Ongoing Clinical Trials for Recurrent Non-Hodgkin’s Lymphoma
There are currently 3 clinical trials investigating new treatments for recurrent non-Hodgkin’s lymphoma across Europe. These studies are exploring novel therapies including targeted medications, immunotherapy combinations, and CAR T-cell therapy for patients whose cancer has returned or has not responded to previous treatments.
Clinical trial locations
- France
- Germany
- Netherlands
- Poland
- Spain
- Study of MEN1703 and Glofitamab for Patients with Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma
- Study on Axicabtagene Ciloleucel for Patients with Late Relapse of Diffuse Large B-Cell Lymphoma
- Study on BMS-986458 and Rituximab for Patients with Relapsed or Refractory Non-Hodgkin Lymphoma
Study of MEN1703 and Glofitamab for Patients with Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma
This trial is investigating the combination of MEN1703 and Glofitamab for patients with aggressive B-cell lymphoma that has returned or not responded to previous treatments. MEN1703 is available as a capsule, while Glofitamab is given through an infusion directly into the bloodstream.
Who can participate:
- Adults aged 18 years or older with a life expectancy of at least 12 weeks
- Patients with confirmed aggressive B-cell lymphoma, including diffuse large B-cell lymphoma or transformed indolent B-cell lymphoma
- Those who have received at least 2 prior treatment courses
- Patients with at least one measurable site of disease visible on CT or PET-CT scans
- Adequate organ function, including liver, kidney, and heart function
- Normal blood cell counts, including lymphocyte count less than 5.0 x 10⁹/L, platelet count at least 75 x 10⁹/L, and hemoglobin at least 10.0 g/dL
Who cannot participate:
- Patients with other types of cancer not being studied
- Those with recent heart attack or severe heart problems
- Patients with uncontrolled infections
- Pregnant or breastfeeding women
- Patients who have had an organ transplant
- Those with severe liver or kidney disease
- Patients with a history of severe allergic reactions to similar medications
Study focus: The trial aims to evaluate how safe and well-tolerated MEN1703 is, both alone and in combination with Glofitamab. Researchers will monitor patients closely to assess how effectively these treatments fight the lymphoma, tracking any side effects and measuring the response of the cancer to treatment. The study is expected to continue until the end of 2026.
Study on Axicabtagene Ciloleucel for Patients with Late Relapse of Diffuse Large B-Cell Lymphoma
This trial is studying Axicabtagene Ciloleucel, a type of CAR T-cell therapy that uses a patient’s own modified immune cells to fight cancer. The study focuses specifically on patients whose diffuse large B-cell lymphoma returned between one and five years after their initial treatment.
Who can participate:
- Adults over 18 years old who can speak one of their country’s official languages
- Patients with confirmed aggressive B-cell lymphoma, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, or follicular lymphoma Grade 3B
- Those who experienced disease relapse between 12 months and 5 years after completing first-line treatment with anti-CD20 antibody and CHOP chemotherapy
- Positive result on PET imaging
- Performance status score of 0, 1, or 2
- Adequate blood counts, kidney function (creatinine clearance at least 50 mL/min), liver function, and heart function (cardiac ejection fraction at least 45%)
- Baseline oxygen level of at least 92% on room air
Who cannot participate:
- Patients who have not experienced a late relapse (between 1 and 5 years after first treatment)
- Those not diagnosed with diffuse large B-cell lymphoma
- Patients outside the specified age range
- Members of vulnerable populations requiring special protection
Study focus: The trial will evaluate how well Axicabtagene Ciloleucel works for patients with late relapse. Before receiving the CAR T-cell therapy, patients will undergo a procedure called leukapheresis to collect their white blood cells, which are then modified in a laboratory. Patients also receive preparatory chemotherapy with Cyclophosphamide and Fludarabine before the CAR T-cell infusion. The study will track response rates, duration of response, and monitor for any side effects. The trial is expected to continue until 2031.
Study on BMS-986458 and Rituximab for Patients with Relapsed or Refractory Non-Hodgkin Lymphoma
This trial is testing a new treatment called BMS-986458, both alone and in combination with Rituximab, for patients whose lymphoma has returned or not responded to previous treatments. BMS-986458 is taken as a tablet, while Rituximab is given as an infusion into the bloodstream.
Who can participate:
- Adults aged 18 years or older
- Patients with relapsed or refractory non-Hodgkin lymphoma, including diffuse large B-cell lymphoma and follicular lymphoma
- For those with diffuse large B-cell lymphoma or follicular lymphoma Grade 3b: at least two previous treatments including rituximab, anthracycline, an alkylating agent, and steroids
- For transformed lymphoma: at least two previous treatments after the lymphoma changed form
- For follicular lymphoma (except Grade 3b): at least two previous treatments
- Measurable disease with at least one area larger than 1.5 cm visible on CT or MRI scans
- Agreement to follow a pregnancy prevention plan
Who cannot participate:
- Patients with a different type of cancer other than non-Hodgkin lymphoma
- Pregnant or breastfeeding women
- Those unable to follow study procedures or take medication as required
- Patients with certain medical conditions that might interfere with the study or make it unsafe
- Those currently participating in or recently participated in another clinical trial
- Patients who have had recent major surgery or have a serious infection
- Those with a history of allergic reactions to the study medication
Study focus: The trial aims to determine how safe and tolerable BMS-986458 is, establish the best dose to use, and evaluate its effectiveness both alone and with other anti-lymphoma medications. Researchers will monitor patients for any adverse effects and track how well the treatment works by measuring response rates and how long patients remain progression-free. The study is expected to conclude by October 2028.
Summary
These three clinical trials represent important research efforts to find better treatments for recurrent non-Hodgkin’s lymphoma across Europe. The trials are geographically concentrated in Spain, which hosts all three studies, while France, Germany, Netherlands, and Poland participate in one or two trials each.
The studies explore diverse therapeutic approaches. One trial tests a novel combination therapy with MEN1703 and Glofitamab, another investigates CAR T-cell therapy with Axicabtagene Ciloleucel specifically for late relapses, and a third examines the experimental medication BMS-986458 alone or with Rituximab. Each trial targets slightly different patient populations, with varying requirements for previous treatments and disease characteristics.
Patients interested in participating should discuss these options with their healthcare providers to determine which trial, if any, might be suitable for their specific situation. All trials include careful monitoring for safety and effectiveness throughout the treatment period.