#1 Clinical Trials Search in Europe

Diffuse large B-cell lymphoma – Trials in Disease

Go back

Ongoing Clinical Trials for Diffuse Large B-Cell Lymphoma

This article provides an overview of 54 clinical trials currently investigating new treatments for diffuse large B-cell lymphoma (DLBCL), a type of non-Hodgkin lymphoma. These trials are taking place across multiple countries in Europe and involve various treatment approaches including novel drug combinations, CAR T-cell therapies, and immunotherapies. The studies encompass patients with newly diagnosed disease, relapsed or refractory DLBCL, and specific high-risk subtypes.

Clinical trial locations

Study Comparing Epcoritamab and Lenalidomide with a Drug Combination for Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

This trial is investigating treatment options for patients whose DLBCL has returned after previous treatment or has not responded to standard therapies. The study compares two treatment approaches: one combining Epcoritamab and Lenalidomide, and another using the standard drug combination of Rituximab, Gemcitabine, and Oxaliplatin. Epcoritamab is a bispecific antibody administered through subcutaneous injection, while Lenalidomide is taken orally as a capsule. The trial is taking place across multiple European countries including Croatia, Belgium, Hungary, Greece, Bulgaria, Romania, France, Netherlands, Czechia, Poland, and Portugal.

Main inclusion criteria: Patients must have confirmed DLBCL that has returned or not responded to at least one previous treatment, including specific therapies such as stem cell transplant or CAR-T therapy. They must have measurable disease visible on imaging scans and an ECOG performance status of 0-2, indicating they can perform most daily activities. Patients must also have adequate organ function as determined by blood tests.

Main exclusion criteria: Patients with other types of cancer, active serious infections, pregnancy or breastfeeding, severe heart conditions, or recent participation in other clinical trials are excluded from this study.

Primary goal: The main aim is to determine if Epcoritamab combined with Lenalidomide can improve how long patients live without their disease worsening, compared to the standard treatment combination.

Investigational drugs: The study tests Epcoritamab (a bispecific antibody targeting CD19 and CD3) and Lenalidomide (an immunomodulatory drug taken orally), comparing them against standard chemotherapy including Rituximab, Gemcitabine, and Oxaliplatin.

Study Comparing Odronextamab with Chemotherapy to Rituximab with Chemotherapy in Patients with Untreated Diffuse Large B-cell Lymphoma

This study focuses on patients with newly diagnosed DLBCL who have not yet received treatment. The trial compares Odronextamab plus CHOP chemotherapy against the standard Rituximab plus CHOP treatment. The study is being conducted in two phases: the first evaluates safety and dosing, while the second compares effectiveness. Odronextamab is a bispecific antibody given through intravenous infusion, designed to engage T-cells to attack cancer cells. The trial is taking place in countries including France, Italy, Belgium, Germany, Spain, Poland, Austria, Czechia, and Ireland.

Main inclusion criteria: Participants must have newly diagnosed DLBCL confirmed by biopsy, with CD20-positive cancer cells. They should have an International Prognostic Index score between 2 and 5, indicating intermediate to high risk. Patients must have measurable disease on PET scans, adequate organ function, and an ECOG performance status of 0-2.

Main exclusion criteria: Patients who have already received treatment for DLBCL, those with certain other cancers, active serious infections, severe heart problems, or who are pregnant or breastfeeding cannot participate.

Primary goal: The study aims to determine if Odronextamab combined with CHOP chemotherapy can extend progression-free survival compared to the standard Rituximab plus CHOP regimen in newly diagnosed DLBCL patients.

Investigational drugs: Odronextamab (a bispecific antibody) is being tested in combination with CHOP chemotherapy (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) and compared to the standard treatment using Rituximab plus CHOP.

Study Comparing Zilovertamab Vedotin with Drug Combination for Untreated Patients with Diffuse Large B-Cell Lymphoma

This trial investigates a treatment for newly diagnosed patients with the germinal center B-cell subtype of DLBCL. The study compares Zilovertamab vedotin combined with R-CHP chemotherapy against the standard treatment Polatuzumab vedotin plus R-CHP. Zilovertamab vedotin is an antibody-drug conjugate that delivers medication directly to cancer cells. The trial is being conducted in Germany, Belgium, Poland, Ireland, and Italy.

Main inclusion criteria: Patients must have confirmed germinal center B-cell DLBCL diagnosed through biopsy, with disease visible on PET scans (score 4-5 on the Lugano scale). They should not have received any prior treatment for DLBCL. Patients must have adequate heart function with left ventricular ejection fraction of at least 50%, and they must meet specific criteria regarding hepatitis B, hepatitis C, or HIV if applicable.

Main exclusion criteria: Patients with other types of cancer, those who have received previous treatment with similar drugs, pregnant or breastfeeding women, those with severe heart, liver, or kidney disease, and patients with uncontrolled infections are excluded.

Primary goal: The study aims to evaluate the complete response rate after treatment, comparing Zilovertamab vedotin plus R-CHP against Polatuzumab vedotin plus R-CHP in newly diagnosed germinal center B-cell DLBCL patients.

Investigational drugs: Zilovertamab vedotin (an antibody-drug conjugate targeting ROR1) is being tested in combination with R-CHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone), compared to Polatuzumab vedotin plus R-CHP.

Study of CD19-CAR_Lenti, Fludarabine, and Cyclophosphamide in Children with Relapsed or Refractory Acute Lymphoblastic Leukemia or Aggressive B-Cell Lymphomas

This Italian trial focuses on pediatric and young adult patients with relapsed or refractory B-cell cancers, including DLBCL. The treatment involves CAR T-cell therapy, where a patient’s own immune cells are modified to better attack cancer cells expressing CD19. The modified cells are given through intravenous infusion after preparatory chemotherapy with Fludarabine and Cyclophosphamide. This study is specifically designed for younger patients aged 1-35 years depending on disease type.

Main inclusion criteria: Patients must have CD19-expressing B-cell acute lymphoblastic leukemia or aggressive B-cell lymphomas including DLBCL. The cancer must have relapsed or be refractory to treatment, with patients having received at least two prior therapies for certain conditions. Age requirements vary: 1-25 years for some leukemias and 1-35 years for certain lymphomas. Patients must have adequate vein access for apheresis and an ECOG/Karnofsky performance status of 60% or higher.

Main exclusion criteria: Patients who do not have the specified cancer types, those outside the age ranges, pregnant or breastfeeding individuals, and those with severe health conditions that would make the treatment unsafe are excluded.

Primary goal: The study aims to determine the safety and effectiveness of CD19-CAR_Lenti therapy and to find the optimal dose for treating pediatric and young adult patients with relapsed or refractory B-cell malignancies.

Investigational drug: CD19-CAR_Lenti consists of genetically modified T-cells engineered to express a chimeric antigen receptor targeting CD19 on cancer cells, administered as a one-time infusion following conditioning chemotherapy.

Study of loncastuximab tesirine and epcoritamab combination treatment for patients with relapsed or refractory diffuse large B-cell lymphoma

This German trial examines a combination therapy approach for patients whose DLBCL, Follicular Lymphoma grade 3B, or High-grade B-cell Lymphoma has returned or not responded to treatment. The study tests Loncastuximab tesirine (given intravenously) in combination with Epcoritamab (given as a subcutaneous injection). The trial will monitor patients for up to 12 months to assess response rates.

Main inclusion criteria: Patients must be at least 18 years old with confirmed B-cell lymphoma and an ECOG performance status of 0-2. They must have relapsed or refractory disease with at least one measurable tumor larger than 1.5 cm on CT scans. Patients should not be receiving medications that suppress T-cells (except low-dose prednisone). Women of childbearing potential must have negative pregnancy tests and agree to use effective contraception.

Main exclusion criteria: Patients with severe uncontrolled illnesses, recent major surgery (within 4 weeks), known allergies to study drugs, active infections requiring treatment, pregnancy or breastfeeding, or participation in other clinical trials are excluded.

Primary goal: The study aims to evaluate the overall response rate of the combination therapy over 12 months, measuring how many patients achieve complete or partial remission.

