The Efficacy of Dexamethasone Versus Dexamethasone Combined With Rituximab in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP)

Study Overview
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Brief Summary
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In this study we want to investigate if combination therapy with rituximab (R) + dexamethasone (DXM) is superior to monotherapy with DXM in patients with newly diagnosed idiopathic thrombocytopenic purpura (ITP). Before treatment molecular studies - gene expression profiling - are performed to characterize at the molecular level those patients responding adequately to the treatment as compared to those obtaining a minor or no responses. The hypothesis is that combination therapy is superior to monotherapy as defined above. Using gene expression studies up-front the hypothesis is that this method may be able to predict the response to treatment.

Official Title
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A Randomised Phase III Study of the Efficacy of High Dose Dexamethasone Versus High Dose Dexamethasone in Combination With Rituximab (MabThera®)in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP)

Conditions
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Idiopathic Thrombocytopenic Purpura

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Dexamethasone and Rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or over Diagnosis = ITP + platelet count above or equal to 25 Mia/l or platelet count above or equal to 50 Mia/l and bleeding from the mucous membranes. Adequate contraceptive measures within the last 3 months for women of childbearing potential. Exclusion Criteria: Performance status above or equal to 2 Previous treatment with rituximab Immunosuppressive treatment within the last month except for not previously treated patients Other serious disease Pregnant women and nursing mothers Contraindication for rituximab treatment. Active infection requiring antibiotic treatment.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: 1<br>Combination therapy with Dexamethasone and Rituximab | Drug: Dexamethasone and Rituximab<br>* Dexamethasone tablets: 40 mgs/day for four days Rituximab iv 375 mg/m^2 weekly, a total of four times. Administered on day 2 (i.e. the patient has been treated with Dexamethasone for one day)<br>|
| Active Comparator: 2<br>Dexamethasone as monotherapy | Drug: Dexamethasone<br>* Dexamethasone tablets: 40 mg/day for four days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with sustained partial response after 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rates in the 2 arms at day 7, 10, 14,21, 28, month 2 - 12, year 2 - 5 |  | day 7, 10, 14,21, 28, month 2 - 12, year 2 - 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ITP-Rituximab-dexamethasone