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Romiplostim, Rituximab and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

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ClinicalTrials.gov Identifier: NCT04588194
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez

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.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Thrombotic Thrombocytopenic Purpura Drug: Romiplostim Drug: Rituximab Drug: Dexamethasone Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Romiplostim in Combination With Low-dose Rituximab and High-dose Dexamethasone as Frontline Treatment for Immune Thrombocytopenia
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2022


Arm Intervention/treatment
Experimental: Romiplostim, Rituximab, Dexamethasone
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
Romiplostim 2mcg/Kg subcutaneously weekly days 1, 7, 14, 21

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

Drug: Dexamethasone
40 mg IV/PO days 1-4




Primary Outcome Measures :
  1. Clinical Response [ Time Frame: 28 days ]
    Platelet counts to >30×109/L on two consecutive occasions


Secondary Outcome Measures :
  1. Complete Response [ Time Frame: 28 days ]
    Platelet counts to >100×109/L on two consecutive occasions



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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04588194


Contacts
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Contact: David Gómez, MD 83486136 dgomezalmaguer@gmail.com
Contact: Mónica Bustillos, MD 6142255724 moni.bm88@gmail.com

Locations
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Mexico
Servicio de Hematología, Hospital Universitario "Dr. José Eleuterio González", Universidad Autónoma de Nuevo León Recruiting
Monterrey, Nuevo León, Mexico, 64460
Contact: Mónica Bustillos, MD    6142255724    moni.bm88@gmail.com   
Principal Investigator: David Gómez-Almaguer, MD         
Sub-Investigator: Perla R. Colunga-Pedraza, MD         
Sub-Investigator: Olga Cantú-Rodríguez, MD         
Sub-Investigator: César H. Gutiérrez-Aguirre, MD         
Sub-Investigator: Luz Tarín-Arzaga, MD         
Sub-Investigator: Mónica Bustillos, MD         
Sponsors and Collaborators
David Gomez Almaguer
Investigators
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Principal Investigator: David Gómez, MD Hospital Universitario J. Eleuterio González
Publications of Results:
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Responsible Party: David Gomez Almaguer, David Gómez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT04588194    
Other Study ID Numbers: Hospital Universitario
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez:
thrombocytopenia
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Purpura, Thrombotic Thrombocytopenic
Blood Platelet Disorders
Hematologic Diseases
Blood Coagulation Disorders
Hemorrhage
Pathologic Processes
Skin Manifestations
Thrombotic Microangiopathies
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Thrombophilia
Dexamethasone
Rituximab
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Immunological