Actively Recruiting
Venetoclax-containing Therapy Combined With Microtransplant for Newly Diagnosed AML
Led by Beijing 302 Hospital · Updated on 2025-07-28
50
Participants Needed
1
Research Sites
310 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate whether HLA-mismatched donor G-CSF mobilized peripheral blood mononuclear cell (GPBMC) infusion with venetoclax-containing regimens (microtransplant, MST) could improve survival in adult patients with newly diagnosed acute myeloid leukemia (AML).
CONDITIONS
Official Title
Venetoclax-containing Therapy Combined With Microtransplant for Newly Diagnosed AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender, any race or ethnicity
- No prior anti-acute leukemia treatment except hydroxyurea and/or leukapheresis
- Confirmed acute myeloid leukemia per WHO criteria with white blood cell count under 25 x 10^9/L
- Liver function tests (ALT, AST) no more than 3 times upper limit of normal and total bilirubin no more than 1.5 times upper limit
- Kidney function with serum creatinine no more than 2 times upper limit or creatinine clearance at least 40 mL/min
- Normal heart function with left ventricular ejection fraction over 50% measured by echocardiogram
- Has a donor at least 18 years old with HLA match 0-7/10 loci including at least 3 mismatched loci, who consents to donate hematopoietic stem cells
- Signed informed consent form by participant or legal representative
- Donor meets institution criteria for related peripheral blood stem cell donation and signs informed consent
You will not qualify if you...
- Acute promyelocytic leukemia, myeloid sarcoma, chronic myeloid leukemia in accelerated or blast phase
- Uncontrolled infection or bleeding
- Significant cardiovascular disease such as uncontrolled arrhythmias, congestive heart failure, recent myocardial infarction within 6 months, or NYHA class 3 or 4 heart disease
- Uncontrolled autoimmune disease or requiring immunosuppressive treatment
- History of severe blood transfusion reaction
- Nursing women, women of childbearing potential with positive pregnancy test or unwilling to use contraception
- Psychiatric or cognitive conditions likely to impair protocol adherence
- Major surgery within 4 weeks prior to enrollment
- Life-threatening illness other than AML or uncontrolled intercurrent illness
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
Y
Yangyang Lei, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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