Study on new combination therapy for aggressive lymphoma

Recruting new patients

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    What is this study about?

    This study is about a less common but severe form of cancer known as Diffuse Large B-Cell Lymphoma (DLBCL). It is testing if a new medication called epcoritamab, given with a mix of other commonly used cancer medicines, can help control the disease better. These other medicines include rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone, which are often collectively referred to as R-CHOP. The study includes about 900 adults from around the world who have recently been diagnosed with this type of lymphoma. They will be split into two groups. One group will get epcoritamab with R-CHOP and then continue with epcoritamab. The other group will get R-CHOP followed by rituximab. Doctors will carefully watch for changes in the disease and for any side effects. There will be many checks on health, including medical exams, blood tests, questionnaires, and monitoring of any side effects.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Sankt Poelten , Austria

      Vienna , Austria

      Vienna , Austria

      Salzburg , Austria

      La Louviu00e8re , Belgium

      Liu00e8ge , Belgium

      Godinne , Belgium

      Gent , Belgium

      Sint-Niklaas , Belgium

      Leuven , Belgium

      Roeselare , Belgium

      Anderlecht , Belgium

      Plovdiv , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Brno , Czechia

      Hradec Kralove , Czechia

      Ostrava , Czechia

      Praha , Czechia

      Praha , Czechia

      Praha , Czechia

      Copenhagen u00d8 , Denmark

      Aarhus N , Denmark

      Roskilde , Denmark

      Odense C , Denmark

      Vejle , Denmark

      Nice , France

      Marseille , France

      Rennes , France

      Dijon , France

      Limoges CEDEX 1 , France

      Montpellier Cedex 5 , France

      Lille , France

      Nantes , France

      Bayonne , France

      Pierre Benite CEDEX , France

      Amiens CEDEX 1 , France

      Angers , France

      Caen , France

      Cru00e9teil , France

      La Roche Sur Yon , France

      La Tronche , France

      Paris , France

      Rouen , France

      Saint-cloud , France

      Athens , Greece

      Athens , Greece

      Athens , Greece

      Athens , Greece

      Ioannina , Greece

      Thessaloniki , Greece

      Thessaloniki , Greece

      Szeged , Hungary

      Debrecen , Hungary

      Kaposvu00e1r , Hungary

      Szombathely , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Szekszard , Hungary

      San Giovanni Rotondo , Italy

      Milan , Italy

      Milan , Italy

      Candiolo , Italy

      Alessandria , Italy

      Brescia , Italy

      Meldola , Italy

      Napoli , Italy

      Novara , Italy

      Palermo , Italy

      Ravenna , Italy

      Almere , Netherlands

      Apeldoorn , Netherlands

      Hilversum , Netherlands

      Hoorn Nh , Netherlands

      Zaandam , Netherlands

      Dordrecht , Netherlands

      Alkmaar , Netherlands

      Amersfoort , Netherlands

      Amsterdam , Netherlands

      Amsterdam , Netherlands

      Breda , Netherlands

      Den Haag , Netherlands

      Deventer , Netherlands

      Eindhoven , Netherlands

      Eindhoven , Netherlands

      Enschede , Netherlands

      Groningen , Netherlands

      Haarlem , Netherlands

      Leeuwarden , Netherlands

      Leiden , Netherlands

      Maastricht , Netherlands

      Nieuwegein , Netherlands

      Nijmegen , Netherlands

      S Hertogenbosch , Netherlands

      Tilburg , Netherlands

      Utrecht , Netherlands

      Slupsk , Poland

      Kielce , Poland

      Olsztyn , Poland

      Pila , Poland

      Skorzewo , Poland

      Braga , Portugal

      Lisboa , Portugal

      Lisboa , Portugal

      Porto , Portugal

      Badalona , Spain

      Hospitalet de Llobregat , Spain

      Pamplona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Cordoba , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Valencia , Spain

      Boras , Sweden

      Gothenburg , Sweden

      Linkoping , Sweden

      Solna , Sweden


      Study Steps

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

      The steps a patient needs to take in this clinical trial include:

      1. Receiving subcutaneous epcoritamab.
      2. Receiving a combination of intravenous and oral medications, including rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (known collectively as R-CHOP).
      3. This treatment is followed by epcoritamab, all of which are administered in 21-day cycles.

      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you must have one of the following newly diagnosed, histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL) based on the WHO 2016 classification:

      1. DLBCL, Not Otherwise Specified (NOS).
      2. High-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology.
      3. T-cell/histiocyte-rich large B-cell lymphoma.
      4. Epstein-Barr virus-positive DLBCL, NOS.
      5. Follicular lymphoma Grade 3b.

