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

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00909077

Enrollment

155

Registered

2009-05-27

Start date

2004-08-31

Completion date

2017-08-01

Last updated

2019-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Thrombocytopenic Purpura

Keywords

ITP-Rituximab-dexamethasone

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.

Interventions

DRUGDexamethasone

Dexamethasone tablets: 40 mg/day for four days

DRUGDexamethasone 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026