Rituximab, Eltrombopag and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

NCT02834286 | Unknown Phase 2

• 1 other identifier: HE14-021
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Clinical Response

  Platelet counts to \>30×109/L on two consecutive occasions

  28 days

Secondary Outcomes (1)

• Complete Response

  28 days

Study Arms (1)

Rituximab, eltrombopag and dexamethasone

EXPERIMENTAL

Each patient will receive Rituximab 100 mg weekly days 1, 7, 14, 21 Eltrombopag 50 mg PO days 1-28 Dexamethasone 40 mg IV/PO days 1-4

Drug: Rituximab; Drug: Eltrombopag; Drug: Dexamethasone

Interventions

Rituximab DRUG

Rituximab 100 mg weekly days 1, 7, 14, 21

Rituximab, eltrombopag and dexamethasone

Eltrombopag DRUG

Eltrombopag 50 mg PO days 1-28

Rituximab, eltrombopag and dexamethasone

Dexamethasone DRUG

Dexamethasone 40 mg IV/PO days 1-4

Rituximab, eltrombopag and dexamethasone

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Servicio de Hematología, Hospital Universitario "Dr. José Eleuterio González", Universidad Autónoma de Nuevo León

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Related Publications (4)

• Gonzalez-Lopez TJ, Alvarez-Roman MT, Pascual C, Sanchez-Gonzalez B, Fernandez-Fuentes F, Jarque I, Perez-Rus G, Perez-Crespo S, Bernat S, Hernandez-Rivas JA, Andrade MM, Cortes M, Gomez-Nunez M, Olivera P, Martinez-Robles V, Fernandez-Rodriguez A, Fuertes-Palacio MA, Fernandez-Minano C, de Cabo E, Fisac R, Aguilar C, Barez A, Penarrubia MJ, Garcia-Frade LJ, Gonzalez-Porras JR. Eltrombopag safety and efficacy for primary chronic immune thrombocytopenia in clinical practice. Eur J Haematol. 2016 Sep;97(3):297-302. doi: 10.1111/ejh.12725. Epub 2016 Jan 27.

  PMID: 26709028 RESULT

• 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.

  PMID: 25830126 RESULT

• Gomez-Almaguer D, Herrera-Rojas MA, Jaime-Perez JC, Gomez-De Leon A, Cantu-Rodriguez OG, Gutierrez-Aguirre CH, Tarin-Arzaga L, Hernandez-Reyes J, Ruiz-Arguelles GJ. Eltrombopag and high-dose dexamethasone as frontline treatment of newly diagnosed immune thrombocytopenia in adults. Blood. 2014 Jun 19;123(25):3906-8. doi: 10.1182/blood-2014-01-549360. Epub 2014 May 6.

  PMID: 24802773 RESULT

• Gomez-Almaguer D, Tarin-Arzaga L, Moreno-Jaime B, Jaime-Perez JC, Ceballos-Lopez AA, Ruiz-Arguelles GJ, Ruiz-Delgado GJ, Cantu-Rodriguez OG, Gutierrez-Aguirre CH, Sanchez-Cardenas M. High response rate to low-dose rituximab plus high-dose dexamethasone as frontline therapy in adult patients with primary immune thrombocytopenia. Eur J Haematol. 2013 Jun;90(6):494-500. doi: 10.1111/ejh.12102. Epub 2013 Apr 2.

  PMID: 23470153 RESULT

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Rituximab; eltrombopag; Dexamethasone

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

David Gómez, MD

CONTACT

+5583486136; dgomezalmaguer@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hematology division chief

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: July 15, 2016
• Study Start: March 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: September 1, 2017
• Last Updated: July 15, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

ME (1)