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High-grade B-cell lymphoma – Trials in Disease

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Ongoing Clinical Trials for High-grade B-cell Lymphoma

There are currently 9 ongoing clinical trials for High-grade B-cell Lymphoma. These trials are evaluating new treatment combinations, including novel antibody therapies, targeted medications, and immunotherapies. Trials are taking place across multiple European countries, with some studies focusing on patients who have relapsed or not responded to previous treatments, while others examine first-line treatments for newly diagnosed patients.

Clinical trial locations

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

This trial is testing a combination of two medications for patients whose disease has returned or not responded to previous treatment. The study includes patients with Diffuse Large B-cell Lymphoma, Follicular Lymphoma grade 3B, and High-grade B-cell Lymphoma.

Inclusion criteria: Participants must be at least 18 years old and have confirmed B-cell lymphoma that has returned or not responded to previous treatment. They must have measurable disease visible on PET/CT scans and a general health status allowing them to perform daily activities with some limitations. Patients must have failed prior treatment with either first-line therapy containing specific antibodies and chemotherapy, or second-line CAR-T cell therapy. Adequate blood counts, liver function, kidney function, and heart function are required. Women of childbearing potential must have a negative pregnancy test and use effective birth control during the study and for 12 months after. Men must also use effective birth control during and for 7 months after the study.

Exclusion criteria: The trial excludes patients below 18 years or above 65 years, those who have had previous CAR-T cell therapy, active or chronic infections including hepatitis B, hepatitis C, or HIV, pregnancy or breastfeeding, recent major surgery, active heart problems, severe kidney or liver problems, active second cancer, mental conditions interfering with study participation, or recent participation in another clinical trial.

Trial focus: The study evaluates how well patients respond to this combination treatment over a 12-month period. The medications work in different ways to target and destroy cancer cells. Loncastuximab tesirine is an antibody-drug combination that delivers medication directly to cancer cells, while epcoritamab is a specialized antibody that helps the immune system recognize and fight cancer cells. The treatment period may last up to 54 weeks, depending on patient response and tolerance.

Investigational drugs: Loncastuximab Tesirine is an antibody-drug that targets and attacks specific cancer cells through intravenous infusion, delivering a toxic substance directly to cancer cells while minimizing damage to healthy cells. Epcoritamab is a bispecific antibody given as an injection under the skin that helps the immune system fight lymphoma by connecting immune cells to cancer cells.

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

This trial is designed for older adults who have not been treated for Diffuse Large B-Cell Lymphoma before. The study compares the effectiveness of adding acalabrutinib to the R-miniCHOP treatment regimen versus using R-miniCHOP alone.

Inclusion criteria: Participants must be men and women over 80 years old, or over 60 up to 80 years old and not eligible for full-dose R-CHOP treatment. They must have confirmed CD20+ diffuse large B-cell lymphoma or related types with specific disease stages. Adequate laboratory test results are required, including normal levels of blood cells, liver enzymes, and kidney function. Patients must have an ECOG performance status of 0, 1, or 2 (a score of 3 is acceptable only if directly due to lymphoma). They must be able to understand and consent to the study, swallow capsules without difficulty, and use effective contraception if sexually active.

Exclusion criteria: The trial excludes patients with cancer types other than the specific large B-cell lymphoma types listed, those who have already received treatment for DLBCL, patients younger than 60 years who are eligible for full-dose R-CHOP, patients unable to take study medication due to allergies, pregnant or breastfeeding patients, those with severe heart problems or uncontrolled medical conditions, active infections requiring treatment, or patients participating in another clinical trial simultaneously.

Trial focus: The study aims to determine if adding acalabrutinib to R-miniCHOP treatment can help patients live longer without disease progression compared to R-miniCHOP alone. Treatment is administered over cycles with regular check-ups to monitor health and disease progression. The R-miniCHOP regimen includes rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, and pegfilgrastim.

