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

Conditions

• Idiopathic Thrombocytopenic Purpura

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Aug 31, 2004

Status verified

Sep 2019

Primary completion

Jun 1, 2012

Completion

Aug 1, 2017

Study Design

Enrollment

155 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 1
  Combination therapy with Dexamethasone and Rituximab
• Active Comparator: 2
  Dexamethasone as monotherapy

Primary Outcome Measure

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