Umbilical Cord Blood Consolidation for Older Adults With Intermediate- and High-Risk AML

Inclusion Criteria:

1. Age between 60 and 80 years old, inclusive.

2. Diagnosis of acute myeloid leukemia (AML) confirmed by bone marrow morphology and immunophenotyping, meeting all sub-criteria below:

   ① Bone marrow morphology: Bone marrow blasts <5%, without features of leukemic infiltration;

   ② Cytogenetics: Carrying common chromosomal abnormalities including t(8;21), t(16;16), t(9;11), t(6;9), t(9;22), etc. Patients with t(15;17)(q22;q21) are excluded;

   ③ Molecular genetics: Harboring common fusion genes including AML1-ETO, CBFβ-MYH1, MLL-related fusions; patients with positive PML-RARα are excluded. Common gene mutations include NPM1, FLT3-ITD, CEBPA and c-kit;

   ④ Immunophenotyping: Single-lineage AML with a lymphoid antigen score of 0.

3. Achieved complete remission (CR), complete remission with partial hematologic recovery (CRh), or complete remission with incomplete hematologic recovery (CRi) after frontline induction chemotherapy; OR achieved CR/CRh/CRi followed by one cycle of consolidation with the original induction regimen.
4. Stratified as intermediate-risk or high-risk AML per the 2022 European LeukemiaNet (ELN) risk classification; patients with TP53 mutation or complex karyotype are excluded.
5. Adequate hepatic and renal function: total bilirubin ≤35 μmol/L; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2× upper limit of normal (ULN); serum creatinine ≤150 μmol/L.
6. Adequate cardiac function: resting left ventricular ejection fraction (LVEF) ≥50% on echocardiogram.
7. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2. Written informed consent signed by the patient and/or legal guardian.

Exclusion Criteria:

• 1.Confirmed diagnosis of acute promyelocytic leukemia (APL). 2.Relapsed or refractory AML, mixed-phenotype acute leukemia, or concomitant other hematological malignancies (including but not limited to lymphoma, multiple myeloma, immune thrombocytopenia (ITP), and other diseases whose treatment with immunosuppressants may interfere with immune reconstitution after cord blood infusion).

  3.Known hypersensitivity to any study drug specified in the protocol. 4.Clear contraindication to chemotherapy as judged by the investigator. 5.History of other malignant tumors within the past 5 years, excluding cured basal cell carcinoma of the skin, localized cutaneous squamous cell carcinoma, cervical carcinoma in situ or breast carcinoma in situ.

  6.Clinically significant active infection requiring systemic antibiotic therapy (including bacterial, viral and fungal infections) as assessed by the investigator, or seropositive for human immunodeficiency virus (HIV).

  7.Active autoimmune diseases requiring systematic treatment within the past 2 years (e.g., diseases requiring corticosteroids or immunosuppressive agents).

  8.Pregnant or breastfeeding female patients. 9.Unable to understand or comply with the study protocol. 10.Concurrent participation in another interventional clinical trial. 11.Any other condition that may hinder the implementation of the study, as determined by the investigator.