Low-dose Rituximab and High-dose Dexamethasone as First Line Treatment for ITP

Hospital Universitario Dr. Jose E. Gonzalez

Status and phase: Completed; Phase 2

Conditions: Immune Thrombocytopenic Purpura

Treatments: Drug: Rituximab and dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01107951

Rituximab in PTI 001

Details and patient eligibility

About

The purpose of this study is to determine the response rate and response duration with the combination of low-dose rituximab and high-dose dexamethasone in the treatment of adult immune thrombocytopenic purpura.

Full description

ITP is an autoimmune disorder characterized by formation of autoantibodies against platelet antigens leading platelet destruction and bleeding. 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. Rituximab, a chimeric anti-CD20 monoclonal antibody, has been shown to be effectively raise the platelet count in some patients with ITP and there is clinical and biological evidence to suggest that, if given early, rituximab may prevent ITP relapses. Rituximab 375 mg/m2 weekly for four weeks has significant activity in patients with immune thrombocytopenia. Furthermore, using lower dose rituximab the level of B-cell depletion and the response rates appear similar to those previously observed with standard dosages in a population of ITP.

The purpose of this study is to determine the response rate and response duration with the combination of low-dose rituximab (100mg IV days 1,8, 15 and 22) and high-dose dexamethasone (40mg PO days 1,2,3,4) in untreated adult patients immune thrombocytopenic purpura.

A complete platelet response is defined as an increase in platelet counts to >150×109/L on two consecutive occasions. A partial response is defined as an increase in the platelet count to between 50 and 150×109/L on two consecutive occasions, 1 week apart. Duration of response is considered from the day of the initial infusion to the first time of relapse (platelet count <30×109/L)or to time of analysis.

Enrollment: 21 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically confirmed immune thrombocytopenic purpura (ITP) Platelet count less than 30,000/mm3 on two occasions. Platelets >30000/mm3 with bleeding.
• Normal to increased numbers of megakaryocytes on bone marrow examination in patients ≥ 60 years
• Subject is ≥ 18 years
• Subject has signed and dated written informed consent.
• No sepsis or fever
• No active infection requiring therapy
• No active chronic viral infection
• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Exclusion criteria

• Performance status above or equal to 2.
• Previous treatment with rituximab
• Immunosuppressive treatment within the last month
• Previous splenectomy
• Presence of malignant haematological disease
• Connective tissue disease
• Autoimmune hemolytic anemia
• Pregnancy and lactation
• Not willing to participate in the study.
• Expected survival of < 2 years
• Known intolerance to murine antibodies.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Rituximab -dexamethasone

Other group

Description:

only one arm receive four doses weekly rituximab and four dosis daily dexamethasona

Treatment:

Drug: Rituximab and dexamethasone