A Real-World Study of Lisaftoclax (APG-2575) in Combination with Hypomethylating Agents in Patients with Intermediate- and High-Risk Myelodysplastic Syndromes (MDS)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600123533

Enrollment

Unknown

Registered

2026-04-27

Start date

2026-05-01

Completion date

Unknown

Last updated

2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndrome

Interventions

Observation group:Lisaftoclax in Combination with Hypomethylating Agents

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age >=18 and 3 or IPSS-M >0), with bone marrow blasts =3 months. 5. Able to receive oral medication. 6. Adequate hepatic function: AST/ALT =30 mL/min. 8. Willing to participate in the study voluntarily and provide written informed consent .

Exclusion criteria

Exclusion criteria: 1. Prior hematopoietic stem cell transplantation (HSCT). 2. History of or concurrent other malignancies (except those considered by the investigator not to affect the study, such as cured basal cell carcinoma of the skin or carcinoma in situ, which can be detailed per center regulations). 3. Known hypersensitivity to the study treatment drugs or their excipients. 4. Presence of significant malabsorption or other conditions that would make oral administration unfeasible. 5. Severe psychiatric or neurological diseases that affect compliance or the ability to provide informed consent. 6. Concurrent severe cardiovascular/cerebrovascular disease or other severe systemic diseases, which in the investigator's judgment would make the patient unable to tolerate the study treatment. 7. Known HIV infection. 8. Active Hepatitis B or Hepatitis C infection (laboratory criteria and management strategies for "active phase" can be defined according to your hospital/guidelines). 9. Pregnant or breastfeeding women, or those unwilling/unable to comply with the study's contraceptive requirements. 10. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.

Design outcomes

Primary

Measure	Time frame
Composite Complete Remission Rate (cCRR);	—

Secondary

Measure	Time frame
Overall Response Rate (ORR);Overall Survival (OS);Event-Free Survival (EFS);Transfusion Independence (TI);Time to Transformation to AML;Time to Response (TTR);Duration of Response (DOR);30-day Mortality Rate;	—

Countries

China

Contacts

Public ContactXiuli Sun

The First Affiliated Hospital of Dalian Medical University

sunxiuli@dmu.edu.cn+86 180 9887 5696

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026