Low-dose Rituximab Regimens in Chinese Adult Patients With Immune Thrombocytopenia (NCT01719692) | Clinical Trial Compass
CompletedNot Applicable
Low-dose Rituximab Regimens in Chinese Adult Patients With Immune Thrombocytopenia
China100 participantsStarted 2012-10
Plain-language summary
A comparative study with rituximab (100 mg weekly for 4 weeks and 375mg/m2 for once) shows low dose rituximab may be a useful alternative therapy in patients with ITP.The aim of this study is to compare the efficacy and tolerability of two different regimens of low doses rituximab for the treatment of adult patients with ITP.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-60 years old;
* Diagnosis of primary immune thrombocytopenia according to the guidelines of American Society of Hematology for at least 3 months before inclusion;
* Platelet count \<30Ă—109/L (measured at least twice during the screening, with at least a 1-week interval);
* Failed or dependent on or relapsed after previous treatment with glucocorticoid;
* If on glucocorticoid maintenance therapy, dose ≤0.5 mg/kg prednisone or equivalent and stabilised for at least 4 weeks;
* Drugs such as azathioprine, danazol, cyclosporine A, tacrolimus, and sirolimus stopped for at least 4 weeks;
* Splenectomy more than 6 months previously;
* Previous rescue therapy of ITP (including methylprednisolone, platelet transfusion and IVIG) completed at least 2 weeks before the first administration;
* Liver and kidney function (including alanine aminotransferase, aspartate aminotransferase, total bilirubin, serum creatine, urea nitrogen, etc.) less than 1.5 times the upper limit of normal value;
* Eastern Cooperative Oncology Group performance status ≤2;
* Cardiac function classification (New York Heart Association) ≤2;
* Understand the research procedure and voluntarily sign a written informed consent form.
Exclusion Criteria:
* Patients with secondary thrombocytopenia (including myelodysplastic syndrome, aplastic anemia, common variant immunodeficiency disease, hereditary thrombocytopenia, drug-induced thrombocytopenia, pseudothrombocytopenia, connective tissue dis…
What they're measuring
1
Overall response rate at week 12
Timeframe: Patients will be followed for 6 months at least after Rituximab treatment.
Trial details
NCT IDNCT01719692
SponsorInstitute of Hematology & Blood Diseases Hospital, China