Rituximab, Eltrombopag and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

• Status: Unknown status
• Trial end date: 2017-09-01
• 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, eltrombopag and high-dose dexamethasone.

• 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 (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