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Diffuse large B-cell lymphoma refractory – Trials in Disease

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Ongoing Clinical Trials for Diffuse Large B-Cell Lymphoma Refractory

There are currently 13 clinical trials studying new treatments for patients with diffuse large B-cell lymphoma that has not responded to previous treatments or has returned after treatment. These trials are testing various medication combinations and new therapies across multiple European countries, offering hope to patients who have limited treatment options.

Clinical trial locations

Study of BGB-16673 in combination with drug therapy for patients with relapsed or refractory B-cell malignancies

This trial is testing a new medication called BGB-16673 combined with other cancer treatments for patients whose B-cell cancer has returned or not responded to previous therapies. BGB-16673 is an experimental drug known as a BTK-degrader, which works by breaking down a specific protein that helps cancer cells survive.

Main inclusion criteria: To participate, patients must be at least 18 years old and have a confirmed diagnosis of B-cell cancer that has relapsed or is refractory. Participants need to have good physical function, with an ability to perform most daily activities with minimal limitations. Adequate organ function, including kidney, liver, and heart function, is required. Women who can become pregnant must use effective birth control and have a negative pregnancy test before treatment begins.

Main exclusion criteria: Patients cannot participate if they have active cancer involvement in the central nervous system, uncontrolled infections, serious heart problems, or are pregnant or breastfeeding. Those with a history of other cancers within the past three years, active HIV infection, or hepatitis B or C are also excluded. Major surgery within four weeks before the study or mental conditions that could interfere with participation are additional reasons for exclusion.

Trial focus: The study aims to find safe and effective treatment combinations by testing BGB-16673 with other medications including zanubrutinib, sonrotoclax, mosunetuzumab, obinutuzumab, and glofitamab. These medications are given in various forms, including tablets taken by mouth and intravenous infusions. The trial has two parts: the first determines the right dose, while the second evaluates effectiveness and side effects.

Investigational drug: BGB-16673 is the primary investigational medication being tested in combination with other standard cancer treatments to determine its safety and effectiveness for patients with relapsed or refractory B-cell malignancies.

Study of Epcoritamab, Lenalidomide, and Rituximab for Patients with Relapsed and Refractory Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System

This French trial is evaluating a treatment combination for patients with brain lymphoma that has returned or not responded to previous treatment. The study tests whether combining Epcoritamab, Lenalidomide, and Rituximab can effectively treat this challenging condition.

Main inclusion criteria: Participants must be at least 18 years old and have adequate kidney function, with a filtration rate above 40 ml/min. Good liver function is required, along with proper blood cell counts without recent transfusions. Women who can become pregnant must use two reliable forms of birth control and have negative pregnancy tests throughout the study. Patients must have a confirmed diagnosis of brain lymphoma showing the CD20 marker and have received at least one previous treatment including methotrexate.

Main exclusion criteria: Patients are excluded if they do not have the specific type of brain lymphoma being studied, fall outside the age requirements, or belong to vulnerable populations requiring special protection. Those unable to follow study procedures, take medications as prescribed, or swallow capsules cannot participate. Patients with other serious health conditions that might interfere with the study are also excluded.

Trial focus: The study consists of eight treatment cycles during which the combination of medications is administered. Epcoritamab is given as an injection under the skin, Lenalidomide is taken orally, and Rituximab is given through intravenous infusion. Researchers will evaluate how many patients achieve complete or partial tumor reduction according to international guidelines for brain lymphoma.

Investigational drugs: Epcoritamab is the investigational medication being studied for its potential to improve response rates when combined with Lenalidomide and Rituximab, both of which are established treatments for lymphoma.

Study on Golcadomide for Patients with Relapsed or Refractory Large B-Cell Lymphoma in the Brain

This trial in the Netherlands and Belgium is studying Golcadomide, a medication taken as a capsule by mouth, for treating brain lymphoma that has returned or not responded to previous treatments. The study includes both primary brain lymphoma and cases where the cancer has spread to the brain from other parts of the body.

Main inclusion criteria: Patients must be at least 18 years old and have a confirmed diagnosis of large B-cell lymphoma affecting the brain. For one group, prior treatment with high-dose methotrexate-based chemotherapy is required. Participants need adequate blood cell counts, including hemoglobin greater than 5 mmol/l and platelet counts above 75×10⁹/l without recent transfusions. A performance status of 2 or less is required, meaning patients should be able to perform most daily activities with some limitations.

Main exclusion criteria: The specific exclusion criteria focus on patients who do not have the types of lymphoma being studied or who have conditions that would make participation unsafe.

Trial focus: The study aims to determine whether Golcadomide can help reduce cancer size or achieve remission in patients with brain lymphoma. Participants will receive the medication orally and be monitored regularly through various assessments including brain MRI scans to track treatment effectiveness and identify side effects.