Investigational drugs: Acalabrutinib is a medication that works by blocking a specific protein that helps cancer cells grow. It is used to see if it can help stop disease progression when used together with other cancer treatments. Rituximab targets a specific protein on cancer cells to help the immune system destroy them. R-miniCHOP is a reduced-dose combination of chemotherapy drugs designed for older adults.

Study of Loncastuximab Tesirine and Epcoritamab for Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma, High-grade B-cell Lymphoma, or Follicular Lymphoma Grade 3B

This study evaluates the combination of Loncastuximab Tesirine and Epcoritamab for patients whose lymphoma has returned or not responded to previous treatments. It includes patients with Diffuse Large B-cell Lymphoma, High-grade B-cell Lymphoma, and Follicular Lymphoma grade 3B.

Inclusion criteria: Participants must be at least 18 years old with confirmed diagnosis of one of the specified lymphoma types. They should not be taking medication that reduces T-cell activity, except for small doses of prednisone if needed. Patients must need treatment based on symptoms or disease severity and have an ECOG performance status of 0-2. They must have relapsed or refractory disease after failing previous treatments, including first-line anti-CD20 therapy or second-line CAR-T cell therapy. At least one measurable disease site must be confirmed by PET/CT scan or MRI. Adequate blood counts, liver function, kidney function, and heart function are required. Effective birth control must be used during and after the study.

Exclusion criteria: The trial excludes patients with cancer types other than the specified lymphomas, those outside the study age range, patients unable to provide informed consent, pregnant or breastfeeding patients, those with severe uncontrolled medical conditions, patients who received certain treatments recently, those with known allergies to study medications, and patients who participated in another clinical trial within a specified timeframe.

Trial focus: The study aims to determine the best overall response rate, including complete and partial remissions, achieved up to 12 months of treatment. Loncastuximab Tesirine is given intravenously while Epcoritamab is administered subcutaneously. The treatment continues for up to 12 months unless there are reasons to stop earlier, such as significant side effects or disease progression.

Investigational drugs: Loncastuximab Tesirine is an antibody-drug conjugate designed to target and deliver toxic substances directly to cancer cells. Epcoritamab is a bispecific antibody that engages the immune system to recognize and attack cancer cells by binding to proteins on both immune cells and cancer cells.

Study on the Effectiveness and Safety of Cytarabine, Tafasitamab, and Lenalidomide for Patients with Relapsed Diffuse Large B-Cell Lymphoma

This trial is evaluating the effectiveness and safety of starting second-line treatment early in patients who have experienced a relapse of Diffuse Large B-Cell Lymphoma or High-Grade B-Cell Lymphoma. Treatment decisions are guided by levels of tumor DNA found in the blood.

Inclusion criteria: Patients must have a diagnosis of DLBCL or HGBCL and be eligible for chemotherapy treatments like R-CHOP, R-CHOP-like, Pola-R-CHP, or DA-EPOCH-R. They must have test results available including mutation analysis in blood before first-line treatment, assessment of circulating free DNA from the tumor during and after treatment, and PET-CT scans before and after first-line treatment. Patients must be at least 18 years old, have an ECOG performance status of 0-2 (or 3 if due to disease progression), and be in complete remission confirmed by PET-CT scan after first-line treatment. They must sign informed consent and agree to use effective contraception.

Exclusion criteria: The trial excludes patients with other types of cancer not related to DLBCL or HGBCL, those who have not completed previous treatments or recovered from side effects, patients with severe heart problems or uncontrolled blood pressure, active infections requiring treatment, pregnant or breastfeeding patients, those with allergic reactions to similar treatments, patients with other serious medical conditions that could interfere with the study, and those unable to follow study procedures.

Trial focus: The study monitors overall response rate to second-line treatment and any significant side effects. Regular assessments include blood tests to measure circulating tumor DNA and imaging tests like PET-CT scans to monitor disease progression. Quality of life is evaluated using the EORTC QLQ-C30 questionnaire.

