Multi-target Drugs Sequential Combination Therapy in Adults Patients With Newly Diagnosed Primary Immune Thrombocytopenia

The study will be conducted in three phases.Phase 1. Core treatment phase includes initial treatment and sequential combinationtherapy (12 weeks, weeks 1‐12):Patients will receive standard‐dose methylprednisolone or prednisone in combination witha thrombopoietin receptor agonist (TPO‐RA) as initial therapy.Corticosteroids will betapered and discontinued within 8 weeks; tapering will begin immediately in patients whoachieve complete response (CR) and will also be initiated after 4 weeks in patients whodo not achieve response (R). TPO‐RA therapy will continue for 12 weeks, with doseadjustments made according to the approved prescribing information. Patients withtreatment failure( defined as platelet count < 30 × 10^9/L or less than 2‐fold increaseof baseline platelet count or bleeding) after 2 weeks of initial therapy (Weeks 3‐12)will receive the ongoing TPO‐RA in combination with either rituximab or an anti‐CD38monoclonal antibody as sequential combination therapy.Phase 2. Core‐treatment follow‐up and exploratory treatment phase (24weeks, weeks 13‐36):During the core treatment follow‐up phase, patients with treatment failure will enter theexploratory treatment phase. Patients who did not receive rituximab or anti‐CD38monoclonal antibody during the core treatment phase will receive a switched TPO‐RAcombined with either rituximab or anti‐CD38 monoclonal antibody, whereas patients whoreceived either rituximab or anti‐CD38 monoclonal antibody during the core phase willreceive a switched TPO‐RA combined with cross‐administered rituximab and anti‐CD38monoclonal antibody.TPO‐RA therapy will also continue for 12 weeks.Phase3. Safety follow‐up phase (4weeks,weeks 37‐40).Rescue therapy includes, but is not limited to, intravenous immunoglobulin (IVIG),platelet transfusion, and vindesine. A switch to another thrombopoietin receptor agonist(TPO‐RA) will be considered rescue therapy during the core treatment period.Administration of recombinant human thrombopoietin (rhTPO) will also be considered rescuetherapy.