Investigational drug: Golcadomide is the investigational medication being tested in this phase 2 study for its ability to treat brain lymphoma that has relapsed or proven refractory to previous treatments.

Study on the Effectiveness and Safety of AZD0486 for Adults with Relapsed or Refractory Non-Hodgkin Lymphoma

This international trial across Italy, Germany, Sweden, Spain, France, and Denmark is testing AZD0486, a monoclonal antibody designed to help the immune system fight cancer more effectively. The treatment is given through intravenous infusion for patients whose Non-Hodgkin Lymphoma has returned or not responded to previous treatments.

Main inclusion criteria: Participants must be between 18 and 80 years old with adequate organ function, including liver, blood, kidney, and heart. They must have a confirmed diagnosis of relapsed or refractory B-cell Non-Hodgkin Lymphoma and received at least two previous treatments. The disease must be measurable and show activity on PET scans. An ECOG performance status of 0 to 2 is required, meaning patients should be able to perform light work and daily activities with some limitations.

Main exclusion criteria: Patients with different types of cancer, those not meeting age requirements, or with conditions that could interfere with safe treatment administration cannot participate. Pregnant or breastfeeding women, those with recent participation in other trials, certain infections, or inability to follow study procedures are excluded.

Trial focus: The study monitors treatment effectiveness and safety by tracking overall response rates, duration of response, time to response, and overall survival. Researchers also assess drug levels in the body, immune responses, and patient-reported outcomes related to fatigue, pain, and cognitive effects.

Investigational drug: AZD0486 is the monoclonal antibody being studied as a single-agent treatment for its ability to target specific proteins on cancer cells and enhance the immune system’s ability to fight the lymphoma.

Study on the Safety and Tolerability of Epcoritamab with Drug Combination for Patients with B-cell Non-Hodgkin Lymphoma

This multi-country trial across Denmark, Hungary, France, Netherlands, Germany, Spain, and Czechia is evaluating Epcoritamab, a bispecific antibody, when combined with various cancer-fighting drugs. The study aims to understand how safe and tolerable these combinations are and to determine the best dose for future research.

Main inclusion criteria: Adults at least 18 years old with a diagnosis of Diffuse Large B-Cell Lymphoma that is CD20-positive can participate. Patients must have an ECOG performance status of 0 to 2, meaning they can perform daily activities with minimal to moderate limitations. At least one measurable tumor site visible on PET/CT scan is required, with tumors at least 1.5 cm in lymph nodes or 1.0 cm outside lymph nodes.

Main exclusion criteria: Patients with cancer types other than B-cell Non-Hodgkin Lymphoma or who are outside the specified age range cannot participate. Those unable to safely receive treatment due to other health conditions, pregnant or breastfeeding women, and those with recent participation in other trials are excluded.

Trial focus: The study involves multiple treatment phases using various combinations of medications including Revlimid, Decortin, Cyclophosphamide, Truxima, IMBRUVICA, Venetoclax, Adriblastin, Polivy, and Golcadomide. Some participants may receive a placebo. All medications are given either orally, intravenously, or by subcutaneous injection according to the study protocol.

Investigational drug: Epcoritamab is the primary investigational medication being studied in combination with other established cancer treatments to assess safety, tolerability, and effectiveness.

Study to Optimize Cytokine Release Syndrome for Glofitamab with Gemcitabine and Oxaliplatin in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma

This trial in Italy, Germany, and France is studying how to manage Cytokine Release Syndrome, a potential side effect that can occur when the immune system reacts strongly to certain treatments. The study combines Glofitamab, Gemcitabine, and Oxaliplatin for patients whose lymphoma has returned or not responded to previous treatments.

Main inclusion criteria: Participants must have a life expectancy of at least 12 weeks and a confirmed diagnosis of relapsed or refractory diffuse large B-cell lymphoma. Previous treatment with at least one systemic therapy is required. If patients have only had one previous treatment, they must not be suitable for high-dose chemotherapy followed by stem cell transplant. At least one measurable lymph node larger than 1.5 cm or one area outside lymph nodes larger than 1 cm on CT scan is required.

Main exclusion criteria: Patients with different types of cancer, those outside the specified age range, or belonging to vulnerable populations requiring special protection cannot participate.

Trial focus: The study monitors how often Cytokine Release Syndrome occurs and its severity when patients receive the treatment combination. All medications are given through intravenous infusion, with specific dosages and frequencies determined by the study protocol. Regular monitoring tracks patient health, treatment effectiveness, and side effects.

Investigational drugs: Glofitamab is the primary investigational medication being studied in combination with Gemcitabine and Oxaliplatin, both established chemotherapy drugs used to stop cancer cell growth.

