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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00909077
Recruitment Status : Unknown
Verified February 2015 by Copenhagen University Hospital at Herlev.
Recruitment status was:  Active, not recruiting
First Posted : May 27, 2009
Last Update Posted : February 12, 2015
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev

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.

Condition or disease Intervention/treatment Phase
Idiopathic Thrombocytopenic Purpura Drug: Dexamethasone Drug: Dexamethasone and Rituximab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : August 2004
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

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

Primary Outcome Measures :
  1. Number of patients with sustained partial response after 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00909077

Aalborg Hospital
Aalborg, Denmark, DK-9000
Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark, DK-2100
Esbjerg Hospital
Esbjerg, Denmark, DK-6700
Copenhagen University Hospital Herlev, Department of Haematology
Herlev, Denmark, DK-2730
Regional Hospital Holstebro
Holstebro, Denmark, DK-7500
Naestved Hospital
Naestved, Denmark, DK-4700
Odense University Hospital
Odense, Denmark, DK-5000
Roskilde Hospital
Roskilde, Denmark, DK-4000
Vejle Hospital
Vejle, Denmark, DK-7100
Viborg Hospital
Viborg, Denmark, DK-8800
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Principal Investigator: Hans C Hasselbalch, MD Copenhagen University Hospital Herlev, Department of Haematology

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Copenhagen University Hospital at Herlev Identifier: NCT00909077     History of Changes
Other Study ID Numbers: ITP-Rituximab-DXM
First Posted: May 27, 2009    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: February 2015

Keywords provided by Copenhagen University Hospital at Herlev:

Additional relevant MeSH terms:
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents