GLORA-4
Research type
Research Study
Full title
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)
IRAS ID
1011274
Contact name
Yifan Zhai
Contact email
Sponsor organisation
Ascentage Pharma Group Inc.
Eudract number
2024-517247-31
Clinicaltrials.gov Identifier
Research summary
The main purpose of this study is to evaluate the efficacy and safety difference of lisaftoclax also known as APG-2575 in combination with azacitidine (AZA) compared to a matching placebo of APG-2575 in combination with AZA in patients with newly diagnosed higher risk Myelodysplastic Syndrome (HR-MDS).
Participation in this study will include an approximately 1 month screening period. The total number of cycles of treatment received in this study and how long participants will be in the study will depend on factors such as their tolerance to the study drug, whether their disease is stable or improving. Participants will continue to receive treatment until documented disease progression as determined by the study doctor, intolerable side effects, withdrawal of consent, the study doctor feels that they need to receive other anti-tumour therapy.
After starting study drug therapy, participants will be followed on a cycle of 28 days (4 weeks) and will need to visit the site approximately 5-6 times during Cycle 1. Cycle 2, they will need to visit the site approximately 3-4 times per cycle for safety follow-up and an assessment of disease. The study doctor will increase or decrease the number of visits as needed according to their disease condition.
Once the participant is no longer on treatment, they will attend an end-of-treatment visit followed by a safety visit approximately 30 days from the last dose of study drug or start other anti-tumour therapy.
REC name
Wales REC 5
REC reference
25/WA/0024
Date of REC Opinion
17 Feb 2025
REC opinion
Further Information Favourable Opinion