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Primary mediastinal large B-cell lymphoma – Trials in Disease

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Ongoing Clinical Trials for Primary Mediastinal Large B-Cell Lymphoma

There are currently 8 ongoing clinical trials studying new treatments for primary mediastinal large B-cell lymphoma. These trials are testing innovative therapies including CAR T-cell treatments, immunotherapies, and targeted drug combinations across multiple countries in Europe. Patients with relapsed or refractory disease, as well as those newly diagnosed, may find opportunities to participate in these studies.

Clinical trial locations

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

This trial is testing a specialized treatment called CD19-CAR_Lenti for children and young adults with aggressive B-cell lymphomas, including primary mediastinal B-cell lymphoma, whose cancer has returned or not responded to previous treatments. The therapy involves modifying the patient’s own immune cells to recognize and attack cancer cells expressing the CD19 protein.

Main inclusion criteria: Patients must be between 1 and 35 years old (for lymphoma patients) with a confirmed diagnosis showing CD19 expression. The disease must be relapsed or refractory. Patients need adequate physical ability, measured by a Karnofsky score of at least 60% for older participants or Lansky score for younger ones. Suitable veins for the apheresis procedure are required. Female patients of childbearing age must have a negative pregnancy test, and all participants capable of having children must use effective birth control.

Main exclusion criteria: Patients without the specified types of relapsed or refractory CD19-positive lymphomas cannot participate. Those outside the age range, pregnant or breastfeeding individuals, recent participants in other clinical trials, and those with health conditions that could make the study unsafe are excluded.

Trial focus: The study aims to determine the safety and effectiveness of CD19-CAR_Lenti treatment. It monitors how well the therapy works in achieving complete remission and tracks minimal residual disease at specific intervals after infusion. Before receiving the modified cells, patients undergo a conditioning regimen with fludarabine phosphate and cyclophosphamide to prepare the body.

Investigational treatment: CD19-CAR_Lenti uses specially engineered T cells designed to target and destroy cancer cells bearing the CD19 marker. This is combined with preparatory chemotherapy drugs fludarabine and cyclophosphamide.

Study of Pembrolizumab with Hyaluronidase for Patients with Relapsed or Refractory Hodgkin Lymphoma or Primary Mediastinal Large B-cell Lymphoma

This trial studies a new way of administering pembrolizumab, combined with hyaluronidase, through subcutaneous injection rather than intravenous infusion. The study specifically includes patients with primary mediastinal large B-cell lymphoma that has returned or not responded to treatment.

Main inclusion criteria: Patients must have confirmed diagnosis of either classical Hodgkin lymphoma or primary mediastinal B-cell lymphoma with measurable disease. A life expectancy of at least three months is required, along with an ECOG performance status of 0 to 1. Patients with controlled HIV, hepatitis B on antiviral medication, or successfully treated hepatitis C may participate. Both male and female patients are eligible.

Main exclusion criteria: Patients with other cancer types, those with severe allergic reactions to similar treatments, active infections requiring treatment, pregnant or breastfeeding individuals, unstable heart conditions, recent experimental treatments, certain autoimmune diseases, recent major surgery, uncontrolled high blood pressure, and those with substance abuse issues are excluded.

Trial focus: The study evaluates how pembrolizumab is absorbed when given subcutaneously and measures its effectiveness and safety. It monitors drug concentration levels at different treatment cycles and assesses the overall response rate according to Lugano classification criteria.

Investigational treatment: Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells. Hyaluronidase is added to improve absorption when the medication is injected under the skin.

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

This study tests whether adding acalabrutinib to a reduced-dose chemotherapy regimen called R-miniCHOP can improve outcomes for older adults with newly diagnosed diffuse large B-cell lymphoma, including primary mediastinal large B-cell lymphoma.

Main inclusion criteria: Patients must be over 80 years old, or between 60 and 80 years old and not suitable for full-dose R-CHOP treatment. They need confirmed CD20-positive diffuse large B-cell lymphoma diagnosis, including specific subtypes like primary mediastinal lymphoma. Disease must be stage I with a large tumor, or stage II, III, or IV. An ECOG performance status of 0, 1, or 2 is required. Adequate blood counts and organ function are necessary.

Main exclusion criteria: Patients with other lymphoma types, those already treated for diffuse large B-cell lymphoma, younger patients eligible for full-dose treatment, those unable to take the medication due to allergies, pregnant or breastfeeding individuals, and those with severe heart problems or uncontrolled medical conditions are excluded.

