Actively Recruiting
Clinical Study of Venetoclax Combined With Azacitidine as Bridging Therapy Prior to Hematopoietic Stem Cell Transplantation in Patients With Higher-Risk Myelodysplastic Syndromes
Led by Yehui Tan · Updated on 2025-08-08
46
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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)
CONDITIONS
Official Title
Clinical Study of Venetoclax Combined With Azacitidine as Bridging Therapy Prior to Hematopoietic Stem Cell Transplantation in Patients With Higher-Risk Myelodysplastic Syndromes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed myelodysplastic syndrome confirmed by bone marrow analysis
- Age 18 years or older, any gender
- Bone marrow blasts 10% or higher
- IPSS-R score greater than 4.5
- ECOG performance status between 0 and 2
- Scheduled for allogeneic hematopoietic stem cell transplantation
- Adequate organ function with cardiac LVEF 50% or higher
- Hepatic bilirubin level 1.5 times the upper limit of normal or less
- AST and ALT levels 2.5 times the upper limit of normal or less
- Renal creatinine clearance 60 mL/min or higher
- Provided written informed consent
You will not qualify if you...
- Presence of extramedullary disease
- Allergy or hypersensitivity to study drugs
- Significant liver or kidney dysfunction beyond specified limits
- Severe heart disease including congestive heart failure or recent myocardial infarction
- Other active cancers except previously cured malignancies
- Active tuberculosis or HIV infection
- Other concurrent blood disorders
- Pregnancy or breastfeeding
- Unable to follow study protocol
- Participation in other clinical trials at the same time
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Hospital of Jilin University
Changchun, Jilin, China, 130000
Actively Recruiting
Research Team
Y
Yehui Tan
CONTACT
Y
Yuying Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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