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

Last updated: September 9, 2019
Sponsor: Copenhagen University Hospital at Herlev
Overall Status: Completed

Phase

3

Condition

Anemia

Immune Thrombocytopenia (Itp)

Immune (Idiopathic) Thrombocytopenic Purpura (Itp)

Treatment

N/A

Clinical Study ID

NCT00909077
ITP-Rituximab-DXM
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years or over

  • Diagnosis = ITP + platelet count above or equal to 25 Mia/l or platelet count above orequal to 50 Mia/l and bleeding from the mucous membranes.

  • Adequate contraceptive measures within the last 3 months for women of childbearingpotential.

Exclusion

Exclusion Criteria:

  • Performance status above or equal to 2

  • Previous treatment with rituximab

  • Immunosuppressive treatment within the last month except for not previously treatedpatients

  • Other serious disease

  • Pregnant women and nursing mothers

  • Contraindication for rituximab treatment.

  • Active infection requiring antibiotic treatment.

Study Design

Total Participants: 155
Study Start date:
August 01, 2004
Estimated Completion Date:
August 01, 2017

Connect with a study center

  • Aalborg Hospital

    Aalborg, DK-9000
    Denmark

    Site Not Available

  • Copenhagen University Hospital Rigshospitalet

    Copenhagen, DK-2100
    Denmark

    Site Not Available

  • Esbjerg Hospital

    Esbjerg, DK-6700
    Denmark

    Site Not Available

  • Copenhagen University Hospital Herlev, Department of Haematology

    Herlev, DK-2730
    Denmark

    Site Not Available

  • Regional Hospital Holstebro

    Holstebro, DK-7500
    Denmark

    Site Not Available

  • Naestved Hospital

    Naestved, DK-4700
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense, DK-5000
    Denmark

    Site Not Available

  • Roskilde Hospital

    Roskilde, DK-4000
    Denmark

    Site Not Available

  • Vejle Hospital

    Vejle, DK-7100
    Denmark

    Site Not Available

  • Viborg Hospital

    Viborg, DK-8800
    Denmark

    Site Not Available

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