Investigational drugs: Loncastuximab tesirine (an antibody-drug conjugate targeting CD19) delivered intravenously and Epcoritamab (a bispecific antibody) administered subcutaneously are being tested in combination.

Study of Rituximab and Golcadomide for Older Frail Patients with Diffuse Large B-cell Lymphoma

This Italian study focuses on elderly patients aged 80 or older with newly diagnosed DLBCL who are too frail for standard intensive chemotherapy. The trial tests a chemotherapy-free approach combining Rituximab (given intravenously) with Golcadomide (taken orally as capsules). This treatment offers a potentially less toxic alternative for frail patients who cannot tolerate standard R-CHOP chemotherapy.

Main inclusion criteria: Patients must be 80 years or older with confirmed CD20-positive DLBCL, and considered frail based on geriatric assessment. They must have PET-positive disease and not be eligible for standard anthracycline-based chemotherapy. Patients should have at least one measurable lymph node (1.5 cm or larger), adequate kidney and liver function, and the ability to swallow capsules. Life expectancy must be at least 3 months.

Main exclusion criteria: Patients who are candidates for standard R-CHOP treatment, those with other types of lymphoma, individuals who have received previous DLBCL treatment, and those unable to follow study procedures are excluded.

Primary goal: The study evaluates the overall response rate after completion of treatment cycles or early discontinuation, aiming to provide an effective treatment option for frail elderly patients.

Investigational drugs: Rituximab (a monoclonal antibody targeting CD20) given intravenously and Golcadomide (also known as CC-99282, an investigational immunomodulatory drug) taken orally are being tested in combination.

Study of Zilovertamab Vedotin and Drug Combination for Untreated Diffuse Large B-Cell Lymphoma Patients

This multinational trial tests Zilovertamab vedotin combined with R-CHP chemotherapy compared to standard R-CHOP treatment in newly diagnosed DLBCL patients. The study is taking place in Denmark, Hungary, Romania, Greece, Poland, Italy, Spain, France, Belgium, Portugal, and Netherlands. Zilovertamab vedotin is an antibody-drug conjugate designed to deliver chemotherapy directly to cancer cells expressing the ROR1 protein.

Main inclusion criteria: Patients must have confirmed DLBCL diagnosis through biopsy with positive PET scan results (score 4-5 on Lugano scale). They should not have received any previous treatment for DLBCL. An ECOG performance status of 0-2 is required, along with adequate heart function (left ventricular ejection fraction at least 45%). Patients must be between 18-75 years old with controlled HIV, hepatitis B, or hepatitis C if applicable.

Main exclusion criteria: Patients with other types of cancer, those who have received prior DLBCL treatment, pregnant or breastfeeding women, individuals with severe heart, liver, or kidney problems, and those unable to follow study procedures are excluded.

Primary goal: The study aims to compare complete response rates between Zilovertamab vedotin plus R-CHP versus standard R-CHOP treatment in newly diagnosed DLBCL patients.

Investigational drugs: Zilovertamab vedotin (MK-2140, an antibody-drug conjugate) is being tested in combination with R-CHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone), compared to R-CHOP (which includes Vincristine).

Study of Zilovertamab Vedotin with Drug Combination for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

This trial investigates Zilovertamab vedotin combined with standard second-line treatments (R-GemOx or BR) for patients whose DLBCL has returned or not responded to initial therapy. The study is being conducted in Italy, Poland, France, and Greece. Zilovertamab vedotin delivers chemotherapy directly to cancer cells, potentially improving treatment effectiveness while minimizing side effects.

Main inclusion criteria: Patients must have measurable DLBCL that has relapsed or is refractory to at least one previous treatment including standard chemotherapy with an anthracycline and anti-CD20 antibody. An ECOG performance status of 0-2 is required, along with adequate organ function. Patients should provide tumor tissue for analysis and have life expectancy of at least 3 months.

Main exclusion criteria: Patients with other types of cancer, those who have not recovered from previous treatments, individuals with severe heart problems, active infections requiring treatment, pregnancy or breastfeeding, allergies to study drugs, or severe liver/kidney disease are excluded.

