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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
155
Dexamethasone tablets: 40 mg/day for four days
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)
Aalborg Hospital
Aalborg, Denmark
Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark
Esbjerg Hospital
Esbjerg, Denmark
Copenhagen University Hospital Herlev, Department of Haematology
Herlev, Denmark
Regional Hospital Holstebro
Holstebro, Denmark
Naestved Hospital
Næstved, Denmark
Odense University Hospital
Odense, Denmark
Roskilde Hospital
Roskilde, Denmark
Vejle Hospital
Vejle, Denmark
Viborg Hospital
Viborg, Denmark
Number of patients with sustained partial response after 6 months
Time frame: 6 months
Remission rates in the 2 arms at day 7, 10, 14,21, 28, month 2 - 12, year 2 - 5
Time frame: day 7, 10, 14,21, 28, month 2 - 12, year 2 - 5
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