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

Description

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

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Study Overview

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Study Details

Study overview

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.

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).

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

Condition
Higher-risk Myelodysplastic Syndrome
Intervention / Treatment

-

Contacts and Locations

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.
  • 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. Uncontrolled active infection
  • 4. Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 7 days prior to the first dose of study drug.
  • 5. MDS or other conditions that cannot be administered enterally.
  • 6. Any condition that the subject is deemed to be inappropriate to participate in this study after evaluation by the investigator.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ascentage Pharma Group Inc.,

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

Guillermo Garcia-Manero, M.D., STUDY_CHAIR, M.D. Anderson Cancer Center

Study Record Dates

2029-12