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Follicular lymphoma – Trials in Disease

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Ongoing Clinical Trials for Follicular Lymphoma

Currently, 29 clinical trials are investigating new treatments for follicular lymphoma, a slow-growing blood cancer affecting the lymphatic system. These studies are testing various therapeutic approaches including immunotherapy, targeted therapies, CAR T-cell therapy, and combination treatments for patients whose disease has returned or not responded to previous treatments, as well as newly diagnosed patients. Trials are being conducted across multiple European countries, offering patients access to innovative treatment options.

Clinical trial locations

Trials for relapsed or refractory disease

Study Comparing Golcadomide and Rituximab with Other Treatments for Patients with Relapsed or Refractory Follicular Lymphoma

This trial is testing whether golcadomide combined with rituximab works better than other available treatments chosen by doctors for patients whose disease has returned or has not responded well to previous therapies. The study is open to adults over 18 years with measurable disease and acceptable organ function.

Main inclusion criteria: Patients must be over 18, have relapsed or refractory disease confirmed by specific health criteria, and have adequate laboratory values. Reproductive capacity requirements apply.

Main exclusion criteria: Patients who have received more than two previous treatments, had recent obinutuzumab treatment, have transformed lymphoma, previous CAR-T therapy or golvatinib treatment, recent stem cell transplant, active central nervous system involvement, serious medical conditions, or are pregnant or breastfeeding cannot participate.

Study focus: The trial aims to compare how long participants live without disease progression when receiving golcadomide plus rituximab versus investigator’s choice treatment, and to assess overall survival and quality of life.

Investigational drugs: Golcadomide is an experimental immunomodulatory drug being tested in combination with rituximab, an approved antibody treatment that targets CD20-positive cancer cells.

Study Comparing Odronextamab and Lenalidomide with Rituximab and Lenalidomide for Patients with Relapsed/Refractory Follicular and Marginal Zone Lymphoma

This study compares a new combination of odronextamab and lenalidomide with the established combination of rituximab and lenalidomide. Odronextamab is a bispecific antibody that helps immune cells target cancer cells more effectively.

Main inclusion criteria: Patients must have confirmed CD20-positive disease with measurable lesions, have received at least one previous treatment including anti-CD20 therapy, have adequate blood counts and organ function, and meet specific performance status requirements.

Main exclusion criteria: Patients not meeting age requirements, unable to follow study procedures, or belonging to vulnerable populations are excluded.

Study focus: The trial evaluates progression-free survival comparing the two treatment combinations, with initial safety assessment of odronextamab and lenalidomide.

Investigational drugs: Odronextamab is a bispecific antibody targeting CD20 and CD3, given with lenalidomide, an immunomodulatory agent, versus rituximab (a monoclonal antibody) with lenalidomide.

Study of Mosunetuzumab and Zanubrutinib for Patients with Relapsed or Refractory Follicular Lymphoma

This trial investigates combining mosunetuzumab (a bispecific antibody) with zanubrutinib (a BTK inhibitor) for patients whose disease has not responded to previous treatments. The study includes patients in Italy.

Main inclusion criteria: Patients must provide consent, have adequate blood counts and organ function, be able to swallow capsules, have confirmed diagnosis with measurable disease, and have received one to three previous anti-CD20 antibody-containing treatments.

Main exclusion criteria: Patients with different cancer types, no relapsed/refractory status, outside the specified age range, or from vulnerable populations cannot participate.

Study focus: The trial assesses complete response rate at the end of combination therapy and monitors effectiveness and safety throughout treatment.

Investigational drugs: Mosunetuzumab (subcutaneous bispecific antibody) is combined with zanubrutinib (oral BTK inhibitor) to enhance treatment effectiveness.

Study of Tafasitamab, Lenalidomide, and Rituximab for Patients with Relapsed or Refractory Follicular or Marginal Zone Lymphoma

This large international trial tests whether adding tafasitamab to the combination of lenalidomide and rituximab improves outcomes compared to lenalidomide and rituximab alone.

Main inclusion criteria: Patients must have confirmed CD20-positive disease with measurable lesions, documented relapsed or refractory status after at least one previous treatment including anti-CD20 therapy, and adequate organ function.

Main exclusion criteria: Patients with previous treatment for their current condition, outside the age range, from vulnerable populations, unable to take medications safely, or with certain medical conditions cannot participate.

Study focus: The trial evaluates progression-free survival, comparing the three-drug combination to the two-drug combination, along with overall response rates and safety.

Investigational drugs: Tafasitamab is a monoclonal antibody targeting CD19, given with lenalidomide (immunomodulatory drug) and rituximab (anti-CD20 antibody).

