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Clinical Trials for B-cell Lymphoma

This article provides information about 35 ongoing clinical trials investigating treatments for B-cell lymphoma. These studies are testing various approaches including CAR T-cell therapies, monoclonal antibodies, chemotherapy combinations, and targeted therapies across multiple countries in Europe. Many trials focus on relapsed or refractory disease, while others examine first-line treatments for newly diagnosed patients.

Clinical trial locations

Long-Term Follow-Up Study for Patients Treated with CAR T-Cell Therapy Using PHE885, YTB323, and Tisagenlecleucel

This study monitors patients for up to 15 years after receiving CAR T-cell therapy. The trial includes patients who previously received treatment with modified immune cells designed to fight cancer, specifically using products called PHE885, YTB323, and tisagenlecleucel.

Inclusion criteria: Patients must have received CAR T-cell therapy as part of a previous Novartis or Penn-sponsored trial or managed access program. Both adults and children are eligible. Participants must provide informed consent and agree to follow study procedures.

Exclusion criteria: There are no significant exclusion criteria beyond not having received the specified CAR T-cell therapies.

Trial focus: The primary goal is to observe any delayed side effects that may occur after CAR T-cell therapy. Researchers will monitor for new cancers, serious infections, neurological problems, autoimmune conditions, and blood disorders. Regular blood tests will track the modified cells in the bloodstream and assess how long they remain active. The study also monitors disease status and overall survival.

Investigational drugs: This trial follows up on three different lentiviral-based CAR T-cell therapies. Each treatment uses modified T-cells that target specific proteins on cancer cells. PHE885 targets B cell maturation antigen, YTB323 targets CD19, and tisagenlecleucel also targets CD19 through a similar mechanism.

Long-Term Safety Study of BCMACP03, BCN-CP01, and 19CP02 for Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, CLL, SLL, or Multiple Myeloma

This trial evaluates the long-term safety of Galapagos CAR T-cell therapies over 15 years in patients who have already received these treatments. The study focuses on monitoring any delayed adverse effects and tracking the persistence of modified immune cells in the body.

Inclusion criteria: Participants must have previously received GLPG CAR T-cell therapy in a clinical trial or through a managed access program. They must be willing to follow study procedures and sign an informed consent form.

Exclusion criteria: Patients who have not received treatment with Novartis or Penn CAR T-cells cannot participate.

Trial focus: The study monitors patients for up to 15 years after CAR T-cell infusion, tracking adverse events including serious ones. Regular check-ups include blood tests to measure CAR transgene levels and detect any replication-competent lentivirus. Researchers also assess disease progression status and time to subsequent cancer therapy.

Investigational drugs: The trial follows up on GLPG CAR T-cell therapies, which are point-of-care treatments using genetically modified T-cells to target cancer cells. These therapies are administered through infusion and are being studied for various B-cell malignancies including lymphomas and multiple myeloma.

Long-term Study of Ibrutinib for Patients with B-cell Non-Hodgkin’s Lymphoma and Chronic Graft Versus Host Disease

This study evaluates the long-term safety and effectiveness of ibrutinib in patients with B-cell non-Hodgkin’s lymphoma and chronic graft-versus-host disease. The trial continues to provide medication to participants who are benefiting from it in previous studies.

Inclusion criteria: Participants must be actively receiving treatment with ibrutinib and have received at least 6 months of prior treatment. They must have a negative pregnancy test at study start and agree to use effective contraception. Those switching from a comparator treatment need more frequent safety assessments if they have received less than 6 months of ibrutinib.

Exclusion criteria: Patients not currently enrolled in ibrutinib studies that have been completed, not actively receiving ibrutinib treatment, or not continuing to benefit from therapy cannot participate.

Trial focus: The study monitors the safety and effectiveness of ibrutinib over an extended period. Regular assessments track disease status and any adverse events. The primary endpoint is recording the number of participants affected by adverse events, while secondary endpoints include evaluating changes in disease status.

Investigational drugs: Ibrutinib is a medication taken orally that blocks a specific protein involved in cancer cell growth and survival. It is used to treat B-cell non-Hodgkin’s lymphoma and chronic graft-versus-host disease by inhibiting Bruton’s tyrosine kinase, a protein crucial for cancer cell proliferation.

Long-term Study of Zanubrutinib for Patients with B-cell Blood Cancer

This open-label trial evaluates the long-term safety of zanubrutinib in patients with B-cell malignancies who previously participated in a BeiGene-sponsored study. The medication is taken orally as capsules, and researchers monitor safety and effectiveness over time.

Inclusion criteria: Patients must have B-cell malignancies and have participated in or recently completed a previous BeiGene study. They must intend to continue or start zanubrutinib treatment and be able to tolerate the medication. The study includes patients aged 18 and older.

