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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2017-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Idiopathic Thrombocytopenic Purpura

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Combination therapy with Dexamethasone and Rituximab

Group Type ACTIVE_COMPARATOR

Dexamethasone and Rituximab

Intervention Type DRUG

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)

2

Dexamethasone as monotherapy

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Dexamethasone tablets: 40 mg/day for four days

Interventions

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Dexamethasone

Dexamethasone tablets: 40 mg/day for four days

Intervention Type DRUG

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)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No