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

Idiopathic Thrombocytopenic Purpura Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909077
• Other study ID #: ITP-Rituximab-DXM
• Status: Completed
• Phase: Phase 3
• Start date: August 2004
• Est. completion date: August 1, 2017

Study information

• Verified date: September 2019
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: August 1, 2017
• Est. primary completion date: June 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Idiopathic Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Drug:
• Dexamethasone
Dexamethasone tablets: 40 mg/day for four days
• 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)

Locations

Country	Name	City	State
Denmark	Aalborg Hospital	Aalborg
Denmark	Copenhagen University Hospital Rigshospitalet	Copenhagen
Denmark	Esbjerg Hospital	Esbjerg
Denmark	Copenhagen University Hospital Herlev, Department of Haematology	Herlev
Denmark	Regional Hospital Holstebro	Holstebro
Denmark	Naestved Hospital	Naestved
Denmark	Odense University Hospital	Odense
Denmark	Roskilde Hospital	Roskilde
Denmark	Vejle Hospital	Vejle
Denmark	Viborg Hospital	Viborg

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with sustained partial response after 6 months		6 months
Secondary	Remission rates in the 2 arms at day 7, 10, 14,21, 28, month 2 - 12, year 2 - 5		day 7, 10, 14,21, 28, month 2 - 12, year 2 - 5