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

Sponsor

Copenhagen University Hospital at Herlev (Other)

Overall Status

Completed

CT.gov ID

NCT00909077

Collaborator

(none)

155

Enrollment

Locations

Arms

156

Actual Duration (Months)

15.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Thrombocytopenic Purpura	Drug: Dexamethasone Drug: Dexamethasone and Rituximab	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

155 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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)

Actual Study Start Date :

Aug 1, 2004

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Number of patients with sustained partial response after 6 months [6 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Aalborg Hospital	Aalborg	Denmark	DK-9000
2	Copenhagen University Hospital Rigshospitalet	Copenhagen	Denmark	DK-2100
3	Esbjerg Hospital	Esbjerg	Denmark	DK-6700
4	Copenhagen University Hospital Herlev, Department of Haematology	Herlev	Denmark	DK-2730
5	Regional Hospital Holstebro	Holstebro	Denmark	DK-7500
6	Naestved Hospital	Naestved	Denmark	DK-4700
7	Odense University Hospital	Odense	Denmark	DK-5000
8	Roskilde Hospital	Roskilde	Denmark	DK-4000
9	Vejle Hospital	Vejle	Denmark	DK-7100
10	Viborg Hospital	Viborg	Denmark	DK-8800