Actively Recruiting
The Efficacy of Allogeneic Hematopoietic Stem Cell Transplantation in Newly Diagnosed High-relapse-risk CEBPA Mutant Acute Myeloid Leukemia
Led by Ruijin Hospital · Updated on 2025-07-29
50
Participants Needed
1
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
For newly diagnosed high-relapse-risk CEBPA mutant acute myeloid leukemia patients, we aim to perform allogeneic hematopoietic stem cell transplantation after patients finished one cycle of induction and two cycles of consolidation. To access whether the therapeutic regimen is effective for high-relapse-risk CEBPA mutant acute myeloid leukemia, the disease-free-survival (DFS), overall survival (OS), non-relapse-mortality of patients is evaluated.
CONDITIONS
Official Title
The Efficacy of Allogeneic Hematopoietic Stem Cell Transplantation in Newly Diagnosed High-relapse-risk CEBPA Mutant Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed CEBPA mutant acute myeloid leukemia detected at the molecular level
- Presence of high-risk molecular markers or gene mutations, complex karyotypes, or MRD positivity after two chemotherapy treatments
- Medical history and diagnosis of MICM, excluding MDS, transformation, and treatment-related AML
- Age between 18 and 65 years old
- Liver and kidney function within specific limits: bilirubin ≤ 35 μmol/L, AST/ALT below twice the upper normal limit, serum creatinine ≤ 150 μmol/L
- Normal cardiac function with ejection fraction ≥ 50% and NYHA class I or II
- Physical condition score between 0 and 2 (ECOG score)
- For patients with peripheral blood leukocytes < 50×10^9/L at onset, no chemotherapy except hydroxyurea before induction therapy
- For patients with peripheral blood leukocytes ≥ 50×10^9/L at onset, cytarabine and hydroxyurea allowed before induction therapy
- Non-pregnant and non-lactating women
- Negative pregnancy test for women of childbearing age
- Signed informed consent obtained from patient or family member
You will not qualify if you...
- MDS-converted AML, treatment-related AML, mixed cell leukemia, CNS infiltrates, or extramedullary lesions at onset
- Relapsed patients
- Allergies or contraindications to drugs in the study protocol
- Abnormal liver or kidney function exceeding inclusion criteria
- Cardiac disease including ejection fraction <50%, NYHA class III/IV, recent pericardial effusion or abnormal ECG QTc >470 ms
- Lung diseases such as pulmonary edema or pleural effusion with CTCAE score >2
- Presence of other malignant tumors
- Active infections with HAV, HBV, HCV, 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
- Any other condition preventing study participation
AI-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
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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