Sonrotoclax in Combination With Azacitidine for Previously Untreated Higher-risk Myelodysplastic Syndromes

Inclusion Criteria:

1. Aged ≥ 18 years.

2. Diagnosed with myelodysplastic syndromes (MDS) based on bone marrow morphology, immunophenotyping, cytogenetics, and molecular testing, consistent with the WHO 2016 or 2022 classification criteria.

3. High-risk MDS defined by any of the following risk stratification systems:

   • nbsp; a) IPSS-R score > 3.5; or
   • nbsp; b) IPSS score > 1; or
   • nbsp; c) IPSS-M score > 0.

4. No prior anti-tumor treatment for MDS, including hypomethylating agents or chemotherapy.

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

6. Expected survival time ≥ 12 weeks.

7. Adequate major organ function as defined below:

   • nbsp; a) Creatinine clearance ≥ 50 mL/min;
   • nbsp; b) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN;Left ventricular ejection fraction (LVEF) ≥ 45%.

8. Written informed consent must be obtained from the patient, legal representative, or guardian prior to any study-related procedures. The study protocol has been approved by the institutional ethics committee.

Exclusion Criteria:

1. Diagnosis of acute promyelocytic leukemia (APL).
2. Prior treatment with any BCL-2 inhibitor.
3. History of other malignant tumors within the past 3 years (excluding cured malignancies).
4. Presence of active and uncontrolled infectious diseases.
5. Central nervous system (CNS) involvement.
6. Severe and uncontrolled cardiac disease.
7. Dry tap on bone marrow aspiration or grade 2-3 myelofibrosis.
8. Pregnancy or breastfeeding status.
9. Any other condition deemed inappropriate for study enrollment by the investigator.