A single-arm trial to evaluate the effectiveness and safety of Blinatumomab and Donor Lymphocyte Infusion in maintenance therapy after allogeneic hematopoietic stem cell transplantation for high-risk Ph negative B cell acute lymphoblastic leukemia
Age 14-65 years (inclusive), regardless of gender.
Newly diagnosed B-ALL with CD19 expression on leukemic cells (regardless of CD19 positivity rate).
Ph-negative B-ALL with high-risk features post-allo-HSCT .
≥2 months post-transplant with hematopoietic reconstitution.
History of hypersensitivity or severe adverse reactions to the study drug or structurally similar compounds, as assessed by the investigator to preclude participation.
Pregnant or lactating women, or women of childbearing potential unwilling to use effective contraception.
Severe cardiac dysfunction, including:Left ventricular ejection fraction (EF) <60%.Clinically significant arrhythmias (e.g., ventricular tachycardia, atrial fibrillation, second-degree heart block).Prolonged QTc interval (men >450 ms; women >470 ms).Myocardial infarction within the past year.Symptomatic coronary artery disease requiring medication.
Severe pulmonary dysfunction (obstructive and/or restrictive ventilatory impairment).
Single group
BITE and DLI
DrugBlinatumomab dosage: Cycle 1 (starting at day 60 post-transplant):Days 1-3: 9 μg/day，Days 4-14: 28 μg/day Cycles 2-4:Days 1-14: 28 μg/day Administration method: Continuous 24-hour intravenous infusion, one cycle every 3 months. DLI eligibility criteria:No history of grade III-IV acute GVHD (aGVHD).No active aGVHD or chronic GVHD (cGVHD) at the time of infusion DLI dosage:Administered at day 120 post-HSCT, CD3+ cell dose: 1 × 10⁷/kg
The 2-year leukemia-free survival (LFS) after allo-HSCT.
The 2-year overall survival（OS）
2-year overall survival from transplant
The 2-year cumulative incidence of relapse
The 2-year cumulative incidence of non-relapse mortality(NRM)
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