Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lisaftoclax (APG-2575), Azacitidine Injection, Placebo.
- Who it may be relevant to
- Registry conditions: Higher-risk Myelodysplastic Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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).
Overview
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.
Detailed description
This study intends to enroll patients with HR-MDS to receive the therapy of Lisaftoclax (APG-2575) combined with azacitidine (AZA) or placebo combined with azacitidine.
Interventions
- Drug Lisaftoclax (APG-2575)
QD, oral administration. - Drug Azacitidine Injection
QD, hypodermic or intravenous injection. - Other Placebo
QD, oral administration.
Primary outcome measures
- Overall Survival（OS） [Time frame: Up to 5 years]
Secondary outcome measures (1)
- Safety evaluation based on the adverse event concurrence [Time frame: Up to 5 years]
Eligibility criteria
Inclusion criteria
- Newly diagnosed higher-risk MDS.
- ECOG score of ≤2.
- Expected survival ≥ 3 months.
- Adequate organ function.
- 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.
- 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.
- Subjects are able to complete study procedures and follow-up examinations.
Exclusion criteria
- Concomitant other malignancies or prior malignancies with disease-free intervals of less than 1 year at the time of signing the informed consent.
- Have undergone hematopoietic stem cell transplantation.
- Uncontrolled active infection
- Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 days prior to the first dose of study drug.
- MDS or other conditions that cannot be administered enterally.
- Any condition that the subject is deemed to be inappropriate to participate in this study after evaluation by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT06641414 · APG2575MG301