The Efficacy of Allogeneic Hematopoietic Stem Cell Transplantation in Newly Diagnosed High-relapse-risk CEBPA Mutant Acute Myeloid Leukemia

Korábbi kezelés

• Concomitant other hematologic diseases (including coagulation abnormalities unrelated to leukemia);

Más betegség

• Allergies or contraindications to any of the drugs involved in the protocol;
• Lung diseases: pulmonary edema, pleural effusion (CTCAE score >2);
• Suffering from malignant tumors of other organs at the same time;
• Active patients with HAV, HBV, HCV and tuberculosis, HIV-positive patients;
• Those who participate in other clinical studies at the same time; Presence of any other condition that would preclude the conduct of the study

Laborértékek

• Cardiac disease: including echocardiogram EF <50%, cardiac insufficiency (New York cardiac function classification NYHA: III/IV), pericardial effusion (CTCAE score >2) within six months after acute myocardial infarction, ECG QTc >470ms;

Egyéb

• MDS-converted AML, treatment-related AML; mixed cell leukemia; AML patients with central nervous system infiltrates and extramedullary lesions at the time of onset;
• Relapse patients;
• Liver and kidney function are obviously abnormal, exceeding the enrollment criteria;
• Inability to understand or follow the study protocol;

• Patients with confirmed CEBPA mutant AML. Diagnostic criteria include the presence of CEBPA mutant gene detected at the molecular level;
• Patients with high-risk molecular markers or gene mutations, or complex karyotypes for disease recurrence, or flow cytometry/gene MRD positivity after two chemotherapy treatments; high-risk molecular markers or gene mutations include: CD7 positive, WT1 mutation, non-bzip-inframe CEBPA mutation; The positive threshold for flow cytometry MRD was 0.0001%; The MRD threshold of molecular biology is the lowest value of the detection protocol of the center.
• Medical history and diagnosis of MICM, exclusion of MDS, transformation and treatment-related AML;
• Age 18-65 years old (18 years old ≤Age< 65 years old);
• Liver and kidney function: blood bilirubin ≤ 35 μmol/L, AST/ALT below 2 times the upper limit of normal, serum creatinine ≤ 150 μmol/L;
• Normal cardiac function (EF≥50%, New York Cardiac Function Classification NYHA I/II);
• Physical condition score 0-2 (ECOG score);
• For patients with peripheral blood leukocytes < 50*109/L at the initial onset, no chemotherapy has been given except for hydroxyurea before the start of induction therapy;
• For patients with peripheral blood leukocytes ≥ 50*109/L at the initial onset, cytarabine and hydroxyurea are allowed to be treated before the start of induction therapy;
• Non-pregnant and lactating women;
• For all women of childbearing age, a pregnancy test must be performed to measure hCG to rule out pregnancy;
• Obtain informed consent signed by the patient or family member.