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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.
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT00909077
First received: May 26, 2009
Last updated: August 22, 2012
Last verified: December 2011
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2004
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2012 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909077

Locations
Denmark
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
Investigators
Principal Investigator: Hans C Hasselbalch, MD Copenhagen University Hospital Herlev, Department of Haematology
  More Information

No publications provided by Copenhagen University Hospital at Herlev

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT00909077     History of Changes
Other Study ID Numbers: ITP-Rituximab-DXM
Study First Received: May 26, 2009
Last Updated: August 22, 2012
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Copenhagen University Hospital at Herlev:
ITP-Rituximab-dexamethasone

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Autoimmune Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Diseases
Hemorrhage
Hemorrhagic Disorders
Immune System Diseases
Pathologic Processes
Signs and Symptoms
Skin Manifestations
Thrombocytopenia
Thrombotic Microangiopathies
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Rituximab
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on November 25, 2014