Exclusion criteria: Patients who have not participated in a previous BeiGene zanubrutinib study, do not have B-cell malignancies, or are outside the specified age range cannot participate.

Trial focus: The study monitors safety by tracking side effects and adverse events. Regular assessments evaluate progression-free survival, duration of response, and overall survival. Blood tests and health evaluations occur at scheduled intervals throughout the study period.

Investigational drugs: Zanubrutinib is a BTK inhibitor taken orally that blocks Bruton’s tyrosine kinase, a protein involved in B-cell growth and survival. By inhibiting this protein, zanubrutinib helps slow or stop cancer cell growth in B-cell malignancies.

Study Comparing ARI-0001 and Axicabtagene Ciloleucel for Patients with Relapsed or Refractory Non-Hodgkin Lymphoma

This randomized trial compares two CAR T-cell therapies: ARI-0001, a point-of-care investigational treatment, and Yescarta (axicabtagene ciloleucel), an established commercial therapy. The study aims to determine if ARI-0001 is as effective as Yescarta in treating relapsed or refractory non-Hodgkin lymphoma.

Inclusion criteria: Patients must be 18 years or older with confirmed diagnosis of specific types of B-cell lymphoma including diffuse large B-cell lymphoma, follicular lymphoma grade 3B, or related subtypes. They must have relapsed or refractory disease after at least two previous treatments and have measurable disease. Performance status must be ECOG 0-2.

Exclusion criteria: Patients with other types of cancer, recent infections requiring treatment, severe allergic reactions to similar treatments, or serious heart or lung conditions cannot participate. Pregnant or breastfeeding women are also excluded.

Trial focus: The study randomly assigns patients to receive either ARI-0001 or Yescarta. Researchers monitor how long patients live without cancer progression, the safety and side effects of both treatments, and their impact on quality of life. Both treatments involve collecting the patient’s T-cells, modifying them in a laboratory, and infusing them back into the body.

Investigational drugs: ARI-0001 CAR T-cells are produced at the point of care using the patient’s own modified T-cells to target CD19 on cancer cells. Axicabtagene ciloleucel (Yescarta) is a commercial CAR T-cell therapy that also targets CD19. Both therapies help the immune system recognize and destroy cancer cells.

Study of BI-1206, Rituximab, and Acalabrutinib for Patients with Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphoma

This two-phase trial tests a combination treatment approach for slow-growing B-cell lymphomas that have returned or not responded to previous therapies. The study evaluates BI-1206, a monoclonal antibody that targets CD32b, combined with rituximab and potentially acalabrutinib.

Inclusion criteria: Patients must be at least 18 years old with ECOG performance status 0-2 and have CD20-positive indolent B-cell lymphoma confirmed by biopsy. They must have measurable disease and have received at least one previous rituximab-containing treatment. Adequate liver, kidney, and bone marrow function is required.

Exclusion criteria: Patients with other cancers, active infections, serious heart problems, pregnancy, or recent major surgery cannot participate. Those with autoimmune diseases or drug/alcohol abuse are also excluded.

Trial focus: Phase 1 determines the safest dose of BI-1206 when combined with rituximab. Phase 2 explores the optimal dose when all three medications are used together. Throughout the study, researchers monitor B-cell depletion, protein expression levels, and treatment response while tracking adverse events.

Investigational drugs: BI-1206 targets CD32b protein to enhance immune response against cancer. Rituximab binds to CD20 on B-cells, helping the immune system destroy them. Acalabrutinib blocks signals cancer cells need to grow by inhibiting Bruton’s tyrosine kinase.

Study of IDP-121 for Patients with Relapsed or Refractory Multiple Myeloma, B-cell Lymphoma, or Chronic Lymphocytic Leukemia

This two-phase trial investigates IDP-121, an investigational treatment given intravenously for blood cancers that have returned or not responded to previous therapies. Phase 1 focuses on finding the safest dose, while phase 2 evaluates effectiveness.

Inclusion criteria: Patients must be at least 18 years old with performance status 0-2 and have relapsed or refractory chronic lymphocytic leukemia, B-cell lymphomas, or multiple myeloma ineligible for available treatments. Adequate blood, kidney, and liver function is required. Hemoglobin must be above 8.0 g/dl, platelet count above 75 x 109/L (or 50 x 109/L if bone marrow is affected), and heart function (left ventricular ejection fraction) above 50%.

Exclusion criteria: Patients with other cancers, recent heart attacks, severe heart problems, uncontrolled high blood pressure, severe liver or kidney disease, pregnancy, organ transplants, or active infections cannot participate.

Trial focus: The study monitors safety through regular health assessments including vital signs, physical exams, and laboratory tests like blood counts and electrocardiograms. Researchers evaluate treatment effectiveness by measuring tumor response and tracking progression-free survival and overall survival over time.

