Clinical Study of Venetoclax Combined With Azacitidine as Bridging Therapy Prior to Hematopoietic Stem Cell Transplantation in Patients With Higher-Risk Myelodysplastic Syndromes

About this trial

Last updated 10 months ago

Study ID

2025-HS-061

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Started a year ago

What is this trial about?

A Single-Arm, Prospective Clinical Study of Venetoclax Combined with Azacitidine Followed by Bridging Transplantation in Patients with High-Risk Myelodysplastic Neoplasms with Increased Blasts 2 (MDS-IB2)

What are the participation requirements?

Inclusion Criteria

1. Newly diagnosed MDS confirmed by morphological and immunophenotypic analysis of bone marrow；

2. Age ≥18 years, any gender；

3. Bone marrow blasts ≥10%；

4. IPSS-R score >4.5；

5. ECOG performance status 0-2；

6. Scheduled for allogeneic hematopoietic stem cell transplantation (allo-HSCT)；

7. Adequate major organ function：

* Cardiac: LVEF ≥50%

* Hepatic: Bilirubin ≤1.5×ULN

* AST/ALT ≤2.5×ULN

* Renal: Creatinine clearance ≥60 mL/min；

8. Written informed consent provided by the patient or legally authorized representative.

Exclusion Criteria

1. Extramedullary disease involvement；

2. Hypersensitivity to any study drugs；

3. Clinically significant hepatic/renal dysfunction exceeding inclusion thresholds；

4. Severe cardiac disease, including congestive heart failure, myocardial infarction, and cardiac insufficiency;

5. Concurrent malignant tumors of other organs, which can be enrolled if previously cured;

6. Active tuberculosis or HIV infection;

7. Concomitant hematologic disorders;

8. Pregnancy or lactation;

9. Inability to comply with protocol requirements;

10. Concurrently participating in other clinical studies.