Primary goal: The study evaluates the safety and effectiveness of Zilovertamab vedotin when combined with R-GemOx or BR, aiming to find the optimal dose and assess treatment response in relapsed/refractory DLBCL.

Investigational drugs: Zilovertamab vedotin (MK-2140) is being tested with R-GemOx (Rituximab, Gemcitabine, Oxaliplatin) or BR (Bendamustine, Rituximab), all administered intravenously.

Study on Acalabrutinib with Rituximab and Drug Combination for Older Adults with Untreated Diffuse Large B-Cell Lymphoma

This trial focuses on older adults (over 60 or unable to tolerate full-dose R-CHOP) with newly diagnosed DLBCL. The study tests whether adding Acalabrutinib (a Bruton’s tyrosine kinase inhibitor taken orally) to reduced-dose R-miniCHOP chemotherapy can improve outcomes compared to R-miniCHOP alone. The trial is being conducted in Greece and Germany.

Main inclusion criteria: Patients must be over 80 years old, or 60-80 years old and not eligible for full-dose R-CHOP treatment. They should have confirmed DLBCL diagnosis including various subtypes, Stage II-IV disease or Stage I with bulky disease, and an ECOG performance status of 0-2. Adequate blood counts and organ function are required, along with left ventricular ejection fraction of at least 50%.

Main exclusion criteria: Patients who have received previous DLBCL treatment, those younger than 60 who can receive full-dose R-CHOP, individuals with severe heart problems or uncontrolled medical conditions, active infections, pregnancy or breastfeeding, and those participating in other trials are excluded.

Primary goal: The study aims to determine if adding Acalabrutinib to R-miniCHOP chemotherapy improves progression-free survival in older adults with newly diagnosed DLBCL.

Investigational drugs: Acalabrutinib (oral BTK inhibitor) is being tested in combination with R-miniCHOP (reduced-dose Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone).

Study on CLIC-1901 CAR T-cells and Tocilizumab for Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin Lymphoma

This Danish trial investigates CLIC-1901 CAR T-cell therapy for patients with relapsed or refractory B-cell cancers including DLBCL. The treatment involves collecting and modifying a patient’s own T-cells to target CD19-expressing cancer cells. Tocilizumab is available to manage potential side effects. The study aims to evaluate safety and feasibility of this personalized immunotherapy approach.

Main inclusion criteria: Patients must be between 1-70 years old with confirmed CD19-positive B-cell malignancies that have relapsed or are refractory to treatment. Life expectancy should be at least 12 weeks. Adequate organ function is required, including ECOG performance status above 50%, good lung function (at least 40% expected with oxygen levels above 90%), heart function above 45%, and acceptable liver and kidney function. Informed consent is required.

Main exclusion criteria: Patients with certain types of cancer not included in the study, those unable to follow study procedures, individuals with serious health conditions that could interfere with treatment, pregnant or breastfeeding women, recent participation in other trials, and those with allergies to study medications are excluded.

Primary goal: The study evaluates the safety and feasibility of CLIC-1901 CAR T-cell therapy in treating relapsed or refractory CD19-positive hematological malignancies.

Investigational drug: CLIC-1901 CAR T-cells are personalized therapy created from a patient’s own T-cells, modified to target CD19 protein, administered as a single intravenous infusion following preparatory chemotherapy.

Study on De-escalated Induction Therapy with Methotrexate, Cytarabine, Thiotepa, and Rituximab for Newly Diagnosed Primary CNS Lymphoma Patients

This trial focuses on primary central nervous system lymphoma (PCNSL), a rare form affecting the brain, spinal cord, or eyes. The study tests whether reducing the duration and total dose of the MATRix protocol (Methotrexate, Ara-C, Thiotepa, and Rituximab) followed by high-dose therapy and stem cell transplantation can be as effective as standard treatment. The trial is being conducted in Italy, Germany, and Austria.

Main inclusion criteria: Patients must be immunocompetent (normal immune system) with newly diagnosed primary diffuse large B-cell lymphoma of the CNS. Age requirements are 18-65 years for all patients, or 66-70 years with Karnofsky Performance Status of 50% or higher. Diagnosis must be confirmed by tissue examination, with disease located only in the CNS. At least one measurable lesion is required, with no previous treatment except surgery or ongoing steroid therapy.