Investigational drugs: IDP-121 is being studied to determine the highest tolerable dose and its effectiveness in treating various blood cancers by targeting specific cancer cell growth mechanisms.

Study of Loncastuximab Tesirine for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma or High-Grade B-Cell Lymphoma After CAR T-Cell Therapy

This trial evaluates loncastuximab tesirine in patients whose diffuse large B-cell lymphoma or high-grade B-cell lymphoma has returned or not responded after CAR T-cell therapy. The medication is an antibody-drug conjugate administered through intravenous infusion.

Inclusion criteria: Patients must be 18 years or older with confirmed diagnosis of DLBCL or HGBCL according to 2016 WHO classification. They must have failed CAR T-cell therapy, defined as progressive disease at any time or partial remission/stable disease 3 months after CAR T-cell infusion. Measurable disease by Lugano Classification is required. Adequate kidney, liver, lung, and cardiac function is necessary. Women of childbearing potential need negative pregnancy tests.

Exclusion criteria: Patients without confirmed relapsed/refractory DLBCL or HGBCL, those outside the age range, unable to follow procedures, or with conditions interfering with the study cannot participate. Pregnant or breastfeeding women are excluded.

Trial focus: The study monitors how the cancer responds to loncastuximab tesirine, including whether tumors shrink or disappear and how long positive effects last. Regular follow-up visits include physical exams, blood tests, and imaging studies. Researchers also track overall health and survival while monitoring for any side effects.

Investigational drugs: Loncastuximab tesirine is an antibody-drug conjugate that targets a specific protein on cancer cell surfaces, delivering a toxic substance directly to cancer cells to help destroy them while minimizing damage to normal cells.

Study of TranspoCART19 Infusion for Patients with Relapsed or Refractory B-cell Lymphoma Using Genetically Modified T Lymphocytes

This trial evaluates TranspoCART19, a therapy using genetically modified T-cells to treat B-cell lymphoma that has returned or not responded to previous treatments. The study has two phases: determining the safest dose and assessing effectiveness when combined with chemotherapy.

Inclusion criteria: Patients must have relapsed or refractory B-cell lymphoma including specific subtypes like diffuse large B-cell lymphoma, mantle cell lymphoma, and follicular lymphoma. For diffuse large B-cell lymphoma, patients need relapse or refractoriness after at least two treatments. Age must be between 18 and 80 years with ECOG performance status 0-2. Adequate bone marrow, liver, and kidney function is required along with at least 2 months life expectancy. Adequate venous access for lymphapheresis is necessary.

Exclusion criteria: Patients with different cancer types, outside specified age range, pregnant or breastfeeding, severe medical conditions, recent cancer treatments, active infections, or known allergies to study components cannot participate.

Trial focus: The trial involves collecting T lymphocytes through lymphapheresis, genetically modifying them using Sleeping Beauty transposons to target CD19 on cancer cells, then infusing them back. Pre-treatment includes fludarabine phosphate and cyclophosphamide. Regular monitoring tracks safety and treatment response through blood tests and imaging. Quality of life is assessed before treatment and at 3, 6, and 12 months post-infusion.

Investigational drugs: TranspoCART19 uses the patient’s own T-cells expanded and genetically modified to express a CAR targeting CD19 protein on cancer cells. The Sleeping Beauty transposon system enables this genetic modification, helping immune cells recognize and destroy cancer cells.

Study of valemetostat tosylate tablets in patients with relapsed or refractory B-cell lymphoma, including aggressive B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and Hodgkin lymphoma

This phase II trial evaluates valemetostat tosylate, an oral medication taken as film-coated tablets, for treating various types of B-cell lymphoma that have returned or not responded to previous treatments. The study includes different lymphoma subtypes and assesses the medication’s effectiveness as a single-agent therapy.

Inclusion criteria: Patients must be at least 18 years old with confirmed B-cell lymphoma diagnosis. Disease must be measurable with nodes larger than 1.5 cm or extra-nodal areas larger than 1.0 cm. They must have received previous standard treatments that did not work or disease returned. Performance status should be ECOG 0-2. Adequate kidney, blood cell counts, liver function, and tissue samples for testing are required. Women who can become pregnant and men with partners who can become pregnant must use effective birth control during the study and for 3 months after.

Exclusion criteria: Patients under 18 years, those who participated in previous valemetostat trials, with active brain metastases, serious heart conditions, active infections, other cancers requiring treatment, serious liver or kidney disease, pregnancy, breastfeeding, or inability to swallow medications cannot participate.

