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)
Overview
- Phase
- Phase 3
- Intervention
- Dexamethasone and Rituximab
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Sponsor
- Copenhagen University Hospital at Herlev
- Enrollment
- 155
- Locations
- 10
- Primary Endpoint
- Number of patients with sustained partial response after 6 months
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Forskningsenheden
Forskningsenhed
Copenhagen University Hospital at Herlev
Eligibility Criteria
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.
Arms & Interventions
1
Combination therapy with Dexamethasone and Rituximab
Intervention: Dexamethasone and Rituximab
2
Dexamethasone as monotherapy
Intervention: Dexamethasone
Outcomes
Primary Outcomes
Number of patients with sustained partial response after 6 months
Time Frame: 6 months
Secondary Outcomes
- 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)