Combining Lisaftoclax with Azacitidine for treating higher-risk Myelodysplastic Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III clinical trial evaluates the effectiveness of Lisaftoclax (APG-2575) in combination with azacitidine (AZA) compared to a placebo with azacitidine in patients newly diagnosed with higher-risk Myelodysplastic Syndrome (HR-MDS). The study is a global multicenter, randomized, double-blind, placebo-controlled trial aimed at assessing overall survival outcomes. Participants will receive either the active treatment or placebo while being monitored for their response to the therapy. The trial seeks to provide insights into the potential benefits of this combination therapy for improving patient outcomes.

Why it matters

Who can join: the full rules

Inclusion 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.

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.

Where it's running

• Ascentage Investigative Site
  Phoenix, Arizona, United States Recruiting
• Ascentage Investigative Site
  Los Angeles, California, United States Recruiting
• Ascentage Investigative Site
  Sacramento, California, United States Recruiting
• Ascentage Investigative Site
  San Diego, California, United States Recruiting
• Ascentage Investigative Site
  Aurora, Colorado, United States Recruiting
• Ascentage Investigative Site
  Jacksonville, Florida, United States Recruiting

+105 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Yifan Zhai, M.D., Ph.D.
• Email: yzhai@ascentage.com
• Phone: +86-20-28068501

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.