Study Comparing Axicabtagene Ciloleucel with Standard Treatment for Patients with Relapsed or Refractory Follicular Lymphoma

This trial compares CAR T-cell therapy (axicabtagene ciloleucel) with standard chemotherapy treatments for patients whose disease has returned or not responded to previous therapy.

Main inclusion criteria: Patients must have confirmed disease (grade 1, 2, or 3a), relapsed or refractory status after first treatment within 24 months or after at least two previous treatments, need treatment based on current condition, have measurable tumors, and adequate organ function.

Main exclusion criteria: Patients with uncontrolled other cancers, active infections, serious unstable heart, lung, liver or kidney conditions, pregnancy or breastfeeding, recent surgery, or inability to follow study procedures are excluded.

Study focus: The trial measures progression-free survival comparing CAR T-cell therapy to standard treatments, along with overall survival and safety assessments.

Investigational drugs: Axicabtagene ciloleucel is a CAR T-cell therapy using modified immune cells versus standard chemotherapy combinations.

Study on Mosunetuzumab and Lenalidomide for Patients with Follicular Lymphoma After Previous Treatment

This study investigates mosunetuzumab combined with lenalidomide versus rituximab combined with lenalidomide for patients who have had at least one previous treatment.

Main inclusion criteria: Patients must have confirmed CD20-positive disease (grades 1-3a), need systemic therapy, have received at least one previous immunotherapy or chemoimmunotherapy treatment, have tumor samples available, follow lenalidomide risk minimization requirements, and have adequate organ function.

Main exclusion criteria: Patients with different cancer types, no relapsed/refractory status, outside age range, unable to follow procedures, with interfering medical conditions, pregnant or breastfeeding, recent trial participation, or allergies to study medications are excluded.

Study focus: The trial evaluates progression-free survival, overall survival, and response rates comparing the two treatment combinations.

Investigational drugs: Mosunetuzumab (bispecific antibody) with lenalidomide (immunomodulatory drug) versus rituximab (monoclonal antibody) with lenalidomide.

Study of Mosunetuzumab for Patients with Early Relapse of Follicular Lymphoma

This trial studies mosunetuzumab as a second-line treatment for patients whose disease returns or worsens within 24 months after first treatment.

Main inclusion criteria: Patients must provide consent, be at least 18 years old, have confirmed grades 1-3a disease with current relapse or progression within 24 months of starting first treatment, have measurable lesions, and meet WHO performance status requirements.

Main exclusion criteria: Patients with different cancer types, no relapse within 24 months, unsuitable for tested treatment, unable to follow procedures, certain interfering medical conditions, pregnant or breastfeeding, recent trial participation, or severe allergic reactions to similar medications are excluded.

Study focus: The trial assesses progression-free survival, complete and overall response rates, and safety of mosunetuzumab as second-line treatment.

Investigational drugs: Mosunetuzumab is a bispecific antibody administered subcutaneously that helps the immune system target cancer cells.

Study on Rituximab and Lenalidomide for Patients with Relapsed or Refractory Follicular Lymphoma Not Eligible for Transplant

This Italian trial compares maintenance therapy with rituximab and lenalidomide versus rituximab alone for patients not eligible for stem cell transplantation.

Main inclusion criteria: Patients must have grades I, II, or IIIa disease, agree to follow study rules, have adequate blood counts and kidney function, use contraception, have first or second relapse after R-chemotherapy, be over 18, not be eligible for high-dose chemotherapy and transplant, have stage II-IV disease at relapse, need treatment based on specific guidelines, and meet performance status requirements.

Main exclusion criteria: Patients without response to initial treatment, outside specified age range, from vulnerable populations, or not meeting health criteria are excluded.

Study focus: The trial evaluates progression-free survival comparing the two maintenance therapy approaches after initial treatment response.

Investigational drugs: Rituximab (monoclonal antibody) is combined with lenalidomide (immunomodulatory drug) versus rituximab alone as maintenance therapy.

Study on the Effectiveness and Safety of Tisagenlecleucel for Adults with Hard-to-Treat or Returning Follicular Lymphoma

This international trial studies tisagenlecleucel, a CAR T-cell therapy, for adults whose disease has not responded to or has returned after previous treatments.

Main inclusion criteria: Patients must provide consent, be at least 18 years old, have confirmed disease with measurable lesions, meet specific relapse/refraction criteria, have good performance status, adequate laboratory values, lung function, and suitable leukapheresis product.

Main exclusion criteria: Patients with different cancer types, no relapsed/refractory status, under 18, unable to consent, pregnant or breastfeeding, with serious health conditions, recent treatments, allergies to study medication, or recent trial participation are excluded.

