New hope for High-Risk leukemia: stem cell transplant trial launches

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participants with confirmed CBF-AML. Diagnostic criteria include the presence of t(8; 21)(q22; q22)/RUNX1-RUNX1T1 fusion gene detected at the molecular level; or chromosome presence of inv(16)(p13.1q22)/t(16; 16)(p13.1; q22) /Detection of CBFβ-MYH11 fusion gene at the molecular level; 2. Participants with high-risk gene mutations or complex karyotypes for disease recurrence, or flow cytometry/gene MRD positivity after two chemotherapy treatments; High-risk gene mutations include: TP53, RTK/RAS signaling (FLT3, NRAS, KRAS, KIT, JAK2, CSF3R), chromatin modification (ASXL1, ASXL2, KMD6A, EZH2, SETD2) or mutations listed as intermediate-risk or high-risk in the 2022NCCN guidelines; 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. 3. Medical history and diagnosis of MICM, exclusion of MDS, transformation and treatment-related AML; 4. Age 18-65 years old (18 years old ≤Age\< 65 years old); 5. Liver and kidney function: blood bilirubin ≤ 35 μmol/L, AST/ALT below 2 times the upper limit of normal, serum creatinine ≤ 150 μmol/L; 6. Normal cardiac function (EF≥50%, New York Cardiac Function Classification NYHA I/II); 7. Physical condition score 0-2 (ECOG score); 8. For participants 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; 9. For participants 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; 10. Non-pregnant and lactating women; 11. For all women of childbearing age, a pregnancy test must be performed to measure hCG to rule out pregnancy; 12. Obtain informed consent signed by the patient or family member. Exclusion Criteria: 1. MDS-converted AML, treatment-related AML; mixed cell leukemia; AML with central nervous system infiltrates and extramedullary lesions at the time of onset; 2. Relapse AML; 3. Allergies or contraindications to any of the drugs involved in the protocol; 4. Liver and kidney function are obviously abnormal, exceeding the enrollment criteria; 5. 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; 6. Lung diseases: pulmonary edema, pleural effusion (CTCAE score \>2); 7. Suffering from malignant tumors of other organs at the same time; 8. Active patients with HAV, HBV, HCV and tuberculosis, HIV-positive patients; 9. Concomitant other hematologic diseases (including coagulation abnormalities unrelated to leukemia); 10. Inability to understand or follow the study protocol; 11. Those who participate in other clinical studies at the same time; Presence of any other condition that would preclude the conduct of the study.