#1 Clinical Trials Search in Europe

Study on the Safety and Effectiveness of Belantamab Mafodotin for Adults with Primary Immune Thrombocytopenia Previously Treated with Standard Medications

2 1 1

What is this study about?

This clinical trial is focused on studying a condition known as Primary Immune Thrombocytopenia (ITP). ITP is a disorder where the immune system mistakenly attacks and destroys platelets, which are cells that help blood clot. This can lead to easy or excessive bruising and bleeding. The trial will investigate a new treatment called belantamab mafodotin, which is being tested for its safety and effectiveness in treating adults with ITP who have previously been treated with standard medications like corticosteroids, thrombopoietin receptor agonists, and/or rituximab.

The purpose of the study is to evaluate how well belantamab mafodotin works in treating ITP. Participants in the trial will receive the medication in the form of a powder that is mixed into a solution and given through an injection into a vein. The study will monitor participants over a period of time to see how their condition responds to the treatment. Some participants may receive a placebo instead of the actual medication to help compare the effects.

Throughout the study, researchers will keep track of how participants respond to the treatment, including any changes in their platelet counts and any side effects they may experience. The trial aims to provide valuable information on whether belantamab mafodotin can be a safe and effective treatment option for people with Primary Immune Thrombocytopenia.

1 initial assessment

Upon joining the trial, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history, current health status, and previous treatments for primary immune thrombocytopenia.

A blood test is performed to check platelet levels and other relevant health indicators.

2 treatment initiation

The treatment involves the administration of belantamab mafodotin, a medication provided as a powder for solution for injection.

The medication is administered through intravenous use, meaning it is injected directly into a vein.

3 treatment schedule

The treatment is scheduled to continue for a period of up to 12 months, with regular monitoring to assess the response to the medication.

The frequency and dosage of the medication are determined by the healthcare provider based on individual response and tolerance.

4 monitoring and follow-up

Regular follow-up visits are scheduled to monitor the effectiveness of the treatment and any potential side effects.

These visits include physical examinations, blood tests, and assessments of any changes in symptoms.

5 response evaluation

The primary goal is to evaluate the complete response rate and partial response rate at 6 months of treatment.

Secondary evaluations include overall response rates at 2, 6, and 12 months, as well as monitoring for any adverse events.

6 completion of trial

Upon completion of the trial period, a final assessment is conducted to determine the overall effectiveness and safety of the treatment.

Participants are provided with a summary of their treatment outcomes and any necessary follow-up care is arranged.

Who Can Join the Study?

  • Participants must be 18 years or older.
  • Must have Primary Immune Thrombocytopenia (ITP) with a platelet cell count of less than 30 billion per liter. Platelets are tiny blood cells that help your body form clots to stop bleeding.
  • Must have had first-line therapy with corticosteroids. These are medicines that help reduce inflammation and suppress the immune system.
  • Must have had second-line therapy with TPO-RA (medicines that help increase platelet production) and/or rituximab (a medicine that targets certain immune cells) and did not achieve or maintain a response.
  • Must have adequate organ function as shown by specific lab tests:
    • Hematologic:
      • Absolute neutrophil count of at least 1.5 billion per liter. Neutrophils are a type of white blood cell important for fighting infections.
      • Hemoglobin of at least 8.0 grams per deciliter. Hemoglobin is a protein in red blood cells that carries oxygen.
    • Hepatic (liver function):
      • Total bilirubin of 1.5 times the upper limit of normal or less. Bilirubin is a substance made during the normal breakdown of red blood cells.
      • Alanine aminotransferase of 2.5 times the upper limit of normal or less. This is an enzyme found in the liver.
    • Renal (kidney function):
      • Estimated glomerular filtration rate of at least 30 milliliters per minute per 1.73 square meters. This measures how well the kidneys are filtering blood.
  • Female participants must use contraception according to local regulations and must not be pregnant or breastfeeding. They must meet one of the following:
    • Not be a woman of childbearing potential. This means:
      • 45 years or older and no menstrual period for over a year.
      • If less than 2 years without periods and no history of certain surgeries, must have a specific hormone level in the postmenopausal range.
      • Have had surgeries like hysterectomy (removal of the uterus) or oophorectomy (removal of the ovaries).
    • If a woman of childbearing potential, must use a highly effective contraceptive method and have a negative pregnancy test before starting the trial.
  • Male participants must use contraception according to local regulations and agree to:
    • Not donate sperm.
    • Be abstinent from heterosexual intercourse or use a condom and ensure their female partner uses an additional highly effective contraceptive method.
  • Must have an Eastern Cooperative Oncology Group Performance Status of 2 or less. This is a scale that measures how well a person can perform daily activities.
  • Must be able to understand the trial procedures and agree to participate by providing written informed consent.

Who Cannot Join the Study?

  • Patients who have a different condition than Primary Immune Thrombocytopenia cannot participate. This condition is a disorder where the immune system attacks and destroys platelets, which are cells that help blood clot.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
  • Patients who are not part of the specified clinical trial groups cannot participate. These groups are usually defined by the study based on certain characteristics.
  • Patients who are not willing to follow the study procedures and requirements cannot participate.
  • Patients who have other medical conditions that might interfere with the study treatment cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate, as the effects on the baby are not known.
  • Patients who have participated in another clinical trial recently may not be eligible to participate.
  • Patients who have allergies or reactions to the study medication or similar medications cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Alexandra Hospital Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Greece Greece
Recruiting
16.12.2024

Trial locations

Investigated drugs:

Belantamab Mafodotin is a medication being studied for its potential to treat adult patients with primary immune thrombocytopenia. This condition involves a low platelet count, which can lead to easy bruising and bleeding. The trial is investigating how effective and safe this medication is for patients who have already been treated with other therapies like thrombopoietin receptor agonists or rituximab, following initial treatment with corticosteroids. Belantamab mafodotin works by targeting specific cells in the body to help increase platelet counts and improve symptoms.

Primary Immune Thrombocytopenia – This is a disorder where the immune system mistakenly attacks and destroys platelets, which are cells in the blood that help with clotting. As a result, individuals with this condition often experience easy or excessive bruising and bleeding. The disease can develop suddenly or gradually, and its severity can vary from mild to severe. In some cases, it may resolve on its own, while in others, it can persist for a longer period. The exact cause of the immune system’s attack on platelets is not well understood. It is considered a rare disease, affecting a small percentage of the population.

Trial ID:
2023-509131-12-01
Protocol code:
EAE140
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A Study to Test How Safe Budoprutug Is and How Well It Works in Patients with Immune Thrombocytopenia

    Recruiting

    1 1 1
    Investigated drugs:
    Bulgaria Greece Spain

  • A Follow-up Study of Mezagitamab in Adults with Chronic Primary Immune Thrombocytopenia to Evaluate Long-term Safety and Effectiveness

    Recruiting

    3 1 1
    Bulgaria Croatia Czechia France Germany Greece +6