The Investigate Efficacy and Safety Evaluation of Bortezomib in Patients With Relapsed/Refractory Immune Thrombocytopenia

Inclusion Criteria

• •1. Men and women 19 years of age and older
• •2. Patients diagnosed with immune thrombocytopenia (primary or secondary)
• •3. (Patients with at least one of B, C, or D meeting A below.) A.A person who has been confirmed not to be due to a cause of decreased platelet production in the bone marrow in the results of bone marrow examination within the past 5 years. (Bone marrow examination is required if there is no bone marrow examination result within the last 5 years.) B.After being diagnosed with ITP, there has been a case of complete platelet response with plt \>100k in immunoglobulin therapy.
• •C.Patients suspected of having primary immune thrombocytopenia with proven anti-platelet antibody., D.Helicobacter IgG, antinuclear antibody (ANA), anticardiolipin antibody (ACA), nonspecific inhibitor (NSI), etc. have been proven, and secondary immune thrombocytopenia caused by autoimmune disease is suspected.
• •4. platelets \<30 x 109/L
• •5. Patients in need of clinical treatment.
• •6. Patients who have relapsed or refractory after receiving treatment with corticosteroids (prednisolone cumulative dose 5.6mg/kg (0.8mg/kg 1 week) or more or dexamethasone cumulative dose 80mg (20mg 4 days) or more)., However, there are exceptions when corticosteroids are contraindicated.
• •7. Patients who have been relapsed or refractory after receiving at least 2 treatments with a mechanism other than corticosteroids.
• •8. Patients who underwent two different treatments from among the treatment methods below.
• •* Splenectomy
• •* eltrombopag or romiplostim
• •* Rituximab treatment
• •* Azathioprine
• •* cyclosporine or mycophenolate mofetil(MMF)
• •* vincristine or cyclophosphamide
• •* danazol
• •* dapsone
• •* Alemtuzumab
• •9. Female patients of childbearing potential should have a negative urine or serum pregnancy test within 28 days before starting administration of the test drug.
• •10. Patients who voluntarily or legal guardians have given written consent to participate in this clinical trial.