Intensive Conditioning withTHI/Bu/Flu/Ara-C in Allo-HSCT for Myeloid Malignancies With Extramedullary Involvement

Prior treatment

• Any unstable systemic diseases, including but not limited to unstable angina, recent cerebrovascular accidents or transient ischemic attacks within the 3 months prior to screening, myocardial infarction within the 3 months prior to screening, congestive heart failure (New York Heart Association \[NYHA\] class ≥ III), severe arrhythmias requiring drug treatment after pacemaker implantation, significant liver, kidney, or metabolic diseases, and pulmonary arterial hypertension.
• Active hepatitis B (HBV) or active hepatitis C (HCV) requiring antiviral therapy.
  • Patients at risk of HBV reactivation, are defined as those who are positive for hepatitis B surface antigen or core antibody without receiving antiviral therapy.

Other illness

• History of malignancies other than myeloid tumors within the 5 years prior to screening, except for adequately treated in situ cervical cancer, basal cell carcinoma, squamous cell carcinoma of the skin, and curatively treated localized prostate cancer or ductal carcinoma in situ.
• Active, uncontrolled infections, including those associated with hemodynamic instability, new or worsening infection symptoms or signs, new infectious lesions on imaging, or persistent unexplained fever without signs or symptoms of infection.
• Conditions requiring treatment such as grade 2 or higher seizures, paralysis, aphasia, recent severe cerebral infarction, severe traumatic brain injury, dementia, Parkinson's disease, or schizophrenia.
• HIV-infected individuals.

Other

• ECOG \> 2.
• HCT-CI score ≥ 3.
• Pregnant or breastfeeding women.
• Fertile males and females unwilling to use contraception during the treatment period and for 12 months after treatment.

• Age between 18 and less than 55 years, regardless of gender.
• Criteria for myeloid tumors with extramedullary involvement:
  • AML (Acute Myeloid Leukemia) with at least one extramedullary lesion achieving hematological remission (CR1 or CR2) after induction therapy.
  • MDS (Myelodysplastic Syndrome) with at least one extramedullary lesion and bone marrow blast percentage ≥ 5% achieving hematological CR after treatment; CMML (Chronic Myelomonocytic Leukemia) with at least one extramedullary lesion (diagnosed according to WHO standards) achieving hematological CR after treatment.
  • Control and remission of extramedullary lesions, including those in the central nervous system, testes, skin, and other extramedullary tissues.
  • Granulocytic sarcoma with or without bone marrow involvement, and achieving remission after treatment.
• Patients must have a suitable hematopoietic stem cell donor:
  • Related donors must have at least 5/10 matches for HLA-A, -B, -C, -DQB1, and - DRB1.
  • Unrelated donors must have at least 8/10 matches for HLA-A, -B, -C, -DQB1, and
  • DRB1.
• Hematopoietic cell transplantation comorbidity index (HCT-CI) score ≤ 2.
• ECOG (Eastern Cooperative Oncology Group) performance status: 0-2.
• Adequate liver, kidney, and cardiopulmonary function, meeting the following requirements:
  • Serum creatinine ≤ 1.5x ULN (the upper limit of normal).
  • Cardiac function: Ejection fraction ≥ 50%.
  • Baseline oxygen saturation \> 92%.
  • Total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 2.0 x ULN.
  • Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40% and FEV1 (Forced Expiratory Volume in 1 second) ≥ 50%.
• Patients must have the ability to understand and be willing to participate in this study and sign an informed consent form.