Investigational drugs: The trial uses cell-free circulating tumor DNA as a marker to help decide when to start new treatment. The treatment involves several medications including cytarabine, tafasitamab, lenalidomide, dexamethasone, cisplatin, bendamustine hydrochloride, polatuzumab vedotin, and rituximab, administered through various routes including intravenous infusion and oral capsules.

Study of Rapcabtagene Autoleucel and Ibrutinib for Adults with Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Other Blood Cancers

This trial is studying several types of blood cancers including Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Diffuse Large B-Cell Lymphoma, Acute Lymphoblastic Leukemia, and High-Risk Large B-Cell Lymphoma. The main treatment being tested is Rapcabtagene Autoleucel, which involves using modified immune cells to fight cancer.

Inclusion criteria: Patients must have one of the specified blood cancer conditions. For DLBCL, patients must have disease that has returned or not responded after receiving at least two treatments and have measurable disease at study entry. For 1L HR LBCL, patients must be considered high-risk based on specific criteria at diagnosis, have received two cycles of initial treatment with specific chemotherapy regimens, and have a positive result on PET scan after two cycles. Both male and female adults are eligible.

Exclusion criteria: The trial excludes patients not within the specified age range, those not meeting clinical trial group requirements, patients not male or female, and those considered part of a vulnerable population requiring special protection or care.

Trial focus: The study is divided into two phases. Phase one aims to determine the appropriate dose and assess safety of rapcabtagene autoleucel, both alone and in combination with ibrutinib. Phase two focuses on evaluating how well the treatment works in reducing or eliminating cancer. Treatment is delivered through infusion with close monitoring for side effects and changes in health.

Investigational drugs: Rapcabtagene autoleucel is a form of therapy that modifies a patient’s own immune cells to help fight cancer. It is being tested for safety and effectiveness in treating various blood cancers. Ibrutinib is a medication used in combination with rapcabtagene autoleucel to help stop cancer cells from growing and spreading.

Study of Tisagenlecleucel for Adults with Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma

This trial is focused on treating aggressive B-cell non-Hodgkin lymphoma using tisagenlecleucel, a form of cell therapy that uses specially modified cells to target and fight cancer cells. The study compares tisagenlecleucel with standard care treatments.

Inclusion criteria: Participants must be at least 18 years old with confirmed diagnosis of CD20+ diffuse large B-cell lymphoma or related types. The disease must have returned or worsened within 365 days after last treatment with certain medications, or not fully responded to initial treatment. Patients should be eligible for stem cell transplant as determined by their doctor. Disease must be active and visible on scans with specific size requirements. Overall health should be good with ECOG performance status of 0 or 1. Organs must be functioning well, including adequate kidney, liver, blood, and lung function. A sample of blood cells must be available for use in the study.

Exclusion criteria: The trial excludes patients with different cancer types than those being studied, those who have not experienced disease return or worsening, non-adults, patients unable to understand or agree to study requirements, those with other serious health conditions that could interfere, pregnant or breastfeeding patients, those who received certain treatments recently that could affect results, patients with allergies to study medication or ingredients, and those participating in another clinical trial simultaneously.

Trial focus: The study aims to see if tisagenlecleucel can delay disease progression or improve survival compared to standard treatments. Regular assessments monitor participants’ health and treatment effectiveness through medical tests and evaluations. The trial involves leukapheresis to collect white blood cells, pre-treatment regimen, tisagenlecleucel infusion, and regular monitoring and follow-up.

Investigational drugs: Tisagenlecleucel is a type of therapy that uses the patient’s own immune cells, collected, modified in a laboratory to better recognize cancer cells, and infused back into the patient. Standard of Care refers to usual treatment for aggressive B-cell non-Hodgkin lymphoma, including chemotherapy, radiation therapy, and other medications typically used for this cancer type.

