Clinical trial NCT00909077: The Efficacy of Dexamethasone Versus Dexamethasone Combined With Rituximab in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Thrombocytopenic Purpura
Keywords: ITP-Rituximab-dexamethasone
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2009-05-27
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of patients with sustained partial response after 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Remission rates in the 2 arms at day 7, 10, 14,21, 28, month 2 - 12, year 2 - 5
timeFrame: day 7, 10, 14,21, 28, month 2 - 12, year 2 - 5
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Hospital
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital Rigshospitalet
city: Esbjerg
country: Denmark
facility: Esbjerg Hospital
city: Herlev
country: Denmark
facility: Copenhagen University Hospital Herlev, Department of Haematology
city: Holstebro
country: Denmark
facility: Regional Hospital Holstebro
city: Naestved
country: Denmark
facility: Naestved Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Roskilde
country: Denmark
facility: Roskilde Hospital
city: Vejle
country: Denmark
facility: Vejle Hospital
city: Viborg
country: Denmark
facility: Viborg Hospital
Study officials:
affiliation: Copenhagen University Hospital Herlev, Department of Haematology
name: Hans C Hasselbalch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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, Ronnov-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.