RecruitingPhase 2NCT07047183

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

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)

Sponsor

Yehui Tan

Enrollment

46 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Myelodysplastic Neoplasms Transplantation

Summary

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)

Eligibility

Min Age: 18 Years

Inclusion Criteria12

Newly diagnosed MDS confirmed by morphological and immunophenotypic analysis of bone marrow；
Age ≥18 years, any gender；
Bone marrow blasts ≥10%；
IPSS-R score >4.5；
ECOG performance status 0-2；
Scheduled for allogeneic hematopoietic stem cell transplantation (allo-HSCT)；
Adequate major organ function：
Cardiac: LVEF ≥50%
Hepatic: Bilirubin ≤1.5×ULN
AST/ALT ≤2.5×ULN
Renal: Creatinine clearance ≥60 mL/min；
Written informed consent provided by the patient or legally authorized representative.

Exclusion Criteria10

Extramedullary disease involvement；
Hypersensitivity to any study drugs；
Clinically significant hepatic/renal dysfunction exceeding inclusion thresholds；
Severe cardiac disease, including congestive heart failure, myocardial infarction, and cardiac insufficiency;
Concurrent malignant tumors of other organs, which can be enrolled if previously cured;
Active tuberculosis or HIV infection;
Concomitant hematologic disorders;
Pregnancy or lactation;
Inability to comply with protocol requirements;
Concurrently participating in other clinical studies.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGVEN (Venetoclax)

Enrolled patients will receive: Venetoclax: 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3-14. Azacitidine: 75 mg/m² on Days 1-7. Cycle duration: 28 days Total cycles: 1 to 2 cycles