Comparing treatments for new Large B-cell lymphoma patients

Recruting new patients

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    What is this study about?

    The trial aims to analyze and compare two drug treatments for people who have a large B-Cell Lymphoma, a kind of cancer that affects a certain type of white blood cells, and have not yet started their treatment. The first treatment is a combination of glofitamab, polatuzumab vedotin, and other common drugs used for this condition: rituximab, cyclophosphamide, doxorubicin, and prednisone. The second treatment is the same, but doesn’t include the glofitamab. The goal is to understand which treatment is more effective and safer for the patient.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Anderlecht , Belgium

      Brussel , Belgium

      Edegem , Belgium

      Gent , Belgium

      Kortrijk , Belgium

      Liu00e8ge , Belgium

      Aalborg , Denmark

      Aarhus N , Denmark

      Herning , Denmark

      Lille , France

      Lyon , France

      Marseille , France

      Montpellier , France

      Nantes , France

      Pessac , France

      Rennes , France

      Rouen , France

      Strasbourg , France

      Toulouse , France

      Brandenburg an der Havel , Germany

      Erlangen , Germany

      Hamburg , Germany

      Koeln , Germany

      Magdeburg , Germany

      Potsdam , Germany

      Ulm , Germany

      Wu00fcrzburg , Germany

      Modena , Italy

      Genova , Italy

      Bergamo , Italy

      Milano , Italy

      Rozzano , Italy

      Prato , Italy

      Vicenza , Italy

      Brzozu00f3w , Poland

      Kraku00f3w , Poland

      Santiago de Compostela , Spain

      Pozuelo de Alarcon , Spain

      Pamplona , Spain

      Barcelona , Spain

      Madrid , Spain

      Sevilla , Spain

      Valencia , Spain

      Canterbury , United Kingdom

      Glasgow , United Kingdom

      London , United Kingdom

      Newcastle , United Kingdom

      Nottingham , United Kingdom

      Oxford , United Kingdom


      Study Steps

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

      The steps that a patient needs to take in this clinical trial involve receiving a combination of different drugs. Participants will receive:

      1. Glofitamab (IV administration)
      2. Polatuzumab vedotin (IV administration)
      3. Rituximab (IV administration)
      4. Cyclophosphamide (part of CHP chemotherapy)
      5. Doxorubicin (IV administration)
      6. Prednisone (oral administration)

      This combination is known as Pola-R-CHP. Unfortunately, the exact durations and specific schedules for these medications were not explicitly detailed in the information available. If you require more detailed information about the treatment schedule, such as the dosage, frequency of administration, and period of treatment, please let me know so I can attempt to find this information for you.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have CD20-positive large B-cell lymphoma (LBCL) as this is an inclusion criterion. However, you must not have a history of certain types of lymphoma or currently have specific diagnoses, as these are part of the exclusion criteria. Specifically, you cannot participate in the study if you currently have or have a history of the following diseases:

      1. Follicular lymphoma grade 3B
      2. Transformations of indolent B-cell lymphomas (e.g., de novo transformed follicular lymphoma)
      3. Mediastinal grey zone lymphoma
      4. Primary mediastinal (thymic) large B-cell lymphoma
      5. Burkitt lymphoma
      6. Primary large B-cell lymphoma of immune-privileged sites (including primary diffuse large B-cell lymphoma of the CNS, primary large B-cell lymphoma of the vitreoretina, and primary large B-cell lymphoma of the testis)
      7. Primary effusion DLBCL
      8. Primary cutaneous DLBCL, leg type

      These are the specific disease-related exclusion criteria for the study.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Here are the Inclusion Criteria for the study along with explanations of the medical terms where applicable:

      1. Previously untreated participants with CD20-positive LBCL: The study is open to participants who have not received any prior treatment for large B-cell lymphoma (LBCL) that is positive for a protein called CD20 on the surface of the cancer cells.
      2. Ability to provide tumor tissue: Participants must be able to supply a tissue sample of their tumor for study purposes.
      3. International prognostic index (IPI) score 2-5: The IPI is a clinical tool used to predict the prognosis of patients with non-Hodgkin’s lymphoma based on five factors: age, stage of cancer, serum lactate dehydrogenase (LDH) level, performance status, and number of extranodal sites. Scores range from 0 to 5, with higher scores indicating a poorer prognosis.
      4. Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2: The ECOG performance status is a scale used to assess how a patient’s disease affects their daily living abilities. Scores range from 0 to 5 with:
        • 0 – Fully active, able to carry on all pre-disease activities without restriction.
        • 1 – Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.
        • 2 – Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.
      5. At least one bi-dimensionally measurable lesion, defined as > 1.5 cm in its longest dimension as measured by CT or MRI: Participants must have at least one detectable and measurable tumor lesion, where ‘measurable’ is defined by having a size of more than 1.5 centimeters in its largest dimension, as shown by a CT scan or MRI.
      6. Left ventricular ejection fraction (LVEF) >/=50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO): The left ventricular ejection fraction is a measurement of how much blood the left ventricle of the heart pumps out with each contraction, and must be 50% or greater. This needs to be demonstrated with a MUGA scan or an ECHO, which are both types of cardiac imaging tests.
      7. Adequate hematologic function: Participants must have a sufficient level of blood cell counts, indicating that the bone marrow is functioning well enough to produce red blood cells, white blood cells, and platelets.
      8. Negative HIV test at screening with exceptions as defined by the protocol: Participants must have a negative test for the Human Immunodeficiency Virus (HIV) unless there are specific exceptions outlined by the study protocol.
      9. Negative SARS-CoV-2 antigen or PCR test: Participants must have a negative test for the coronavirus (SARS-CoV-2), which has to be either an antigen test or a PCR (Polymerase Chain Reaction) test.

