Actively Recruiting
The Efficacy of Allo-HSCT in ND HR-CBF-AML
Led by Ruijin Hospital · Updated on 2026-04-16
90
Participants Needed
1
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
For newly diagnosed high-relapse-risk core-binding-factor acute myeloid leukemia participants, the investigators aim to perform allogeneic hematopoietic stem cell transplantation after participants finished one cycle of induction and two cycles of consolidation. To access whether the therapeutic regimen is effective for high-relapse-risk core-binding-factor acute myeloid leukemia, the disease-free-survival (DFS), overall survival (OS), non-relapse-mortality of participants is evaluated.
CONDITIONS
Official Title
The Efficacy of Allo-HSCT in ND HR-CBF-AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with confirmed core-binding-factor acute myeloid leukemia diagnosed by specific genetic markers such as t(8;21)(q22;q22)/RUNX1-RUNX1T1 or inv(16)(p13.1q22)/t(16;16)(p13.1;q22) with CBFβ-MYH11 fusion gene
- Presence of high-risk gene mutations, complex karyotypes for disease recurrence, or positive measurable residual disease after two chemotherapy treatments
- Medical history and diagnosis of MICM; exclusion of MDS, transformation, and treatment-related AML
- Age between 18 and 65 years
- Liver and kidney function within specified limits: blood bilirubin ≤ 35 µmol/L, AST/ALT below 2 times upper limit of normal, serum creatinine ≤ 150 µmol/L
- Normal cardiac function with ejection fraction ≥ 50% and New York Heart Association Class I or II
- Physical condition score (ECOG) between 0 and 2
- For participants with peripheral blood leukocytes < 50×10⁹/L at onset, no chemotherapy except hydroxyurea before induction therapy
- For participants with peripheral blood leukocytes ≥ 50×10⁹/L at onset, cytarabine and hydroxyurea allowed before induction therapy
- Non-pregnant and not breastfeeding women
- Negative pregnancy test for all women of childbearing age
- Signed informed consent by participant or family member
You will not qualify if you...
- MDS-converted AML, treatment-related AML, mixed cell leukemia, or AML with central nervous system infiltration or extramedullary lesions at onset
- Relapsed AML
- Allergies or contraindications to drugs in the study protocol
- Abnormal liver or kidney function exceeding enrollment criteria
- Cardiac disease including ejection fraction < 50%, heart failure NYHA Class III/IV, recent pericardial effusion, or prolonged QTc interval
- Lung diseases such as pulmonary edema or pleural effusion with significant severity
- Presence of malignant tumors in other organs
- Active infections with hepatitis A, B, C, tuberculosis, or HIV positive
- Other hematologic diseases including coagulation abnormalities unrelated to leukemia
- Inability to understand or follow the study protocol
- Participation in other clinical studies simultaneously
- Any other condition that would prevent study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital Affiliated to Shanghai Jiaotong University School Of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
Y
Yang Shen, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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