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

RecruitingPhase 3Ages 18 Years - anyAllAscentage Pharma Group Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Newly diagnosed higher-risk MDS. 2. ECOG score of โ‰ค2. 3. Expected survival โ‰ฅ 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. Exclusion Criteria: 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.
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What it tests

  • Lisaftoclax (APG-2575)
  • Azacitidine Injection
  • Placebo
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Where

155 sites
Ascentage Investigative Site
Birmingham, United States
Ascentage Investigative Site
Phoenix, United States
Ascentage Investigative Site
Los Angeles, United States
Ascentage Investigative Site
Sacramento, United States
Ascentage Investigative Site
San Diego, United States
Ascentage Investigative Site
Aurora, United States
Ascentage Investigative Site
Jacksonville, United States
Ascentage Investigative Site
Chicago, United States

โ€ฆand 147 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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