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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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 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.

Detailed Summary:
Sponsor: Copenhagen University Hospital at Herlev

Current Primary Outcome: Number of patients with sustained partial response after 6 months [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

Original Secondary Outcome: Same as current

Information By: Copenhagen University Hospital at Herlev

Dates:
Date Received: May 26, 2009
Date Started: August 2004
Date Completion: December 2017
Last Updated: February 11, 2015
Last Verified: February 2015