Overview

This trial is active, not recruiting.

Condition idiopathic thrombocytopenic purpura
Treatments dexamethasone, dexamethasone and rituximab
Phase phase 3
Sponsor Copenhagen University Hospital at Herlev
Start date August 2004
End date June 2017
Trial size 200 participants
Trial identifier NCT00909077, ITP-Rituximab-DXM

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Combination therapy with Dexamethasone and Rituximab
dexamethasone and rituximab
Dexamethasone tablets: 40 mgs/day for four days Rituximab iv 375 mg/m^2 weekly, a total of four times. Administered on day 2 (i.e. the patient has been treated with Dexamethasone for one day)
(Active Comparator)
Dexamethasone as monotherapy
dexamethasone
Dexamethasone tablets: 40 mg/day for four days

Primary Outcomes

Measure
Number of patients with sustained partial response after 6 months
time frame: 6 months

Secondary Outcomes

Measure
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

Eligibility Criteria

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Copenhagen University Hospital at Herlev.