The Study of Different Dose Rituximab in the Treatment of ITP

Study Overview
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Brief Summary
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The project was undertaking by Qilu Hospital of Shandong University in China. In order to compare the efficacy, safety and response duration of different dose of rituximab in patients primary immune thrombocytopenia(pITP).

Detailed Description
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62 patients with pITP who had failed to respond to glucocorticosteroids were randomly divided into 2 groups: group A(n = 32) and group B(n = 30). In group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22). In group B, Rituximab was given with a single dose of 375mg/m2. The clinical effect, onset time, duration of efficacy and adverse reactions were observed to compare the efficacy and safety of two different plans.

Official Title
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The Clinical Randomized Controlled Study of Different Dose Rituximab in the Treatment of Primary Immune Thrombocytopenia

Conditions
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Purpura, Thrombocytopenic, Idiopathic, Immune Thrombocytopenia

Intervention / Treatment
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* Drug: Rituximab
* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the diagnostic criteria for immune thrombocytopenia. Male or female, between the ages of 10   70 years. Normal glucocorticoid therapy is ineffective or effective but the maintenance dose is large, without immunosuppressive therapy or immunosuppressive treatment ineffective To show a platelet count < 30×10^9/L, or with bleeding manifestations. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2 Exclusion Criteria: Current HIV infection or hepatitis B virus or hepatitis C virus infections. Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test. Patients who are deemed unsuitable for the study by the investigator.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>In group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22). | Drug: Rituximab<br>* given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22)<br>* Other names: Mabthera;|
| Experimental: group B<br>In group B, Rituximab was given with a single dose of 375mg/m2 | Drug: Rituximab<br>* given with a single dose of 375mg/m2<br>* Other names: Mabthera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of platelet response(continuous response rate) | Complete Response:a sustained (≥ 3 months) platelet count≥100×10^9/L;response: a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia;No response (NR): platelet count < 30 × 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart. | up to 1 year per subject | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| therapy associated adverse events | The number and frequency of therapy associated adverse events | up to 1 year per subject | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thrombocytopenia, Immune Thrombocytopenia, purpura