Phase 2 Trial of BN104 as Post-HSCT Maintenance in Acute Leukemia

Inclusion Criteria

• •Male or female patients.
• •Adult and adolescent patients aged ≥12 years who must weight ≥35 kg.
• •Diagnosed with acute myeloid leuekmia, acute lymphoblastic leukemia or ambiguous acute leukemia according to the World Health Organization classification of hematologic neoplams (WHO 2022).
• •Intermediate or high risk accroding to the ELN risk stratification.
• •Harboring one of the following genetic aberrations: a. somatic NPM1 mutation (without FLT3-ITD/TKD co-mutations); b. KMT2A rearrangement/KMT2A-PTD; c. NUP98 rearrangement; d. other genetic alterations dependent on menin-KMT2A.
• •Received allogenic hematopoietic stem cell transplantation within 30-180 days at the initiation of BN104 maintenance therapy.
• •Achieved full donor chimerism and hematologic recovery, with acute neuthrophil count (ANC) ≥1.0×10⁹/L, platelets ≥75×10⁹/L (no red blood cells /platelets transfusion within 7 days, no G-CSF or GM-CSF within 72 hours).
• •Complete hematological remission (CHR) after first allo-SCT. CHR must be confirmed by bone marrow analysis within 14 days before entering the study (CHR criteria are: "\< 5% marrow blasts, no peripheral blasts, blood platelet count \> 75×10⁹/L, WBC count \> 3.5 G/L, ANC ≥ 1.0×10⁹/L).
• •No extramedullary leukemia.
• •Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.
• •Adequate organ function
• •Provided informed consent by all patients and the guardians ( aged 12-17 years).
• •Written informed consent.
• •ECOG ≥ 2.