Clinical Trials | 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)

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) that are not scheduled for hematopoietic stem cell transplantation (HSCT), or that are not eligible for HSCT. The purpose of this study is to evaluate the efficacy and safety difference of lisaftoclax in combination with azacitidine (AZA) compared to a matching placebo of lisaftoclax in combination with AZA. Placebo is a treatment with no active drug ingredients. In this study, there is a 50/50 chance (purely by chance, like tossing a coin) you will be enrolled in the investigational group or control group. Patients assigned to the investigational group will receive lisaftoclax in combination with AZA. Lisaftoclax is considered an investigational drug per your local regulatory authorities. An investigational drug means it is not approved by your local regulatory authority. Control group patients will receive placebo plus AZA. Placebo refers to the lisaftoclax mock drug without the active drug. This study is double-blind, which means that neither you, site personnel, nor any researcher will know if you are being treated with lisaftoclax plus AZA or placebo plus AZA. The current standard of care is AZA only for HR-MDS. This is what you will be guaranteed to receive whether you are randomized into the investigational group or control group. Taking part in this study may have some risks and discomforts. The study drug(s) or test(s) may make you feel unwell or uncomfortable or could harm you. There may also be risks involved in taking the study drug that have not yet been discovered. You may or may not benefit as a result of your participation in this study. However, this study may also help doctors learn things that can help other people in the future. After starting study drug therapy, you will be followed on a cycle of 28 days (4 weeks) and you will need to visit the study centre approximately 5-6 times during Cycle 1; Starting in Cycle 2, you will need to visit the study centre approximately 3-4 times per cycle for safety follow-up and a comprehensive assessment of your disease. After Cycle 12, you will visit the study centre approximately one time every 3 months. The study physician will increase or decrease the number of visits to the study centre as needed according to your disease condition. Additional information found here: Study Details | NCT06641414 | Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4). | ClinicalTrials.gov For questions, contact: [email protected]