Romiplostim, Rituximab and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia
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|ClinicalTrials.gov Identifier: NCT04588194|
Recruitment Status : Unknown
Verified October 2020 by David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez.
Recruitment status was: Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Immune Thrombocytopenia Thrombotic Thrombocytopenic Purpura||Drug: Romiplostim Drug: Rituximab Drug: Dexamethasone||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
Romiplostim 2mcg/Kg subcutaneously weekly days 1, 7, 14, 21
Rituximab 100 mg weekly days 1, 7, 14, 21
40 mg IV/PO days 1-4
- Clinical Response [ Time Frame: 28 days ]Platelet counts to >30×109/L on two consecutive occasions
- 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|
- 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.
- 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
- Active infection, sepsis or fever
- Positive for hepatitis B virus or hepatitis C virus or human immunodeficiency virus.
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
|Contact: David Gómez, MDemail@example.com|
|Contact: Mónica Bustillos, MDfirstname.lastname@example.org|
|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 email@example.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|
|Principal Investigator:||David Gómez, MD||Hospital Universitario J. Eleuterio González|
|Responsible Party:||David Gomez Almaguer, David Gómez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez|
|Other Study ID Numbers:||
|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|
|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|
Purpura, Thrombocytopenic, Idiopathic
Purpura, Thrombotic Thrombocytopenic
Blood Platelet Disorders
Blood Coagulation Disorders
Immune System Diseases
Antineoplastic Agents, Immunological
Physiological Effects of Drugs
Peripheral Nervous System Agents