Higher-risk Myelodysplastic Syndrome
Conditions
Keywords
Higher-risk Myelodysplastic Syndrome, Lisaftoclax
Brief summary
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
QD, oral administration.
QD, hypodermic or intravenous injection.
OTHERPlacebo
QD, oral administration.
Sponsors
Ascentage Pharma Group Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival（OS） | Up to 5 years | The primary endpoint was overall survival (OS), defined as the time from the date of randomization to the date of death of any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluation based on the adverse event concurrence | Up to 5 years | Number of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated. |
Countries
China, United States
Contacts
Primary ContactYifan Zhai, M.D., Ph.D.
Backup ContactQian Niu, M.D.
Outcome results
None listed