Epcoritamab test in combination with lenalidomide and rituximab for adult lymphoma patients

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    What is this study about?

    This study assesses the safety and performance of the drug epcoritamab, combined with lenalidomide and rituximab, in adults with Follicular Lymphoma, a frequently occurring B-cell cancer which often recurs despite current treatments. The test aims to monitor adverse side effects and changes in the disease’s activity in patients whose illness has relapsed or not responded to previous treatments. Approximately 500 adults around the world will receive the treatment as part of this study. They will be assigned to one of three treatment groups. Some may undergo heavier treatment than their current care standards. Their response to treatment will be regularly monitored through medical assessments, blood tests, side effects tracking, and questionnaires.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Sankt Poelten , Austria

      Linz , Austria

      Salzburg , Austria

      Edegem , Belgium

      La Louviu00e8re , Belgium

      Sint-Niklaas , Belgium

      Leuven , Belgium

      Liege , Belgium

      Turnhout , Belgium

      Hradec Kralove , Czechia

      Praha , Czechia

      Praha , Czechia

      Praha , Czechia

      Herning , Denmark

      Vejle , Denmark

      Clermont , France

      Rennes , France

      Dijon , France

      Limoges CEDEX 1 , France

      Nimes CEDEX 9 , France

      Pessac , France

      Reims CEDEX , France

      Vandoeuvre-les-Nancy , France

      Lille , France

      Nantes , France

      Lyon CEDEX 08 , France

      Pierre Benite CEDEX , France

      Poitiers , France

      Caen , France

      Cru00e9teil , France

      La Roche Sur Yon , France

      Paris , France

      Paris , France

      Toulouse Cedex 9 , France

      Leipzig , Germany

      Jena , Germany

      Bamberg , Germany

      Berlin , Germany

      Bonn , Germany

      Dresden , Germany

      Essen , Germany

      Kassel , Germany

      Magdeburg , Germany

      Trier , Germany

      Wuerzburg , Germany

      Athens , Greece

      Athens , Greece

      Athens , Greece

      Athens , Greece

      Ioannina , Greece

      Thessaloniki , Greece

      Thessaloniki , Greece

      Szeged , Hungary

      Debrecen , Hungary

      Kaposvu00e1r , Hungary

      Nyiregyhaza , Hungary

      Szombathely , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Rome , Italy

      Milan , Italy

      Milan , Italy

      Torino , Italy

      Candiolo , Italy

      Alessandria , Italy

      Brescia , Italy

      Napoli , Italy

      Novara , Italy

      Palermo , Italy

      Ravenna , Italy

      Hoorn Nh , Netherlands

      Dordrecht , Netherlands

      Rotterdam , Netherlands

      Amsterdam , Netherlands

      Breda , Netherlands

      Deventer , Netherlands

      Enschede , Netherlands

      Goes , Netherlands

      Groningen , Netherlands

      Leiden , Netherlands

      Nieuwegein , Netherlands

      Krakow , Poland

      Gdynia , Poland

      Kielce , Poland

      Skorzewo , Poland

      Badalona , Spain

      Hospitalet de Llobregat , Spain

      Santander , Spain

      Pamplona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Caceres , Spain

      Cordoba , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Salamanca , Spain

      Sevilla , Spain

      Lulea , Sweden

      Boras , Sweden

      Linkoping , Sweden

      Oxford , United Kingdom

      Leeds , United Kingdom

      Plymouth , United Kingdom


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      Patients participating in this clinical trial will need to take several steps depending on the arm of the study they are assigned to. Generally, the steps include:

      1. Receiving epcoritamab (the dosage will be either Dose A or Dose B, as determined by the trial protocol).
      2. Receiving lenalidomide in combination with rituximab (referred to as R2).
      3. These treatments are administered for 12 cycles, where each cycle is 28 days long.

      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To be eligible to join the study based on disease criteria, you need to have:

      1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
      2. Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan showing a positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI) defined anatomical tumor sites.
      3. At least one measurable nodal lesion (longer than 1.5 cm) or at least one measurable extra-nodal lesion (longer than 1.0 cm) on CT scan or MRI.
      4. Histologically confirmed classic follicular lymphoma (FL) previously Grade 1 to 3a FL, stage II, III, or IV, with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on the most recent representative tumor biopsy based on the pathology report.

