Actively Recruiting
Venetoclax-containing Therapy Combined With Microtransplant for Intermediate-risk and Higher MDS
Led by Beijing 302 Hospital · Updated on 2025-11-25
40
Participants Needed
1
Research Sites
310 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the safety and efficacy of a Venetoclax and hypomethylating agent-based regimen combined with infusion of HLA-mismatched donor G-CSF mobilized peripheral blood mononuclear cells (GPBMC) in patients with intermediate-risk and higher myelodysplastic syndromes who are ineligible for allogeneic hematopoietic stem cell transplantation.
CONDITIONS
Official Title
Venetoclax-containing Therapy Combined With Microtransplant for Intermediate-risk and Higher MDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender, any race or ethnicity
- Confirmed diagnosis of myelodysplastic syndromes (MDS) according to WHO 5th edition based on histopathology and cytogenetics
- Classified as intermediate, high, or very high risk by Revised International Prognostic Scoring System (IPSS-R)
- Not eligible for or have refused allogeneic hematopoietic stem cell transplantation
- Adequate liver function: ALT and AST less than or equal to 3 times upper limit of normal, total bilirubin less than or equal to 1.5 times upper limit of normal
- Adequate kidney function: serum creatinine less than or equal to 2 times upper limit of normal or creatinine clearance at least 40 mL/min
- Normal heart function with left ventricular ejection fraction (LVEF) greater than 50% by echocardiogram
- Have a donor aged 18 years or older who is HLA matched at 0 to 7 out of 10 loci with at least 3 mismatched loci, willing to donate hematopoietic stem cells and provide consent
- Participant or legal representative able to understand and willing to sign informed consent
- Donor meets institutional criteria for related peripheral blood hematopoietic stem cell donation and can tolerate cell collection with signed consent
You will not qualify if you...
- Uncontrolled infection or bleeding
- Significant cardiovascular disease including uncontrolled or symptomatic arrhythmias, congestive heart failure, myocardial infarction within 6 months before screening, or NYHA class 3 or 4 heart disease
- Uncontrolled autoimmune diseases or requiring immunosuppressive therapy
- History of severe blood infusion reaction
- Nursing women, women of childbearing potential who test positive for pregnancy or unwilling to use contraception
- Psychiatric or cognitive conditions that impair ability to follow study protocol
- Major surgery within 4 weeks before enrollment
- Life-threatening illness other than MDS or uncontrolled other illnesses
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Hematology, the Fifth Medical Center of Chinese PLA General Hospital
Beijing, China, 100071
Actively Recruiting
Research Team
B
Bo Cai, MD
CONTACT
F
Fei Peng, MD
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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