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

September 9, 2019 updated by: Forskningsenheden, Copenhagen University Hospital at Herlev

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, DK-9000
        • Aalborg Hospital
      • Copenhagen, Denmark, DK-2100
        • Copenhagen University Hospital Rigshospitalet
      • Esbjerg, Denmark, DK-6700
        • Esbjerg Hospital
      • Herlev, Denmark, DK-2730
        • Copenhagen University Hospital Herlev, Department of Haematology
      • Holstebro, Denmark, DK-7500
        • Regional Hospital Holstebro
      • Naestved, Denmark, DK-4700
        • Naestved Hospital
      • Odense, Denmark, DK-5000
        • Odense University Hospital
      • Roskilde, Denmark, DK-4000
        • Roskilde Hospital
      • Vejle, Denmark, DK-7100
        • Vejle Hospital
      • Viborg, Denmark, DK-8800
        • Viborg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Combination therapy with Dexamethasone and Rituximab
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)
Active Comparator: 2
Dexamethasone as monotherapy
Drug: Dexamethasone
Dexamethasone tablets: 40 mg/day for four days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with sustained partial response after 6 months
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
day 7, 10, 14,21, 28, month 2 - 12, year 2 - 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital at Herlev

Investigators

  • Principal Investigator: Hans C Hasselbalch, MD, Copenhagen University Hospital Herlev, Department of Haematology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2004

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

May 26, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (Estimate)

May 27, 2009

Study Record Updates

Last Update Posted (Actual)

September 10, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITP-Rituximab-DXM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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