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

Copenhagen University Hospital at Herlev

Status and phase

Completed

Phase 3

Conditions

Idiopathic Thrombocytopenic Purpura

Treatments

Drug: Dexamethasone and Rituximab

Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT00909077

ITP-Rituximab-DXM

Details and patient eligibility

About

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.

Enrollment

155 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.