KCT0007758
Not yet recruiting
未知
A phase 2 study to investigate efficacy and safety evaluation of bortezomib in patients with relapsed/refractory immune thrombocytopenia (BORRELIA)
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
- Sponsor
- Seoul National University Hospital
- Enrollment
- 29
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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.
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.
Outcomes
Primary Outcomes
Not specified
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