Study on Golcadomide and R-CHOP Drug Combination for Patients with Untreated High-risk Large B-cell Lymphoma

This trial compares the effectiveness and safety of a new treatment called Golcadomide when used alongside standard R-CHOP chemotherapy against a placebo combined with R-CHOP. The study includes patients with High-risk Large B-cell Lymphoma who have not yet been treated.

Inclusion criteria: Participants must have a specific type of Large B-cell Lymphoma with confirmed diagnosis that has not been treated before. They must have a certain IPI score indicating risk level (1 or 2 with certain conditions, or 3 or higher). At least one measurable tumor larger than 1.5 cm is required. ECOG Performance Status should be 0, 1, or 2 (a score of 3 is allowed if due to cancer). The cancer should be at Ann Arbor Stage II-IV. Adequate blood counts, liver function, kidney function are required. Patients must be between 18 and 80 years old and willing to follow the study visit schedule. If of childbearing potential, they must agree to pregnancy counseling and follow the Pregnancy Prevention Program.

Exclusion criteria: The trial excludes patients with different cancer types than High-risk Large B-cell Lymphoma, those outside the specified age range, patients not part of specified clinical trial groups, those unwilling or unable to follow study procedures, patients with other medical conditions that might interfere, pregnant or breastfeeding patients, those who participated in another clinical trial recently, patients with certain allergies to study medication, those with history of diseases that could affect results, and patients unable to provide informed consent.

Trial focus: The study measures the time it takes for cancer to worsen or for the patient to pass away, known as Progression-Free Survival. Other aspects include overall survival and whether the cancer completely responds to treatment. Treatment involves medications administered in 21-day cycles, including rituximab, doxorubicin hydrochloride, vincristine sulfate, cyclophosphamide monohydrate, and prednisone, with either golcadomide capsules or placebo.

Investigational drugs: Golcadomide is a medication being tested to see if it can help treat high-risk large B-cell lymphoma when used in combination with R-CHOP chemotherapy. R-CHOP Chemotherapy is a combination of drugs commonly used to treat certain types of lymphoma, working together to kill cancer cells and stop them from growing.

Study on the Effect of DA-EPOCH-R and Nivolumab in Patients with Newly Diagnosed High-Grade B-Cell Lymphoma with MYC and BCL2/BCL6 Rearrangements

This trial is focused on a specific high-grade form of Diffuse Large B-Cell Lymphoma with certain genetic changes known as MYC and BCL2 and/or BCL6 rearrangements. The study evaluates DA-EPOCH-R treatment followed by Nivolumab to help prevent cancer from returning.

Inclusion criteria: Participants must have High-grade B-cell lymphoma involving specific genetic changes (MYC, BCL2, and/or BCL6 rearrangements) determined by FISH test. They must provide written informed consent and be at least 18 years old. Patients must have started or completed one course of R-CHOP or DA-EPOCH-R chemotherapy with certain conditions. WHO performance status should be 0-3 during or after first treatment cycle. Diagnosis at Ann Arbor stage II-IV is required. Specific scans must have been done, preferably within 28 days before starting treatment. Measurable disease is required. Female patients must have negative pregnancy test and use adequate contraception.

Exclusion criteria: The trial excludes patients who have not achieved Complete Metabolic Response after DA-EPOCH-R treatment, those with medical conditions other than DLBCL, patients outside the specified age range, those unable to provide informed consent or part of vulnerable populations, and patients not eligible for nivolumab consolidation treatment.

Trial focus: The study aims to see if adding Nivolumab after initial treatment can improve the chances of cancer not returning within 12 months. Participants first receive DA-EPOCH-R treatment for about 18 weeks, involving medications given through infusion and Prednisolone taken as tablets. After completing this phase, patients receive Nivolumab infusions for up to 52 weeks. Regular monitoring through check-ups and imaging tests like PET-CT scans helps visualize cancer activity.

Investigational drugs: DA-EPOCH-R is a combination of chemotherapy drugs designed to kill cancer cells and stop them from growing and spreading. Nivolumab is an immunotherapy that helps the immune system fight cancer by blocking a protein that prevents the immune system from attacking cancer cells.