Main exclusion criteria: Patients with other types of lymphoma not specified in the study, those with serious health conditions that could interfere, individuals unable to follow procedures or attend visits, pregnant or breastfeeding women, recent participation in other trials, allergies to study medication, history of substance abuse, recent major surgery, active infections, and conditions affecting the immune system are excluded.

Primary goal: The study aims to determine if a de-escalated treatment approach can maintain effectiveness while potentially reducing side effects in newly diagnosed PCNSL patients.

Investigational drugs: The MATRix protocol (Methotrexate, Ara-C/Cytarabine, Thiotepa, and Rituximab) is administered intravenously as induction therapy, followed by high-dose chemotherapy and autologous stem cell transplantation.

Summary

This overview presents 54 ongoing clinical trials for diffuse large B-cell lymphoma, representing a diverse landscape of therapeutic innovation. The trials are distributed across multiple European countries, with notable concentrations in major research centers in France, Germany, Italy, Spain, and the Netherlands. This geographic distribution reflects the international collaborative effort to advance treatment options for this aggressive form of lymphoma.

Several key trends emerge from this collection of trials. Many studies focus on bispecific antibodies such as Epcoritamab, Glofitamab, and Odronextamab, which represent a new class of immunotherapy that engages the patient’s own T-cells to attack cancer cells. CAR T-cell therapies are also being investigated in multiple trials, offering personalized treatment approaches particularly for relapsed or refractory disease. Additionally, antibody-drug conjugates like Zilovertamab vedotin, Loncastuximab tesirine, and Polatuzumab vedotin are being tested, combining targeted delivery with chemotherapy payloads.

The trials address different patient populations: newly diagnosed patients with high-risk features, elderly or frail patients requiring less intensive approaches, and those with relapsed or refractory disease after multiple prior therapies. Several studies specifically target patients who are ineligible for or have failed stem cell transplantation or CAR T-cell therapy, addressing important unmet medical needs.

Treatment combinations vary widely, with many trials testing novel agents alongside standard chemotherapy regimens like R-CHOP or its modifications. Some studies explore chemotherapy-free approaches, particularly for elderly or frail patients. The trials evaluate not only disease control and survival outcomes but also quality of life and safety profiles, reflecting a comprehensive approach to patient care. These ongoing studies collectively represent significant progress toward personalized medicine in DLBCL treatment, with the potential to improve outcomes across diverse patient populations.

Ongoing Clinical Trials on Diffuse large B-cell lymphoma

  • Study of loncastuximab tesirine and epcoritamab combination treatment for patients with relapsed or refractory diffuse large B-cell lymphoma

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study Comparing Zilovertamab Vedotin with Drug Combination for Untreated Patients with Diffuse Large B-Cell Lymphoma

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Germany Ireland Italy Poland

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

    Recruiting

    4 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of Zilovertamab Vedotin and Drug Combination for Untreated Diffuse Large B-Cell Lymphoma Patients

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark France Greece Hungary Italy +5

  • Study of Rituximab and Golcadomide for Older Frail Patients with Diffuse Large B-cell Lymphoma

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on High-Dose Chemotherapy with Cytarabine and Drug Combination for Elderly Patients with Primary CNS Lymphoma

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany

  • Study on Golcadomide and Valemetostat Tosylate for Patients with Relapsed or Refractory Non-Hodgkin Lymphomas

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Italy Spain

  • Study on Golcadomide for Patients with Relapsed or Refractory Aggressive Large B-Cell Lymphoma at High Risk of Relapse After CAR T-Cell Therapy

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Preventing Heart Problems in Patients with Diffuse Large B-Cell Lymphoma Using Dexrazoxane and a Drug Combination

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on Acalabrutinib with Rituximab and Drug Combination for Older Adults with Untreated Diffuse Large B-Cell Lymphoma

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Greece

More information about
Diffuse large B-cell lymphoma:

Connected medications: