eligibility_summary
Eligibility: 12–18 yrs with persistent/chronic ITP, platelets <30×10^9/L (twice), failed/relapsed or steroid‑dependent, emergency ITP therapy ≥2 wks prior, consent, LFT/renal <1.5×ULN, ECOG ≤2, NYHA ≤2, stable maintenance meds ≥4 wks, rituximab >3 mo, splenectomy >6 mo. Exclude: secondary ITP causes, major organ/immune disease, HIV/active hepatitis/CMV/EBV/syphilis, severe bleeding, uncontrolled cardiac/HTN, thrombosis/atherosclerosis, malignancy/transplant, serious comorbidity, antiplatelets.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm pediatric ITP trial of obinutuzumab (Gazyva), a glycoengineered, type II anti-CD20 monoclonal antibody immunotherapy, given once IV (1000 mg). Mechanism: binds CD20 on B lymphocytes and depletes them via enhanced type II direct cell death (DCD) and increased Fc-mediated antibody-dependent cellular cytotoxicity (ADCC), with relatively reduced complement-dependent cytotoxicity compared with rituximab. Targets: CD20+ B cells that produce antiplatelet autoantibodies, modulation of humoral autoimmunity and Fc-effector pathways (e.g., NK-cell ADCC), aiming to reduce immune-mediated platelet destruction and restore platelet counts in steroid-refractory/relapsed pediatric ITP.