      Please note that you must meet all of these inclusion criteria to participate in the study.

      What Reasons Could Exclude Me from the Study?

      Based on the exclusion criteria provided in the study document, here is a list where each condition is followed by a simple explanation of the associated medical terms:

      Exclusion Criteria:

      1. Contraindication to any components of Pola-R-CHP or glofitamab: You should not have any known allergies, sensitivities, or severe reactions to the drugs used in the study.
      2. Prior solid organ transplantation: You cannot participate if you’ve had an organ transplant.
      3. Peripheral neuropathy > Grade 1: A condition with nerve damage that causes tingling, numbness, and pain in your hands and feet.
      4. History of indolent lymphoma: If you’ve had a slow-growing type of lymphoma before, you’re not eligible.
      5. Prior treatment with systemic immunotherapeutic agents or monoclonal antibodies for cancer: Recent treatment with these therapies excludes you from the study.
      6. Previous cancer treatments: Apart from corticosteroids, you cannot have had any other treatments for large B-cell lymphoma.
      7. History of cancer affecting compliance or interpretation: Other cancers in your medical history that could interfere with the study’s protocol.
      8. Cardiovascular disease: You cannot have significant heart-related conditions.
      9. Major surgery recently: You may not be eligible if you’ve had significant surgery within four weeks before starting the study.
      10. Central nervous system disease: Conditions like a stroke, epilepsy, inflammation of brain blood vessels, or degenerative diseases.
      11. Treatment-emergent immune-related adverse events: Previous immune therapy complications make you ineligible.
      12. Active autoimmune disease: If you have an autoimmune disease that isn’t well-managed, you can’t join the study.
      13. Clinically significant liver disease: Serious liver conditions preclude study participation.
      14. Live vaccines recently or during the study: Having a live vaccine close to or during the study is not allowed.
      15. Active infection: If you have an infection that could affect safety in the study.
      16. Suspected or confirmed tuberculosis: Active or inactive tuberculosis makes you ineligible.
      17. Positive for chronic hepatitis B, hepatitis C, or HTLV-1: These viruses in your system mean you cannot participate.
      18. Progressive multifocal leukoencephalopathy: A rare and serious brain infection.

      The terms provided are simplified for better understanding. If you have any of these conditions, you would not be eligible to participate in the study.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are as follows:

      1. Glofitamab – This is an experimental monoclonal antibody designed for cancer immunotherapy. It has been specifically engineered to bind to CD20 on the surface of B-cells and CD3 on T-cells, bringing them into close proximity and leading to the activation and proliferation of T-cells. The T-cells then engage in killing the B-cell lymphoma cells.
      2. Polatuzumab Vedotin – It is an antibody-drug conjugate consisting of a monoclonal antibody targeting CD79b, a protein expressed by B-cells, linked to a potent chemotherapy drug. It works by selectively delivering the chemotherapy drug to B-cells, resulting in their destruction.
      3. Rituximab – This is a chimeric monoclonal antibody that targets CD20, a protein widely expressed on B-cells. Rituximab binds to CD20 and induces cell death through various mechanisms including complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity.
      4. Cyclophosphamide – As an antineoplastic agent, cyclophosphamide works by interfering with the growth of cancer cells, which are eventually destroyed. It is also an immunosuppressive agent used in many chemotherapy regimens.
      5. Doxorubicin – This cytotoxic chemotherapeutic agent works by intercalating DNA strands which inhibits the synthesis of nucleic acids and leads to apoptosis (cell death). It is used in the treatment of a variety of cancers.
      6. Prednisone – This is a glucocorticoid which not only serves to suppress the immune system but also possesses strong anti-inflammatory effects. Its role in the treatment of lymphomas is to help reduce inflammation and work in conjunction with other chemotherapy agents.

      These drugs are used in different combinations to evaluate the efficacy and safety of Glofitamab in combination with Polatuzumab Vedotin plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) versus Pola-R-CHP alone in patients with previously untreated large B-cell lymphoma.

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

      The document provided contains information about the active substances being investigated in the clinical trial. However, there was a technical issue that prevented the exact quotation of the relevant section. Nevertheless, I can still provide you with a list of the active substances mentioned in the document and their known status in medical literature:

      1. Prednisone: Prednisone is a well-known corticosteroid drug that is widely used in medicine to treat various conditions due to its anti-inflammatory and immunosuppressive properties.
      2. Cyclophosphamide: Cyclophosphamide is an alkylating agent used in the treatment of various types of cancer. It has been a staple in chemotherapy regimens for decades.
      3. Rituximab: 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, dysfunctional B-cells, including certain types of non-Hodgkin’s lymphoma and rheumatoid arthritis.
      4. Doxorubicin: Doxorubicin is an antineoplastic chemotherapy drug used to treat various cancers; it intercalates DNA and inhibits topoisomerase II.
      5. Polatuzumab vedotin: Polatuzumab vedotin is an antibody-drug conjugate or immunoconjugate for the treatment of B-cell lymphoma. It is one of the newer treatments introduced in medical practice, with the FDA approving it in 2019 for treating diffuse large B-cell lymphoma.

      All of these substances are known to the medical literature and have been used in treatment protocols, but research continues to better understand their full potential and to find new therapeutic indications.


      Study ID

      CT-EU-00038812

      Recruitment status

      Recruting new patients

      Start of the trial

      9 months ago