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RecruitingPhase 3NCT06641414

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

A Global Multicenter, Double-blind, Randomized, Registrational Phase 3 Study of Lisaftoclax (APG-2575) in Combination With Azacitidine (AZA) in Patients With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (GLORA-4).

Sponsor

Ascentage Pharma Group Inc.

Enrollment

490 participants

Start Date

Jan 22, 2025

Study Type

INTERVENTIONAL

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • Newly diagnosed higher-risk MDS.
  • ECOG score of ≤2.
  • Expected survival ≥ 3 months.
  • Adequate organ function.
  • Female subjects of potential childbearing potential have a negative urine or serum pregnancy test before dosing. Subjects of childbearing potential as well as their partners voluntarily use contraception deemed effective by the investigator during the treatment period and for at least six months after the last dose of study drug.
  • Able to understand and voluntarily sign a written informed consent form, which must be signed prior to the performance of any trial-specified study procedures.
  • Subjects are able to complete study procedures and follow-up examinations.

Exclusion Criteria6

  • Concomitant other malignancies or prior malignancies with disease-free intervals of less than 1 year at the time of signing the informed consent.
  • Have undergone hematopoietic stem cell transplantation.
  • Uncontrolled active infection
  • Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 days prior to the first dose of study drug.
  • MDS or other conditions that cannot be administered enterally.
  • Any condition that the subject is deemed to be inappropriate to participate in this study after evaluation by the investigator.

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Interventions

DRUGLisaftoclax (APG-2575)

QD, oral administration.

DRUGAzacitidine Injection

QD, hypodermic or intravenous injection.

OTHERPlacebo

QD, oral administration.

Locations(2)

MD Anderson Cancer Center

Houston, Texas, United States

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT06641414