Romiplostim, Rituximab and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

Immune Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04588194
• Other study ID #: Hospital Universitario
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: October 2020
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: David Gómez, MD
• Phone: 83486136
• Email: dgomezalmaguer[@]gmail.com
• Is FDA regulated: No
• 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, romiplostim 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. Romiplostim, 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 romiplostim 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), romiplostim (2mcg/Kg four weekly) 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: 12
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Purpura, Thrombotic Thrombocytopenic
• Thrombocytopenia
• Thrombotic Thrombocytopenic Purpura

Intervention

Drug:
• Romiplostim
Romiplostim 2mcg/Kg subcutaneously weekly days 1, 7, 14, 21
• Rituximab
Rituximab 100 mg weekly days 1, 7, 14, 21
• 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
David Gomez Almaguer

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

Cooper N, Terrinoni I, Newland A. The efficacy and safety of romiplostim in adult patients with chronic immune thrombocytopenia. Ther Adv Hematol. 2012 Oct;3(5):291-8. doi: 10.1177/2040620712453596. — View Citation

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

Vishnu P, Aboulafia DM. Long-term safety and efficacy of romiplostim for treatment of immune thrombocytopenia. J Blood Med. 2016 May 25;7:99-106. doi: 10.2147/JBM.S80646. eCollection 2016. Review. — 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
Secondary	Complete Response	Platelet counts to >100×109/L on two consecutive occasions	28 days