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

Part of paid clinical trials in Houston, Texas.

Sponsor
Ascentage Pharma Group Inc.
Study ID
NCT06641414
Phase
PHASE3
Status
Recruiting
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Conditions

  • Higher-risk Myelodysplastic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lisaftoclax (APG-2575) — DRUG
    QD, oral administration.
  • Azacitidine Injection — DRUG
    QD, hypodermic or intravenous injection.
  • Placebo — OTHER
    QD, oral administration.

Study Details

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.

Key Dates

Start date
Jan 22, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
490 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lisaftoclax (APG-2575) combined with Azacitidine
  • Active Comparator: Placebo combined with Azacitidine

Primary Outcome Measure

Overall Survival（OS） [ Time Frame: Up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77054
Guillermo Garcia-Manero, M.D.
[email protected]
713-745-3428
Guillermo Garcia-Manero, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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