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

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Rituximab

Criteria

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.