Rituximab, Eltrombopag and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-09-30

Brief Summary

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The purpose of this study is to determine the response rate and response duration with the combination of low-dose rituximab, eltrombopag and high-dose dexamethasone.

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Detailed Description

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Immune thrombocytopenia is an autoimmune disorder characterized by formation of autoantibodies against platelet antigens leading platelet destruction.

Corticosteroids increase the platelet count in about 80 percent of patients. However, many patients have a relapse when the dose of corticosteroid is reduced. Debilitating side effects are common in patients who require long-term corticosteroid therapy to maintain the platelet count. Eltrombopag, it is a small molecule agonist of the c-mpl (TpoR) receptor, which is the physiological target of the hormone thrombopoietin, has been shown to be effectively raise the platelet count in adult patients (aged 18 years and over) who have had their spleen removed or where splenectomy is not an option and have received prior treatment with corticosteroids or immunoglobulins, and these medicines did not work (refractory ITP). There are a few case reports where eltrombopag was an option as first line treatment for IT.

The purpose of this study is to determine the response rate and response duration with the combination of rituximab (100 mg weekly four weeks), eltrombopag (50mg PO once a day, day 1-28) and high-dose dexamethasone (40mg PO days 1-4) in untreated adult patients with \<30\*109/L platelet count diagnosed with immune thrombocytopenia.

A complete response is defined as an increase in platelet counts to \>150×109/L on two consecutive occasions. A clinical response is defined as an increase in the platelet count between \>30×109/L on two consecutive measures and no bleeding. Duration of response is considered from the day of the initial administration to the first time of relapse (platelet count \<30×109/L) or to time of analysis Patients will be evaluated each week during 4 weeks and then every month for at least 6 months.

Conditions

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Immune Thrombocytopenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rituximab, eltrombopag and dexamethasone

Each patient will receive Rituximab 100 mg weekly days 1, 7, 14, 21 Eltrombopag 50 mg PO days 1-28 Dexamethasone 40 mg IV/PO days 1-4

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

Rituximab 100 mg weekly days 1, 7, 14, 21

Eltrombopag

Intervention Type DRUG

Eltrombopag 50 mg PO days 1-28

Dexamethasone

Intervention Type DRUG

Dexamethasone 40 mg IV/PO days 1-4

Interventions

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Rituximab

Rituximab 100 mg weekly days 1, 7, 14, 21

Intervention Type DRUG

Eltrombopag

Eltrombopag 50 mg PO days 1-28

Intervention Type DRUG

Dexamethasone

Dexamethasone 40 mg IV/PO days 1-4

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinically confirmed immune thrombocytopenic (IT) Platelet count less than 30,000/mm3 on two ocasionts with bleeding.
* Subject ≥ 16 years
* Subject has signed and dated written informed consent.
* No sepsis or fever or active infection
* Not pregnant or nursing

Exclusion Criteria

* Previous treatment (only corticosteroids at dose or prednisone equivalent of 300 mg)
* Performance status above or equal to 2.
* Pregnancy and lactation
* Previous splenectomy
* Connective tissue disease
* Autoimmune hemolytic anemia
* Relapse

Minimum Eligible Age

16 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No