      These are the specific diseases you need to have in order to be eligible for the study.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Below is a list of the conditions that you must meet to join the study, along with explanations of the medical terms:

      1. Planned Treatment with R-CHOP: You are planned to receive treatment with 6 cycles of standard R-CHOP, which is a combination chemotherapy regimen that includes rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone.
      2. Newly Diagnosed CD20+ DLBCL: You must have a newly diagnosed, histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL), which is a type of non-Hodgkin lymphoma. This can be ‘de novo’ DLBCL or transformed from follicular lymphoma, based on a recent tumor biopsy. The specific subtypes of DLBCL allowed are detailed in the criteria.
      3. Availability of Tumor Tissue: Archival or freshly collected tumor tissue must be available for review at screening. If archival tissue is used, it must have been obtained within 8 weeks prior to the first cycle of the planned treatment.
      4. IPI Score of 2-5: The International Prognostic Index (IPI) score must be between 2 and 5. This score predicts the prognosis of DLBCL patients based on age, stage of cancer, serum lactate dehydrogenase (LDH) level, performance status, and number of extranodal sites.
      5. ECOG Performance Status Score of 0-2: Before initiating R-CHOP treatment, your performance status, as measured by the Eastern Cooperative Oncology Group (ECOG) scale, must be between 0 (fully active) and 2 (ambulatory and capable of self-care but unable to carry out work activities). Those initially with a score greater than 3 may be screened if improvement is expected.
      6. Measurable Disease: You must have at least one target lesion that is measurable. This means that you should have a lymph node that is larger than 1.5 cm in its long axis, or an extranodal lesion (outside of the lymph nodes) that is larger than 1 cm, which can be evaluated using CT or MRI scans. Additionally, the lesion must be PET-positive on a PET-CT scan, indicating active cancer.
      7. Laboratory Values Within Protocol Criteria: Your laboratory test results must meet the specific criteria laid out in the study protocol.
      8. Left Ventricular Ejection Fraction ≥50%: Your heart’s left ventricular ejection fraction, which measures how well your heart is pumping blood, must be equal to or greater than 50%. This measurement can be determined by multi-gated acquisition (MUGA) scan or transthoracic echocardiography carried out during the screening process.

      These criteria are designed to ensure that the study includes participants who have a specific type of lymphoma and are in a physical condition that allows them to potentially benefit from the treatment being studied.

      What Reasons Could Exclude Me from the Study?

      Here is a list of conditions under which you cannot take part in the study, along with explanations of the medical terms:

      1. History of prior systemic anti-lymphoma therapy for diagnosed diffuse large b-cell lymphoma (DLBCL) including any definitive radiotherapy with curative intent: This means if you have previously received treatment for DLBCL, such as chemotherapy or radiotherapy intended to cure the illness, you are not eligible. ‘Systemic’ refers to treatment that affects the entire body, as opposed to local treatment that targets a specific area.
      2. Clinically significant cardiovascular disease: If you have heart conditions that a clinician considers important and could affect your safety or the outcomes of the trial, you will be excluded. ‘Clinically significant’ means that the disease has the potential to impact your health in a meaningful way during the course of the trial.

      These are examples of exclusion criteria that might prevent you from participating in the clinical trial according to the document we have reviewed.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The study involves the following drugs, with the active substances provided in brackets:

      1. Epcoritamab – A subcutaneous injection primarily being developed for the treatment of diffuse large B-cell lymphoma (DLBCL).
      2. Cyclophosphamide – An intravenous injection; an alkylating agent that works by slowing or stopping cell growth.
      3. Rituximab (Rituximab) – An intravenous infusion; a monoclonal antibody that can bind to certain types of B cells and can help reduce the number of abnormal B cells caused by DLBCL and other conditions.
      4. Vincristine (Vincristine sulfate) – An intravenous infusion; an anti-mitotic chemotherapy used to treat various types of cancer.
      5. Doxorubicin (Doxorubicin Hydrochloride) – An intravenous infusion; an anthracycline type of chemotherapy that is used to treat various types of cancer.
      6. Prednisone – An oral tablet; a corticosteroid that can be used to suppress the immune system and inflammation. It is also used in combination with other drugs for cancer treatment.

      Please note that these descriptions are brief and may not cover all the uses or actions of the drugs.

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

      The active substances participating in the clinical trial are well-known in medicine and medical literature. Here is a list of the substances along with descriptions for each:

      1. Prednisone: Known as a glucocorticoid, Prednisone is a steroid medication commonly used to suppress the immune system and to reduce inflammation. It is used for a range of conditions including autoimmune diseases and allergies.
      2. Cyclophosphamide: This is an alkylating agent used in chemotherapy. It works by interfering with the growth of cancer cells, which are then destroyed by the body. Cyclophosphamide is used to treat various types of cancer and some autoimmune disorders.
      3. Rituximab: An immunological antineoplastic agent, Rituximab is a monoclonal antibody that targets the CD20 protein found on the surface of B-cells. It 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 autoimmune diseases like rheumatoid arthritis.
      4. Doxorubicin: This is an antibiotic chemotherapeutic drug that interferes with DNA replication in cancer cells, inducing cell death. Doxorubicin is used to treat various cancers, including leukemia, lymphoma, and breast cancer.
      5. Vincristine: A member of the vinca alkaloid class of chemotherapy drugs, Vincristine works by inhibiting microtubule formation in the mitotic spindle, which is essential for cell division. Vincristine is used to treat several different types of cancers, such as leukemia and lymphoma.

      All of these substances are part of standard medical treatment protocols and are referenced extensively in medical research and literature.


      Study ID

      CT-EU-00057564

      Recruitment status

      Recruting new patients

      Start of the trial

      1 year ago