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

Phase 3

Completed

• Conditions: Idiopathic Thrombocytopenic Purpura
• Interventions: Drug: Dexamethasone and Rituximab; Drug: Dexamethasone

• Registration Number: NCT00909077
• Lead Sponsor: Copenhagen University Hospital at Herlev

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2009-05-26
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-27
• Primary Completion: 2012-06-01
• Study Completion: 2017-08-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Dexamethasone and Rituximab	Combination therapy with Dexamethasone and Rituximab
2	Dexamethasone	Dexamethasone as monotherapy

Primary Outcome Measures

Name	Time	Method
Number of patients with sustained partial response after 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

Esbjerg Hospital; 🇩🇰 Esbjerg, Denmark

Copenhagen University Hospital Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Copenhagen University Hospital Herlev, Department of Haematology; 🇩🇰 Herlev, Denmark

Regional Hospital Holstebro; 🇩🇰 Holstebro, Denmark

Naestved Hospital; 🇩🇰 Naestved, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Viborg Hospital; 🇩🇰 Viborg, Denmark

Aalborg Hospital; 🇩🇰 Aalborg, Denmark

Vejle Hospital; 🇩🇰 Vejle, Denmark

Roskilde Hospital; 🇩🇰 Roskilde, Denmark