eligibility_summary
Adults (≥18) with CD22+ B-ALL ≥60 days post allo- or auto-HSCT, high-risk/relapsed/refractory or MRD+ pre-HSCT, ECOG ≤2, ANC >1,000 (3 d) and platelets >50k (7 d), consent. For allo-HSCT: donor chimerism >99%. Exclude: active progression, unresolved ≥G2 toxicity, major renal (<50 mL/min), hepatic (>2×ULN), cardiac/pulmonary dysfunction, grade III–IV or hepatic GVHD, VOD, other active malignancy, uncontrolled illness/infection, active HBV/HCV (PCR+), other risks, drug allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II single-arm prevention trial testing post‑HSCT low‑dose inotuzumab ozogamicin in adults with high‑risk CD22+ B‑ALL. Drug/intervention: Inotuzumab ozogamicin, an antibody‑drug conjugate (humanized anti‑CD22 IgG4 mAb linked to calicheamicin). Mechanism: binds CD22 on B‑cell blasts, is internalized, then releases calicheamicin which induces DNA double‑strand breaks and apoptosis. Dosing: 0.3 mg/m2 around day +60 post‑transplant, then 0.6 mg/m2 one month later. Targets: CD22 (Siglec‑2) on malignant B‑lineage cells, downstream DNA damage/apoptosis pathways. Goals: reduce relapse, improve 1‑yr DFS (primary), assess relapse, non‑relapse mortality, OS, and safety (hematologic toxicity, secondary graft failure, AEs).