Trial focus: The study monitors treatment response through regular imaging scans and health assessments. Treatment continues for up to three years depending on patient response. Researchers evaluate how well the medication works by tracking tumor reduction or disappearance, how long responses last, and safety throughout the treatment period.

Investigational drugs: Valemetostat tosylate is an EZH2 inhibitor that modifies epigenetic processes by regulating gene expression in cancer cells. It targets specific proteins that help control gene activity, potentially helping to stop cancer growth in various B-cell lymphomas.

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

This trial compares treatment combining acalabrutinib with R-miniCHOP (rituximab plus reduced-dose chemotherapy) versus R-miniCHOP alone for older adults with previously untreated diffuse large B-cell lymphoma. The goal is to determine if adding acalabrutinib improves outcomes for patients who cannot receive full-dose R-CHOP treatment.

Inclusion criteria: Patients must be over 80 years old, or 60-80 years old and ineligible for full-dose R-CHOP. They need confirmed CD20+ diffuse large B-cell lymphoma or related types with Ann Arbor Stage I (bulky) or II-IV disease. Disease must be measurable with at least one lymph node 1.5 cm or larger. Only one cycle of R-chemotherapy should have been received. ECOG performance status should be 0-2. Adequate bone marrow, kidney, liver, lung, and heart function is required.

Exclusion criteria: Patients with previous cancer (except certain skin or cervical cancers), active infections, severe allergies, serious heart, lung, liver, or kidney conditions, pregnancy, previous DLBCL treatments, immune system disorders, or current participation in other trials cannot join.

Trial focus: Patients are randomly assigned to receive either acalabrutinib with R-miniCHOP or R-miniCHOP alone. Treatment is given in cycles with regular monitoring through physical exams, blood tests, and imaging studies. The study evaluates whether adding acalabrutinib improves progression-free survival compared to standard treatment.

Investigational drugs: Acalabrutinib blocks Bruton’s tyrosine kinase, helping stop cancer cell growth. It is combined with R-miniCHOP, which includes rituximab (targeting CD20 on cancer cells) and reduced-dose CHOP chemotherapy (combination of drugs that attack cancer cells in different ways).

Summary

This overview of 35 clinical trials for B-cell lymphoma reveals several notable patterns in current research. A significant concentration of trials is taking place across multiple European countries, with Germany, France, Spain, Italy, and the Netherlands hosting the most studies. Many trials focus on CAR T-cell therapies and their long-term follow-up, reflecting the growing importance of this treatment approach in lymphoma care.

The trials span a broad spectrum of disease stages and patient populations, from newly diagnosed patients to those with heavily pretreated, relapsed, or refractory disease. Several studies specifically address the needs of older adults who cannot tolerate standard intensive chemotherapy regimens. Pediatric and young adult populations are also represented in multiple trials.

Combination approaches feature prominently, with many trials testing novel agents alongside established therapies like rituximab. Bispecific antibodies, BTK inhibitors, and various immunotherapy combinations are frequently investigated. The emphasis on long-term safety monitoring in CAR T-cell therapy trials underscores the commitment to understanding the lasting effects of these innovative treatments.

Ongoing Clinical Trials on B-cell lymphoma

  • A study comparing AZD0486 after reduced chemotherapy versus standard chemotherapy in older or unfit patients with newly diagnosed large B-cell lymphoma

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Poland

  • Study on Immunotherapy with HSP-CAR19M and Drug Combination for Adults with B-cell Non-Hodgkin Lymphoma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of IDP-121 for Patients with Relapsed or Refractory Multiple Myeloma, B-cell Lymphoma, or Chronic Lymphocytic Leukemia

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of valemetostat tosylate tablets in patients with relapsed or refractory B-cell lymphoma, including aggressive B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and Hodgkin lymphoma

    Recruiting

    1 1
    Investigated diseases:
    Belgium France

  • Long-Term Follow-Up Study for Patients Treated with CAR T-Cell Therapy Using PHE885, YTB323, and Tisagenlecleucel

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Denmark Finland France Germany +6

  • Long-term Study of Ibrutinib for Patients with B-cell Non-Hodgkin’s Lymphoma and Chronic Graft Versus Host Disease

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Greece Italy Poland +2

  • Study on UCART20x22 for Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma Using a Drug Combination

    Recruiting

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

  • Study of Pembrolizumab for Children with Advanced Melanoma or PD-L1 Positive Solid Tumors and Lymphoma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy The Netherlands Portugal Sweden

  • Study on the Safety and Effectiveness of AZD5492 Alone or with Other Treatments for Adults with Relapsed or Refractory B-Cell Blood Cancers

    Recruiting

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

  • Comparing human normal immunoglobulin (iv) and a drug combination to prevent infections in adults with B-cell acute lymphoblastic leukemia or B-cell lymphoma treated with CAR-T cells

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

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