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
Trial Parameters
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: 1. Age 14-65 years (inclusive), regardless of gender. 2. Newly diagnosed B-ALL with CD19 expression on leukemic cells (regardless of CD19 positivity rate). 3. Ph-negative B-ALL with high-risk features post-allo-HSCT . 4. ≥2 months post-transplant with hematopoietic reconstitution. 5. Bone marrow morphology in remission and MRD-negative before enrollment. 6. ECOG performance status \<3 and Karnofsky score ≥70. 7. No history of grade III/IV graft-versus-host disease (GVHD) and no active GVHD at enrollment. 8. Adequate organ function:AST and ALT ≤3× upper limit of normal (ULN), total bilirubin ≤2×ULN.Serum creatinine ≤2×ULN or creatinine clearance ≥50 mL/min (calculated by Cockcroft-Gault formula).Left ventricular ejection fraction (LVEF) ≥50% by echocardiography (ECHO). 9. Expected survival \>3 months. 10. Voluntary provision of written informed consent, with ability to understand and comply with study requirements. Exclusion Criteria: 1. History of hypersensitivity o