollment 490 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov