Rituximab, Eltrombopag and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

Immune Thrombocytopenia Clinical Trial

Official title:

Low-dose Rituximab in Combination With Eltrombopag and High-dose Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02834286
• Other study ID #: HE14-021
• Status: Recruiting
• Phase: Phase 2
• First received: July 1, 2016
• Last updated: July 12, 2016
• Start date: March 2015
• Est. completion date: September 2017

Study information

• Verified date: July 2016
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: David Gómez, MD
• Phone: +5583486136
• Email: dgomezalmaguer[@]gmail.com
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 90 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• Rituximab
Rituximab 100 mg weekly days 1, 7, 14, 21
• Eltrombopag
Eltrombopag 50 mg PO days 1-28
• Dexamethasone
Dexamethasone 40 mg IV/PO days 1-4

Locations

Country	Name	City	State
Mexico	Servicio de Hematología, Hospital Universitario "Dr. José Eleuterio González", Universidad Autónoma de Nuevo León	Monterrey	Nuevo León

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

Gómez-Almaguer D, Herrera-Rojas MA, Jaime-Pérez JC, Gómez-De León A, Cantú-Rodríguez OG, Gutiérrez-Aguirre CH, Tarín-Arzaga L, Hernández-Reyes J, Ruiz-Arguelles GJ. Eltrombopag and high-dose dexamethasone as frontline treatment of newly diagnosed immune t — View Citation

Gómez-Almaguer D, Tarín-Arzaga L, Moreno-Jaime B, Jaime-Pérez JC, Ceballos-López AA, Ruiz-Argüelles GJ, Ruiz-Delgado GJ, Cantú-Rodríguez OG, Gutiérrez-Aguirre CH, Sánchez-Cárdenas M. High response rate to low-dose rituximab plus high-dose dexamethasone as — View Citation

González-López TJ, Alvarez-Román MT, Pascual C, Sánchez-González B, Fernández-Fuentes F, Jarque I, Pérez-Rus G, Pérez-Crespo S, Bernat S, Hernández-Rivas JA, Andrade MM, Cortés M, Gómez-Nuñez M, Olivera P, Martínez-Robles V, Fernández-Rodríguez A, Fuertes — View Citation

Kim YK, Lee SS, Jeong SH, Ahn JS, Yang DH, Lee JJ, Kim HJ. Efficacy and safety of eltrombopag in adult refractory immune thrombocytopenia. Blood Res. 2015 Mar;50(1):19-25. doi: 10.5045/br.2015.50.1.19. Epub 2015 Mar 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Response	Platelet counts to >30×109/L on two consecutive occasions	28 days	No
Secondary	Complete Response	Platelet counts to >100×109/L on two consecutive occasions	28 days	No