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

NCT00909077 | Completed Phase 3

• 1 other identifier: ITP-Rituximab-DXM
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 10

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.

Conditions

Idiopathic Thrombocytopenic Purpura

Keywords

ITP-Rituximab-dexamethasone

Outcome Measures

Primary Outcomes (1)

• Number of patients with sustained partial response after 6 months

  6 months

Secondary Outcomes (1)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Combination therapy with Dexamethasone and Rituximab

Drug: Dexamethasone and Rituximab

2

ACTIVE COMPARATOR

Dexamethasone as monotherapy

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Dexamethasone tablets: 40 mg/day for four days

2

Dexamethasone and Rituximab DRUG

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)

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead

Study Sites (10)

Aalborg Hospital

Aalborg, DK-9000, Denmark

Location

Copenhagen University Hospital Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

Esbjerg Hospital

Esbjerg, DK-6700, Denmark

Location

Copenhagen University Hospital Herlev, Department of Haematology

Herlev, DK-2730, Denmark

Location

Regional Hospital Holstebro

Holstebro, DK-7500, Denmark

Location

Naestved Hospital

Næstved, DK-4700, Denmark

Location

Odense University Hospital

Odense, DK-5000, Denmark

Location

Roskilde Hospital

Roskilde, DK-4000, Denmark

Location

Vejle Hospital

Vejle, DK-7100, Denmark

Location

Viborg Hospital

Viborg, DK-8800, Denmark

Location

Related Publications (1)

• 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.

  PMID: 23293082 DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Dexamethasone; Rituximab

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Hans C Hasselbalch, MD

  Copenhagen University Hospital Herlev, Department of Haematology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Forskningsenhed

Study Record Dates

• First Submitted: May 26, 2009
• First Posted: May 27, 2009
• Study Start: August 1, 2004
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2017
• Last Updated: September 10, 2019

Record last verified: 2019-09

Locations

DK (10)