Study on the Effectiveness and Safety of Glofitamab with Drug Combination for Untreated Large B-Cell Lymphoma Patients

This trial is comparing the effectiveness and safety of a new treatment combination for Large B-Cell Lymphoma. The combination includes Glofitamab and Polatuzumab Vedotin, along with Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone.

Inclusion criteria: Participants must have previously untreated large B-cell lymphoma that is CD20-positive. They need to provide a tumor tissue sample from previous collection or newly collected. An IPI score between 2 and 5 is required. ECOG Performance Status should be 0, 1, or 2. Life expectancy must be at least 6 months. Adequate hematologic function is required, meaning blood cell levels should be within certain ranges. A negative HIV test at screening is required. Both male and female participants are eligible.

Exclusion criteria: The trial excludes patients with cancer types other than Large B-Cell Lymphoma, those who had different cancer treatment within the last 4 weeks, patients with severe heart problems, uncontrolled infections, pregnant or breastfeeding patients, those who had organ transplants, patients with history of severe allergic reactions to similar medications, those with immune system conditions like HIV, patients currently participating in another clinical trial, and those with any other medical condition that study doctors think would make participation unsafe.

Trial focus: The study evaluates how well the combination of Glofitamab with other drugs works compared to standard treatment. Participants receive one of these treatment combinations through intravenous infusion at specified intervals. The study monitors how long participants live without cancer getting worse (progression-free survival). Regular monitoring includes check-ups, blood tests, and imaging studies to assess lymphoma progression and treatment effectiveness.

Investigational drugs: Glofitamab is a medication being studied for its potential to help treat large B-cell lymphoma by helping the immune system recognize and attack cancer cells more effectively. Polatuzumab Vedotin targets and destroys cancer cells while sparing healthy cells. Rituximab helps the immune system find and destroy cancer cells by targeting specific proteins on their surface. Cyclophosphamide and Doxorubicin are chemotherapy drugs that help stop cancer cell growth. Prednisone is a steroid that helps reduce inflammation and improve effectiveness of other cancer-fighting drugs.

Summary

The 9 ongoing clinical trials for High-grade B-cell Lymphoma demonstrate a diverse approach to treatment research across Europe. Germany has the most active involvement with participation in 7 trials, followed by Italy, France, Spain, and Austria, each participating in 4 trials. The Netherlands and Poland are involved in 3 trials each, while Belgium, Greece, and Denmark each participate in 2 trials. Several countries including Bulgaria, Czechia, Finland, Hungary, Norway, Portugal, Romania, and Sweden have single trial locations.

The trials show a clear focus on combination therapies. Several studies are testing novel antibody-based treatments such as loncastuximab tesirine and epcoritamab, tisagenlecleucel, and glofitamab, often in combination with standard chemotherapy regimens. There is also significant interest in targeted therapies like acalabrutinib and golcadomide, as well as immunotherapies including nivolumab and modified immune cell therapies like rapcabtagene autoleucel.

The trials address different patient populations, with some focusing on newly diagnosed patients and others on those whose disease has returned or not responded to previous treatments. Several studies specifically target older adults or patients with high-risk genetic features. The diversity of approaches reflects ongoing efforts to improve treatment outcomes for patients with this aggressive form of lymphoma through personalized medicine strategies and innovative therapeutic combinations.

Ongoing Clinical Trials on High-grade 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 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

  • Study of Loncastuximab Tesirine and Epcoritamab for Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma, High-grade B-cell Lymphoma, or Follicular Lymphoma Grade 3B

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on the Effectiveness and Safety of Cytarabine, Tafasitamab, and Lenalidomide for Patients with Relapsed Diffuse Large B-Cell Lymphoma

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

  • Study of Tisagenlecleucel for Adults with Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria France Germany Italy The Netherlands Norway +1

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