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

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:

Genetics Home Reference related topics: thrombotic thrombocytopenic purpura

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone sodium phosphate Rituximab

U.S. FDA Resources

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

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):

Gudbrandsdottir S, Birgens HS, Frederiksen H, Jensen BA, Jensen MK, Kjeldsen L, Klausen TW, Larsen H, Mourits-Andersen HT, Nielsen CH, Nielsen OJ, Plesner T, Pulczynski S, Rasmussen IH, Rønnov-Jessen D, Hasselbalch HC. Rituximab and dexamethasone vs dexamethasone monotherapy in newly diagnosed patients with primary immune thrombocytopenia. Blood. 2013 Mar 14;121(11):1976-81. doi: 10.1182/blood-2012-09-455691. Epub 2013 Jan 4.

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
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases

Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Rituximab
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on May 22, 2013