None listed
Conditions
Interventions
Drug : Bortezomib is administered at D1, 4, and 8 at 1.3 mg/m2 iv or sc, and is administered every 3 weeks for up to 3 cycles.
Thereafter, follow-up is scheduled for 12 months.
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? 19 years of age or older. ? Those diagnosed with immune thrombocytopenia (primary or secondary). ? (If at least one of B, C, and D is satisfied while satisfying A below). A. A bone marrow examination within the past 5 years has proven that it is not due to a cause of decreased platelet production in the bone marrow, or (if there is no bone marrow examination within the past 5 years, bone marrow examination is required) B. Have had a complete platelet response of plt >100k through immunoglobulin therapy after being diagnosed with ITP, or C. Primary immune thrombocytopenia is suspected due to evidence of the presence of anti-platelet antibody; D. When secondary immune thrombocytopenia caused by autoimmune disease is suspected because Helicobacter IgG, antinuclear antibody (ANA), anticardiolipin antibody (ACA), nonspecific inhibitor (NSI), etc. have been proven. ? Platelets <30 x 109/L ? Those in need of clinical treatment. ? In case of relapse or refractory after 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) treatment. The exception is when corticosteroids are contraindicated. ? In case of relapse or refractory after at least 2 treatments other than corticosteroids. ? When two different treatments were performed among the following treatment methods - Splenectomy - Revolade (eltrombopag) or Enplate (romiplastim) - Treatment with Rituximab - Azathioprine - cyclosporine or mycophenolate (MMF; mycophenolate mofetil) - vincristine or cyclophosphamide - danazol - dapsone - Alemtuzumab ? Women of childbearing potential must have a negative urine or serum pregnancy test within 28 days prior to the start of administration of the test drug. ? It must be a person who voluntarily or legally consented in writing to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: ? Pregnant women, lactating women ? Those who are allergic to bortezomib. ? Those with Grade 2 or higher peripheral neuropathy requiring drug treatment. ? Those with severe or uncontrolled active infection. ? In case of significant immunoglobulin decrease in immunoglobulin profile. ? HBV, HCV carrier or HIV patient. However, it is possible to participate if it is stably maintained with antiviral treatment, and if it is judged that it is possible to participate in clinical trials along with antiviral treatment and prevention in the opinion of experts. ? Those who are currently undergoing chemotherapy. ? Patients whose bone marrow has not recovered after chemotherapy or whose cause of thrombocytopenia other than immunosuppression has been confirmed by bone marrow examination, such as thrombocytopenia due to intramedullary abnormalities. However, if the presence of antiplatelet antibodies is proven and thrombocytopenia due to immune destruction is strongly suspected clinically, registration is possible even if there are other causes of thrombocytopenia. ? Those who may become pregnant. However, women of childbearing age who have not undergone sterilization can participate in the clinical trial only if the pregnancy test is negative, and effective contraceptive methods must be maintained throughout the entire trial period. (After menopause, a woman must have been amenorrhea for at least 12 months to be considered non-fertile.) ? Those who are currently participating in other clinical trials. ? A person who is considered by the researcher to be inappropriate to participate in a clinical trial. ? Those with inappropriate organ functions. - Total Bilirubin > 3 x ULN - Creatinine > 1.5 x ULN - Liver function test AST(SGOT) and ALT(SGPT) > 3 x ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet response rate at week 9 | — |
Secondary
| Measure | Time frame |
|---|---|
| Platelet transfusion frequency/month (compared to baseline). | — |
Countries
Korea, Republic of
Contacts
Public ContactDONG-YEOP SHIN
Seoul National University Hospital
Outcome results
None listed