The Efficacy of Dexamethasone Versus Dexamethasone Combined With Rituximab in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP)
This trial is active, not recruiting.
|Condition||idiopathic thrombocytopenic purpura|
|Treatments||dexamethasone, dexamethasone and rituximab|
|Sponsor||Copenhagen University Hospital at Herlev|
|Start date||August 2004|
|End date||June 2017|
|Trial size||200 participants|
|Trial identifier||NCT00909077, ITP-Rituximab-DXM|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Aalborg, Denmark||Aalborg Hospital||no longer recruiting|
|Copenhagen, Denmark||Copenhagen University Hospital Rigshospitalet||no longer recruiting|
|Esbjerg, Denmark||Esbjerg Hospital||no longer recruiting|
|Herlev, Denmark||Copenhagen University Hospital Herlev, Department of Haematology||no longer recruiting|
|Holstebro, Denmark||Regional Hospital Holstebro||no longer recruiting|
|Naestved, Denmark||Naestved Hospital||no longer recruiting|
|Odense, Denmark||Odense University Hospital||no longer recruiting|
|Roskilde, Denmark||Roskilde Hospital||no longer recruiting|
|Vejle, Denmark||Vejle Hospital||no longer recruiting|
|Viborg, Denmark||Viborg Hospital||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
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
Male or female participants at least 18 years old.
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.
|Official title||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)|
|Principal investigator||Hans C Hasselbalch, MD|
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