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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev Identifier:
First received: May 26, 2009
Last updated: February 11, 2015
Last verified: February 2015

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 Intervention Phase
Idiopathic Thrombocytopenic Purpura Drug: Dexamethasone Drug: Dexamethasone and Rituximab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:

Further study details as provided by Copenhagen University Hospital at Herlev:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: August 2004
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

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
Study First Received: May 26, 2009
Last Updated: February 11, 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
Dexamethasone 21-phosphate
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 processed this record on June 23, 2017