Romiplostim Rituximab and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

  • STATUS
    Recruiting
  • End date
    Nov 1, 2022
  • participants needed
    12
  • sponsor
    David Gomez Almaguer
Updated on 25 January 2021
platelet count
rituximab
thrombocytopenia
dexamethasone
romiplostim

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.

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 >150109/L on two consecutive occasions. A clinical response is defined as an increase in the platelet count between >30109/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 <30109/L) or to time of analysis Patients will be evaluated each week during 4 weeks and then every month for at least 6 months.

Details
Condition IDIOPATHIC THROMBOCYTOPENIC PURPURA, Idiopathic Thrombocytopenic Purpura (ITP), Thrombocytopenic, THROMBOTIC THROMBOCYTOPENIC PURPURA, Autoimmune disease, Autoimmune disease, Immune Thrombocytopenia, Idiopathic Thrombocytopenic Purpura (ITP), Thrombocytopenic, autoimmune thrombocytopenia
Treatment Rituximab, Dexamethasone, romiplostim
Clinical Study IdentifierNCT04588194
SponsorDavid Gomez Almaguer
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note