Trial focus: The trial compares progression-free survival between patients receiving acalabrutinib with R-miniCHOP versus R-miniCHOP alone. Participants receive treatment in cycles with regular monitoring of health status and disease progression.

Investigational treatment: Acalabrutinib blocks a protein called Bruton’s tyrosine kinase that helps cancer cells grow. It is combined with rituximab and the R-miniCHOP chemotherapy regimen, which includes reduced doses of doxorubicin, cyclophosphamide, 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 trial tests CLIC-1901 CAR T-cell therapy for patients with B-cell cancers that have returned or not responded to treatment, including certain types of aggressive lymphomas.

Main inclusion criteria: Patients must be between 1 and 70 years old with CD19-expressing blood cancers that are relapsed or refractory. A life expectancy of at least 12 weeks is required. Adequate organ function is necessary, including performance scores above 50%, lung function at least 40% of expected with oxygen levels above 90%, heart function above 45%, and acceptable liver and kidney function. Patients must sign consent and agree to effective birth control measures.

Main exclusion criteria: Patients outside the age range, those not meeting the specified cancer types, and individuals from vulnerable populations requiring special protection are excluded.

Trial focus: The study evaluates the safety and feasibility of CLIC-1901 CAR T-cell therapy. Patients undergo leukapheresis to collect white blood cells, which are modified in the laboratory. After preparatory chemotherapy, the engineered cells are infused. Close monitoring follows for response and management of potential side effects like cytokine release syndrome.

Investigational treatment: CLIC-1901 CAR T-cells are engineered from the patient’s own immune cells to recognize and attack cancer cells expressing the CD19 protein. Tocilizumab may be used to manage side effects.

Study of Axicabtagene Ciloleucel for Patients with Relapsed or Refractory Primary Mediastinal B-Cell Lymphoma

This trial specifically focuses on patients with primary mediastinal large B-cell lymphoma that has returned or not responded after first-line treatment, testing axicabtagene ciloleucel CAR T-cell therapy.

Main inclusion criteria: Patients must be over 18 years old with confirmed primary mediastinal B-cell lymphoma diagnosis. The disease must have relapsed or be refractory after adequate first-line therapy including an anti-CD20 antibody and CHOP or CHOP-like chemotherapy. At least 2 weeks must have passed since previous treatment. An ECOG performance status below 2 is required. Patients need at least one measurable lesion on CT scan, suitable veins for leukapheresis, and adequate organ function. Those capable of reproduction must use effective birth control and agree not to drive for 8 weeks after treatment.

Main exclusion criteria: Patients with other cancer types, those without relapsed or refractory primary mediastinal B-cell lymphoma, individuals outside the age range, and those from vulnerable populations are excluded.

Trial focus: The study measures the complete metabolic response rate at 3 months after CAR T-cell infusion using PET-CT or PET-MRI imaging. Patients undergo leukapheresis, conditioning therapy, and then receive the modified cells through infusion.

Investigational treatment: Axicabtagene ciloleucel involves modifying the patient’s T-cells to express a receptor targeting CD19 protein on cancer cells, helping the immune system destroy the lymphoma cells more effectively.

Study of Glofitamab and Obinutuzumab for Patients with Relapsed or Refractory Lymphomas After CAR T-cell Therapy

This trial evaluates glofitamab for patients whose lymphoma, including diffuse large B-cell lymphoma, has returned or not responded even after CAR T-cell therapy.

Main inclusion criteria: Patients must have received anti-CD19 CAR T-cell therapy at least 1 month prior without significant improvement. The relapse must be confirmed by PET-CT scan showing CD20-expressing lymphoma cells. Patients must be at least 18 years old with good general health and measurable disease. No ongoing severe nerve-related side effects from previous CAR T-cell therapy are allowed. Adequate liver, kidney, and blood cell function is required. Negative tests for hepatitis B, C, and HIV are needed. Effective birth control is mandatory during the study.

Main exclusion criteria: Patients who have not received anti-CD19 CAR T-cell therapy, those from vulnerable populations, and individuals not meeting the health and laboratory requirements are excluded.

Trial focus: The study assesses glofitamab’s effectiveness in improving survival rates and managing disease after CAR T-cell therapy failure. Patients receive obinutuzumab as preparation, followed by glofitamab infusions in cycles, with regular monitoring for response and side effects.

