Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

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.

Official Title

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).

Details

This study intends to enroll patients with HR-MDS to receive the therapy of lisaftoclax (APG-2575) combined with azacitidine (AZA) or placebo combined with azacitidine.

Keywords

Higher-risk Myelodysplastic Syndrome, Lisaftoclax, Azacitidine, Lisaftoclax (APG-2575), Azacitidine Injection

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Newly diagnosed higher-risk MDS.
  2. ECOG score of ≤2.
  3. Expected survival ≥ 3 months.
  4. Adequate organ function.
  5. 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.
  6. 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.
  7. Subjects are able to complete study procedures and follow-up examinations.

You CAN'T join if...

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

Locations

  • Ascentage Investigative Site accepting new patients
    Los Angeles California 90095 United States
  • Ascentage Investigative Site accepting new patients
    San Diego California 92093 United States
  • Ascentage Investigative Site accepting new patients
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ascentage Pharma Group Inc.
ID
NCT06641414
Phase
Phase 3 Myelodysplastic Syndrome Research Study
Study Type
Interventional
Participants
Expecting 490 study participants
Last Updated