Romiplostim, Rituximab and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Rituximab, Eltrombopag and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

NCT02834286

Immune Thrombocytopenia

UNKNOWN PHASE2

Romiplostim N01 Combined With Glucocorticoids as the First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Multicenter, Interventional Trial

NCT06992128

Primary Immune Thrombocytopenia (ITP)

RECRUITING PHASE2

Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia

NCT05325593

Primary Immune Thrombocytopenia

ACTIVE_NOT_RECRUITING PHASE3

Low-dose Rituximab and High-dose Dexamethasone as First Line Treatment for ITP

NCT01107951

Immune Thrombocytopenic Purpura

COMPLETED PHASE2

A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP

NCT06658834

Primary Immune Thrombocytopenia

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Immune Thrombocytopenia Thrombotic Thrombocytopenic Purpura

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Romiplostim

Intervention Type DRUG

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

Rituximab

Intervention Type DRUG

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

Dexamethasone

Intervention Type DRUG

40 mg IV/PO days 1-4

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Romiplostim

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

Intervention Type DRUG

Rituximab

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

Intervention Type DRUG

Dexamethasone

40 mg IV/PO days 1-4

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No