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Clinical Trials in China / NCT07047183
Recruiting Phase 2

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

NCT07047183 · tracked via the Priya Life Science China tracker
Sponsor
Yehui Tan
Phase
Phase 2
Started
2025-07-01
Last updated
2025-08-08

Condition(s) studied

Myelodysplastic NeoplasmsTransplantation

Investigational drug(s) / intervention(s)

VEN (Venetoclax) →

VEN (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

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Hospital of Jilin University Changchun Jilin Recruiting

More Yehui Tan trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07047183 on ClinicalTrials.gov ↗ ← All trials in China