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

NCT06641414 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 490

Last updated 2025-11-20

No results posted yet for this study

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.

Conditions

  • Higher-risk Myelodysplastic Syndrome

Interventions

DRUG

Lisaftoclax (APG-2575)

QD, oral administration.

DRUG

Azacitidine Injection

QD, hypodermic or intravenous injection.

OTHER

Placebo

QD, oral administration.

Sponsors & Collaborators

  • Ascentage Pharma Group Inc.

    lead INDUSTRY

Principal Investigators

  • Xiaojun Huang, M.D., Ph.D. · Peking University People's Hospital

  • Guillermo Garcia-Manero, M.D. · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-22
Primary Completion
2029-06-30
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06641414 on ClinicalTrials.gov