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).
First Affiliated Hospital of Zhejiang University
Lead sponsor