Study Comparing R-MINI-CHOP and R-MINI-CHP with Polatuzumab Vedotin for Treating Diffuse Large B-Cell Lymphoma in Patients Aged 80 and Older or Frail Patients Aged 75 and Older

This Nordic trial across Sweden, Denmark, Italy, Finland, Norway, and Estonia is comparing treatment options specifically designed for older or frail patients. The study evaluates whether combining Polatuzumab Vedotin with R-MINI-CHP is more effective than R-MINI-CHOP alone.

Main inclusion criteria: Patients must be 80 years or older, or if considered frail based on health assessment, 75 years or older. A confirmed diagnosis of diffuse large B-cell lymphoma or related types at Stage II-IV is required. At least one measurable tumor site more than 1.5 cm in length must be present. Patients must not have received any previous treatment for lymphoma and must have adequate blood cell counts and organ function.

Main exclusion criteria: Patients with other cancer types, those who have had previous lymphoma treatment, serious heart problems, uncontrolled infections, pregnant or breastfeeding women, and those with severe allergic reactions to study drugs are excluded.

Trial focus: Participants are randomly assigned to receive either R-mini-CHOP or the combination of Polatuzumab Vedotin with R-mini-CHP. The medications include Vincristine Sulfate, Cyclophosphamide, Doxorubicin Hydrochloride, Prednisone, and Rituximab, given through various methods including intravenous infusion and subcutaneous injection.

Investigational drugs: Polatuzumab Vedotin is the investigational medication being compared with standard treatment regimens to determine if it provides better outcomes for older or frail patients with this type of lymphoma.

Study Comparing Polatuzumab Vedotin with Rituximab, Ifosfamide, Carboplatin, and Etoposide for Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

This trial in Germany, Austria, and Spain is comparing two treatment approaches for patients whose lymphoma has returned or not responded to initial treatment. The study evaluates whether adding Polatuzumab vedotin to the standard R-ICE regimen improves outcomes.

Main inclusion criteria: Adult patients must be at least 18 years old with adequate blood function, including specific minimum levels of hemoglobin, neutrophils, and platelets. Women who can become pregnant must have a negative pregnancy test within seven days before starting treatment and agree to use birth control. Patients must have a confirmed diagnosis of specific types of aggressive B-cell lymphoma and received previous treatment including anti-CD20 antibody and anthracycline-containing chemotherapy.

Main exclusion criteria: Non-adults, those without relapsed or refractory disease, pregnant or breastfeeding women, patients with other serious health conditions, recent major surgery, certain infections, heart problems, or allergic reactions to study drugs cannot participate.

Trial focus: The study compares the Pola-R-ICE regimen (Polatuzumab vedotin, Rituximab, Ifosfamide, Carboplatin, and Etoposide) with R-ICE alone to determine if the addition of Polatuzumab vedotin improves event-free survival. All medications are given through intravenous infusion in cycles, with regular monitoring for effectiveness and side effects.

Investigational drugs: Polatuzumab Vedotin is the investigational antibody-drug conjugate being tested in combination with Rituximab, Ifosfamide, Carboplatin, and Etoposide to improve treatment outcomes.

Study of Rituximab, Gemcitabine, Dexamethasone, and Platinum with or without Selinexor for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

This trial in Italy, Spain, and Poland is studying whether adding Selinexor, an experimental oral medication, to standard chemotherapy can improve outcomes for patients with relapsed or refractory disease. The study has two phases focusing on response rates and progression-free survival.

Main inclusion criteria: Patients must be at least 18 years old with an estimated life expectancy of more than three months. Those with primary refractory disease are eligible if they did not respond or relapsed within six months after first treatment. Adequate bone marrow, liver, and kidney function is required, along with proper blood cell counts. Both men and women must agree to use effective contraception during the study and for 12 months after treatment.

Main exclusion criteria: Patients with uncontrolled cancer, recent heart attacks or severe heart problems, active infections requiring antibiotics, pregnant or breastfeeding women, known allergies to study drugs, major surgery within four weeks, or conditions affecting medication absorption are excluded.

Trial focus: Participants receive a combination of Rituximab, Gemcitabine, Dexamethasone, and a platinum-based drug, with or without Selinexor. The study uses a placebo for comparison in some patients. Regular monitoring evaluates treatment effectiveness, side effects, and how long patients live without disease progression.

Investigational drugs: Selinexor is the experimental medication being tested, while Rituximab, Gemcitabine, Dexamethasone, and platinum-based drugs are established cancer treatments used in combination.

