Romiplostim, Rituximab and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

• Status: Recruiting
• Trial end date: 2022-11-01
• 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, romiplostim and high-dose dexamethasone.

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

Details

• Lead Sponsor: David Gomez Almaguer
• Treatments: Dexamethasone; Rituximab

Criteria

Inclusion Criteria:

• Clinically confirmed immune thrombocytopenia (IT) Platelet count less than 30,000/mm3 on two occasions.

• Subject ≥ 16 years

• Subject has signed and dated written informed consent.

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

• Active infection, sepsis or fever

• Positive for hepatitis B virus or hepatitis C virus or human immunodeficiency virus.