eligibility_summary
Eligible: Ages 16–65 with high-risk, CD19+ B-ALL, a suitable hematopoietic stem cell donor, and no vital organ dysfunction. Exclude: CR/MRD-negative before blinatumomab maintenance, active hepatitis B, HIV, or other active infections, acute/chronic GVHD requiring systemic immunosuppression, severe organ impairment, or any condition deemed unsuitable by investigators.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06438796 tests blinatumomab as post–allo-HSCT maintenance for high-risk B-ALL. Intervention: blinatumomab 9 μg/day by continuous IV infusion for 14 days, every 3 months for up to 4 cycles starting ~day 90–120 post-transplant. Control: center-standard maintenance (e.g., decitabine, sorafenib, prophylactic DLI), excluding CD19 antibodies and CD22-ADCs. Drug/type/mechanism: Blinatumomab is a bispecific T‑cell engager (BiTE) antibody construct (immunotherapy biologic) that binds CD19 on B cells and CD3 on T cells, redirecting cytotoxic T cells to kill CD19+ leukemia via TCR/CD3 activation and immune synapse–mediated perforin/granzyme lysis. Target cells/pathways: CD19-expressing B‑lymphoblasts, effector T cells via CD3/TCR signaling, aims to reduce MRD and prevent relapse by enhancing graft‑versus‑leukemia without added GVHD.