Combining Lisaftoclax with Azacitidine for treating higher-risk Myelodysplastic Syndrome

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).

This study is testing if combining Lisaftoclax with azacitidine can help people newly diagnosed with higher-risk Myelodysplastic Syndrome live longer compared to just using azacitidine with a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 490 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ascentage Pharma Group Inc. (Industry-sponsored)
• Locations: 2 sites (Houston, Texas and 1 other locations)
• Trial ID: NCT06641414 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are newly diagnosed patients with higher-risk Myelodysplastic Syndrome and an ECOG score of 2 or less.

Not a fit: Patients with uncontrolled active infections or those who have undergone hematopoietic stem cell transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve overall survival rates for patients with higher-risk Myelodysplastic Syndrome.

How similar studies have performed: Other studies have shown promise with similar combination therapies, indicating potential for success in this approach.

Eligibility criteria

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. Uncontrolled active infection
4. Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 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.

Where this trial is running

Houston, Texas and 1 other locations

• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yifan Zhai, M.D., Ph.D.

Conditions Higher-risk Myelodysplastic Syndrome; Lisaftoclax