Romiplostim, Rituximab and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

NCT04588194 | Unknown Phase 2 DMC

• 1 other identifier: Hospital Universitario
• Study Type: interventional
• Target: 12
• 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, romiplostim and high-dose dexamethasone.

Conditions

Immune Thrombocytopenia; Thrombotic Thrombocytopenic Purpura

Keywords

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)

Romiplostim, Rituximab, Dexamethasone

EXPERIMENTAL

Each patient will receive Rituximab 100 mg weekly days 1, 7, 14, 21, Romiplostim 2mcg/Kg subcutaneously weekly days 1, 7, 14, 21 and Dexamethasone 40 mg IV/PO days 1-4.

Drug: Romiplostim; Drug: Rituximab; Drug: Dexamethasone

Interventions

Romiplostim DRUG

Romiplostim 2mcg/Kg subcutaneously weekly days 1, 7, 14, 21

Romiplostim, Rituximab, Dexamethasone

Rituximab DRUG

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

Romiplostim, Rituximab, Dexamethasone

Dexamethasone DRUG

40 mg IV/PO days 1-4

Romiplostim, Rituximab, 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 thrombocytopenia (IT) Platelet count less than 30,000/mm3 on two occasions.
• Subject ≥ 16 years
• Subject has signed and dated written informed consent.

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
• Active infection, sepsis or fever
• Positive for hepatitis B virus or hepatitis C virus or human immunodeficiency virus.

Sponsors & Collaborators

• David Gomez Almaguer: 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)

• 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

• 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.

  PMID: 23616916 RESULT

• 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.

  PMID: 27307776 RESULT

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Purpura, Thrombotic Thrombocytopenic; Thrombocytopenia

Interventions

romiplostim; Rituximab; Dexamethasone

Condition Hierarchy (Ancestors)

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

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

Study Officials

• David Gómez, MD

  Hospital Universitario J. Eleuterio González

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Gómez, MD

CONTACT

83486136; dgomezalmaguer@gmail.com

Mónica Bustillos, MD

CONTACT

6142255724; moni.bm88@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: SPONSOR INVESTIGATOR
• PI Title: David Gómez Almaguer

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: October 19, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2022
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)