Investigational treatment: Glofitamab is a bispecific antibody that targets both CD3 and CD20 proteins, helping immune cells recognize and destroy cancer cells. Obinutuzumab prepares the body for this treatment.

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

This trial tests rapcabtagene autoleucel CAR T-cell therapy, both alone and combined with ibrutinib, for various blood cancers including high-risk large B-cell lymphomas and diffuse large B-cell lymphoma.

Main inclusion criteria: Adults with specific conditions including chronic lymphocytic leukemia, small lymphocytic lymphoma, high-risk large B-cell lymphoma, diffuse large B-cell lymphoma, or acute lymphoblastic leukemia are eligible. For diffuse large B-cell lymphoma patients, the disease must have relapsed or be refractory after at least two treatments. For high-risk large B-cell lymphoma patients, high-risk features must be present at diagnosis, and specific initial treatment requirements and PET scan results must be met. Both male and female patients can participate.

Main exclusion criteria: Patients with other cancer types not specified, those outside designated age ranges, individuals not meeting specific clinical trial group requirements, and those from vulnerable populations are excluded.

Trial focus: The study has two phases: the first determines the appropriate dose and safety of rapcabtagene autoleucel, alone or with ibrutinib; the second evaluates effectiveness in reducing or eliminating cancer. Patients undergo assessment, cell collection, preparation of modified cells, and infusion, with ongoing monitoring.

Investigational treatment: Rapcabtagene autoleucel uses genetically modified patient immune cells to target cancer cells. Ibrutinib is a medication that stops cancer cells from growing and may enhance the CAR T-cell therapy’s effects.

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

This large international trial compares tisagenlecleucel CAR T-cell therapy with standard care treatments for aggressive B-cell non-Hodgkin lymphoma, including primary mediastinal large B-cell lymphoma, that has relapsed or not responded to treatment.

Main inclusion criteria: Patients must be at least 18 years old with confirmed CD20-positive aggressive B-cell non-Hodgkin lymphoma, including several specific subtypes. The disease must have relapsed or progressed within 365 days after last treatment or not fully responded to initial therapy. Patients should be eligible for stem cell transplant and have active, measurable disease on scans. ECOG performance status of 0 or 1 is required, indicating full activity or ability to carry out light work. Adequate organ function is necessary for kidneys, liver, blood cells, and lungs.

Main exclusion criteria: Patients with different cancer types, those without disease relapse or progression, non-adults, individuals with serious health conditions that could interfere, pregnant or breastfeeding women, those with recent certain treatments, allergies to study medication, or participation in another trial simultaneously are excluded.

Trial focus: The study compares tisagenlecleucel’s effectiveness with standard care in delaying disease progression and improving survival. Participants receive either the CAR T-cell therapy or standard treatments, which may include various chemotherapy combinations. Regular assessments monitor health and treatment response through the trial period extending to 2026.

Investigational treatment: Tisagenlecleucel uses the patient’s own immune cells, collected, modified in a laboratory to better recognize cancer cells, and infused back. This is compared to standard chemotherapy and immunotherapy combinations typically used for aggressive lymphomas.

Summary

The eight ongoing clinical trials for primary mediastinal large B-cell lymphoma demonstrate a strong focus on innovative immunotherapy approaches, particularly CAR T-cell therapies. Five of the trials investigate different CAR T-cell products, reflecting this treatment modality’s prominence in current research for relapsed or refractory disease.

Geographically, the trials are concentrated in Western Europe, with Germany participating in five studies, followed by multiple trials in France, Italy, Spain, and Austria. This distribution suggests these countries have established infrastructure and expertise in conducting complex cellular therapy trials.

The trials address different patient populations: some focus exclusively on relapsed or refractory disease after previous treatments, while others include newly diagnosed high-risk patients or those who have failed CAR T-cell therapy. This variety provides potential trial options for patients at different stages of their treatment journey.

Several trials combine investigational treatments with established therapies. For example, some studies pair CAR T-cells with medications like ibrutinib, or test immune checkpoint inhibitors like pembrolizumab in new administration forms. The age ranges vary significantly, from pediatric patients as young as one year to adults over 80, ensuring research addresses needs across all age groups.

Patients interested in participating should discuss these options with their healthcare team to determine which trial might be most appropriate based on their specific situation, treatment history, and location.

Ongoing Clinical Trials on Primary mediastinal large B-cell lymphoma

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

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study of Axicabtagene Ciloleucel for Patients with Relapsed or Refractory Primary Mediastinal B-Cell Lymphoma

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • 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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