      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria:

      • Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.
        – This is a scale that measures how cancer affects the daily living abilities of a patient. A score of 0 indicates fully active and able to carry on all pre-disease activities without restriction, 1 indicates restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, and 2 indicates ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours.
      • Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND
        – FDG-PET is a type of medical imaging that helps to show the metabolic activity and the presence of cancer. A positive lesion indicates an area with high metabolic activity that could signify cancer, and this must be consistent with findings on a CT or MRI scan.
      • At least 1 measurable nodal lesion (long axis > 1.5 cm) or at least 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI.
        – Measurable lesions are those tumors that can be accurately measured in size with imaging equipment. Nodal lesions are related to lymph nodes, whereas extra-nodal lesions are found in other parts of the body.
      • Histologically confirmed classic follicular lymphoma (FL) [previously Grade 1 to 3a FL] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy based on the pathology report.
        – Histologically confirmed means that the diagnosis has been made by examining cells under a microscope. Follicular lymphoma is a type of blood cancer that affects lymphocytes (a type of white blood cell) and is graded based on how the cells look under the microscope. CD20+ means that the cancer cells have a protein called CD20 on their surface. Stages II, III, and IV indicate the spread of cancer, with higher numbers often indicating more widespread disease.
      • Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy.
        – Relapsed means the cancer has returned after treatment. Refractory means the cancer does not respond to treatment. Systemic regimens are treatments that affect the entire body, and anti-CD20 mAb is a type of therapy that targets the CD20 protein on the surface of cancer cells.
      • Eligible to receive R2 per investigator determination.
        – R2 refers to a combination of the drugs rituximab and lenalidomide, which is used to treat certain types of lymphoma. The investigator’s determination means that the trial’s doctor has evaluated and approved you for this therapy.

      The study also has exclusion criteria, but as per your request, these are not included in the list.

      What Reasons Could Exclude Me from the Study?

      Exclusion Criteria:

      • Documented refractoriness to lenalidomide: This means that a patient has been treated with lenalidomide previously and the disease did not respond to this treatment, or the condition got worse despite this treatment.
      • Lenalidomide exposure within 12 months prior to randomization: This indicates that the patient has received lenalidomide within the year before being potentially assigned to a treatment arm in the clinical trial.

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are:

      1. Epcoritamab (also known as GEN3013) – This is a subcutaneous injection intended for use in combination with other drugs. Epcoritamab is a bispecific antibody designed to target both CD3 on T-cells and CD20 on B-cells, which makes it a potential treatment for certain types of non-Hodgkin’s lymphoma, where it can redirect T-cells to induce killing of the malignant B-cells.
      2. Rituximab – This is an intravenous infusion, which is a chimeric monoclonal antibody targeting the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab is used to treat diseases characterized by excessive, uncontrolled growth of B cells, such as non-Hodgkin’s lymphoma and chronic lymphocytic leukemia, as well as certain autoimmune disorders.
      3. Lenalidomide – This is administered as oral capsules. Lenalidomide is an immunomodulatory drug that affects the immune system and can also interfere with the environment that supports tumor growth. It is commonly used in the treatment of multiple myeloma and certain myelodysplastic syndromes.

      These are the primary active substances and their brief descriptions. Each of these drugs works through different mechanisms of action to treat cancer or modulate the immune response.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The clinical trial is investigating the following active substances:

      1. Rituximab: A well-known medication commonly used for the treatment of certain autoimmune diseases and types of cancer, including non-Hodgkin lymphoma and chronic lymphocytic leukemia.
      2. Lenalidomide: An immunomodulating drug that is used to treat various cancers, such as multiple myeloma and mantle cell lymphoma.
      3. Epcoritamab: An investigational drug being developed specifically for the treatment of follicular lymphoma (FL). It is not yet widely known within medicine or medical literature as it is currently being tested for safety and effectiveness.

      Participants in the clinical trial receive rituximab and lenalidomide as part of the regimen, with some receiving additional treatment with epcoritamab to evaluate its potential benefits and risks.


      Study ID

      CT-EU-00021156

      Recruitment status

      Recruting new patients

      Start of the trial

      2 years ago

      Study phase

      Phase
      III