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

Primary Purpose

Idiopathic Thrombocytopenic Purpura

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Dexamethasone
Dexamethasone and Rituximab
Sponsored by
Copenhagen University Hospital at Herlev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Thrombocytopenic Purpura focused on measuring ITP-Rituximab-dexamethasone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Aalborg Hospital
  • Copenhagen University Hospital Rigshospitalet
  • Esbjerg Hospital
  • Copenhagen University Hospital Herlev, Department of Haematology
  • Regional Hospital Holstebro
  • Naestved Hospital
  • Odense University Hospital
  • Roskilde Hospital
  • Vejle Hospital
  • Viborg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Combination therapy with Dexamethasone and Rituximab

Dexamethasone as monotherapy

Outcomes

Primary Outcome Measures

Number of patients with sustained partial response after 6 months

Secondary Outcome Measures

Remission rates in the 2 arms at day 7, 10, 14,21, 28, month 2 - 12, year 2 - 5

Full Information

First Posted
May 26, 2009
Last Updated
September 9, 2019
Sponsor
Copenhagen University Hospital at Herlev
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1. Study Identification

Unique Protocol Identification Number
NCT00909077
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 2004 (Actual)
Primary Completion Date
June 1, 2012 (Actual)
Study Completion Date
August 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Copenhagen University Hospital at Herlev

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Thrombocytopenic Purpura
Keywords
ITP-Rituximab-dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Combination therapy with Dexamethasone and Rituximab
Arm Title
2
Arm Type
Active Comparator
Arm Description
Dexamethasone as monotherapy
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone tablets: 40 mg/day for four days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone and Rituximab
Intervention Description
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)
Primary Outcome Measure Information:
Title
Number of patients with sustained partial response after 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans C Hasselbalch, MD
Organizational Affiliation
Copenhagen University Hospital Herlev, Department of Haematology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg Hospital
City
Aalborg
ZIP/Postal Code
DK-9000
Country
Denmark
Facility Name
Copenhagen University Hospital Rigshospitalet
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
Facility Name
Esbjerg Hospital
City
Esbjerg
ZIP/Postal Code
DK-6700
Country
Denmark
Facility Name
Copenhagen University Hospital Herlev, Department of Haematology
City
Herlev
ZIP/Postal Code
DK-2730
Country
Denmark
Facility Name
Regional Hospital Holstebro
City
Holstebro
ZIP/Postal Code
DK-7500
Country
Denmark
Facility Name
Naestved Hospital
City
Naestved
ZIP/Postal Code
DK-4700
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
Roskilde Hospital
City
Roskilde
ZIP/Postal Code
DK-4000
Country
Denmark
Facility Name
Vejle Hospital
City
Vejle
ZIP/Postal Code
DK-7100
Country
Denmark
Facility Name
Viborg Hospital
City
Viborg
ZIP/Postal Code
DK-8800
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
23293082
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.
Results Reference
derived

Learn more about this trial

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

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