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

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 ID
NCT06389292
Phase
PHASE3
Sponsor
Ascentage Pharma Group Inc.
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • APG-2575(Lisaftoclax )
  • Placebo
  • Azacitidine Injection
Locations (sample)
  • Tianjin, Tianjin Municipality, China|39.14222,117.17667
  • Hangzhou, Zhejiang, China|30.29365,120.16142
  • Moscow, Russia|55.75204,37.61781
  • Moscow, Russia|55.75204,37.61781
  • Saint Petersburg, Russia|59.93863,30.31413

Key Eligibility Criteria

  • Patients must have newly diagnosed AML that meets the criteria for acute myeloid leukemia (AML) and ineligible for standard chemotherapy.
  • Life expectancy of ≥3 months.
  • Be able to accept oral administration.
  • Patients aged ≥70 years with ECOG score of 0-2, or those aged≥18 years and \<70 years with ECOG score of 0-3.

For full eligibility, visit ClinicalTrials.gov.

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