Study on ALLO-647 and ALLO-501A for Adults with Relapsed or Refractory Large B-Cell Lymphoma

This trial in Germany, Belgium, and Austria is testing a novel CAR T cell therapy approach. The study evaluates ALLO-501A, a therapy using specially modified immune cells, combined with ALLO-647 and chemotherapy drugs to prepare the body for treatment.

Main inclusion criteria: Patients must have confirmed relapsed or refractory large B-cell lymphoma at their last relapse and received at least two different chemotherapy treatments. An ECOG performance status of 0 or 1 is required, meaning patients must be fully active or able to perform light work. Adequate blood cell counts, kidney function, and liver function are necessary. Patients must not have significant donor-specific antibodies that could react against the treatment.

Main exclusion criteria: Patients with other cancer types, those with recent stem cell transplants within three months, severe heart problems, uncontrolled infections, pregnant or breastfeeding women, active hepatitis or HIV infection, or conditions making participation unsafe are excluded.

Trial focus: The study involves lymphodepletion treatment using Fludarabine and Cyclophosphamide, with some patients also receiving ALLO-647. This prepares the body to accept the main CAR T cell therapy, ALLO-501A. Regular monitoring assesses treatment response and safety throughout the study.

Investigational drugs: ALLO-501A is the investigational CAR T cell therapy, while ALLO-647 helps prepare the body by reducing immune cells that might interfere with treatment. Fludarabine and Cyclophosphamide are used for lymphodepletion.

Study on Brentuximab Vedotin, Lenalidomide, and Rituximab for Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma

This large international trial across Italy, Denmark, Spain, France, Poland, Czechia, Belgium, and Espagne is testing whether adding Brentuximab Vedotin to a combination of Lenalidomide and Rituximab can improve progression-free survival compared to treatment without Brentuximab Vedotin.

Main inclusion criteria: Patients must be at least 18 years old with relapsed or refractory diffuse large B-cell lymphoma and received at least two previous treatments. Those not eligible for stem cell transplant or CAR-T therapy due to medical or other reasons can participate. A tumor tissue sample must be sent to check for CD30 protein. Adequate blood test results are required, including specific levels of white blood cells, platelets, hemoglobin, bilirubin, kidney function, and liver enzymes.

Main exclusion criteria: Patients with other cancer types, those not meeting age requirements, inability to follow study procedures, pregnant or breastfeeding women, or recent participation in other clinical trials may be excluded.

Trial focus: Participants receive either the combination of Brentuximab Vedotin, Lenalidomide, and Rituximab or a placebo instead of Brentuximab Vedotin. Brentuximab Vedotin and Rituximab are given by subcutaneous injection, while Lenalidomide is taken orally. The study compares effectiveness in preventing disease progression between the two groups.

Investigational drugs: Brentuximab Vedotin is the investigational antibody-drug conjugate being tested in combination with Lenalidomide and Rituximab to determine if it improves progression-free survival.

Summary

These 13 clinical trials represent a diverse range of treatment approaches for patients with diffuse large B-cell lymphoma that has not responded to previous treatments or has returned after treatment. The trials are distributed across multiple European countries, with particular concentration in Germany, Italy, France, and Spain, reflecting strong research infrastructure in these regions.

Several trials focus on combination therapies involving monoclonal antibodies and antibody-drug conjugates such as Polatuzumab Vedotin, Epcoritamab, Glofitamab, and Brentuximab Vedotin. There is also significant interest in novel approaches including CAR T cell therapy and BTK-degrader medications. Some studies specifically address challenging patient populations, including older or frail patients and those with brain involvement.

The trials employ various study designs, with many using randomized comparisons between experimental combinations and standard treatments. Most studies require patients to have received at least one or two previous treatments and maintain adequate organ function. The geographic distribution of these trials provides opportunities for patients across Europe to access potentially beneficial experimental treatments.

Ongoing Clinical Trials on Diffuse large B-cell lymphoma refractory

  • Study of BGB-16673 in combination with drug therapy for patients with relapsed or refractory B-cell malignancies

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Italy Poland

  • Study to Optimize Cytokine Release Syndrome for Glofitamab with Gemcitabine and Oxaliplatin in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma

    Recruiting

    1 1 1
    Investigated diseases:
    France Germany Italy

  • Study on the Safety and Tolerability of Epcoritamab with Drug Combination for Patients with B-cell Non-Hodgkin Lymphoma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark France Germany Hungary The Netherlands +1

  • Glofitamab plus drug combination for relapsed/refractory large B‑cell lymphoma in high‑risk second‑line patients eligible for CAR‑T therapy

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on the Safety and Effectiveness of Polatuzumab Vedotin with Rituximab, Gemcitabine, and Oxaliplatin for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Greece Italy Spain

  • Study on ALLO-647 and ALLO-501A for Adults with Relapsed or Refractory Large B-Cell Lymphoma

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Germany

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