Study focus: The trial evaluates complete response rate, overall response rate, progression-free survival, and safety of tisagenlecleucel therapy.

Investigational drugs: Tisagenlecleucel is a CAR T-cell therapy using modified patient immune cells to target cancer cells.

Study of Axicabtagene Ciloleucel for Patients with Relapsed or Refractory Indolent Non-Hodgkin Lymphoma

This French trial investigates axicabtagene ciloleucel CAR T-cell therapy for patients with various indolent lymphomas including follicular lymphoma whose disease has returned or not responded to previous treatments.

Main inclusion criteria: Patients must be 18 or older, have confirmed disease with worsening after at least two treatments including R-bendamustine or R-CHOP, measurable disease, no central nervous system involvement, ability to stop certain therapies before treatment, good performance status, adequate organ function, agreement to use contraception, and negative pregnancy test for females.

Main exclusion criteria: Patients with other cancer types, no relapsed/refractory status, outside age range, unable to consent, pregnant or breastfeeding, certain medical conditions, recent treatments, or allergies to study medications are excluded.

Study focus: The trial evaluates the effectiveness and safety of axicabtagene ciloleucel therapy for relapsed or refractory indolent lymphomas.

Investigational drugs: Axicabtagene ciloleucel is a CAR T-cell therapy using modified patient immune cells to target CD19-positive cancer cells.

Trials for newly diagnosed patients

Study on Early Stage Follicular Lymphoma: Evaluating Radiotherapy with Rituximab or Obinutuzumab for Patients with Early Stage Nodal Follicular Lymphoma

This German trial compares standard-dose radiotherapy with rituximab to low-dose radiotherapy with obinutuzumab for early-stage patients.

Main inclusion criteria: Patients must have CD20-positive grades 1/2 or 3a disease confirmed by central review, use adequate contraception, have untreated disease, be 18 or older, meet performance status requirements, have clinical stage I or II disease, tumors 7 cm or smaller, provide consent, have adequate bone marrow capacity, and understand study requirements.

Main exclusion criteria: Patients with different cancer types, outside age range, unable to give consent, with serious health conditions, pregnant or breastfeeding, having received previous treatments, participating in other trials, or with allergies to study medications cannot participate.

Study focus: The trial evaluates complete response rate at week 18 comparing the two radiotherapy approaches combined with different antibody treatments.

Investigational drugs: Rituximab or obinutuzumab (anti-CD20 antibodies) are combined with either standard-dose or low-dose radiotherapy.

Study on Epcoritamab, Rituximab, and Lenalidomide for Adults with Untreated Follicular Lymphoma

This large international trial tests whether adding epcoritamab to rituximab and lenalidomide improves outcomes for newly diagnosed patients compared to standard chemoimmunotherapy.

Main inclusion criteria: Patients must have confirmed CD20-positive disease with specific stage or tumor size requirements, need treatment based on standard criteria, have measurable lesions, meet performance status requirements, and be eligible for standard treatments.

Main exclusion criteria: Patients who have received previous treatment, outside age range, from vulnerable populations, unable to follow procedures or take medications, or with interfering medical conditions cannot participate.

Study focus: The trial evaluates complete response rate at 30 months comparing the new three-drug combination to standard chemoimmunotherapy.

Investigational drugs: Epcoritamab (bispecific antibody) is combined with rituximab (monoclonal antibody) and lenalidomide (immunomodulatory drug) versus standard chemoimmunotherapy.

Study on Mosunetuzumab and Lenalidomide for Patients with Untreated Follicular Lymphoma

This multicountry trial compares mosunetuzumab and lenalidomide to standard anti-CD20 antibody plus chemotherapy for newly diagnosed patients.

Main inclusion criteria: Patients must have confirmed disease with tissue available for review, adequate blood counts and organ function, need treatment, meet specific prognostic criteria, be at least 18 years old, meet performance status requirements, and have adequate life expectancy.

Main exclusion criteria: Patients who have received previous treatment, with serious health conditions, pregnant or breastfeeding, unable to follow procedures, participating in other trials, with allergies, certain infections, or unable to provide consent are excluded.

Study focus: The trial evaluates progression-free survival comparing mosunetuzumab and lenalidomide to standard treatment with anti-CD20 antibody plus chemotherapy.

Investigational drugs: Mosunetuzumab (bispecific antibody) is combined with lenalidomide (immunomodulatory drug) versus anti-CD20 monoclonal antibody plus chemotherapy.

Summary

The 29 ongoing clinical trials for follicular lymphoma reflect a shift toward targeted immunotherapies and personalized treatment approaches. A notable concentration of trials is taking place in major European countries, with France, Germany, Italy, and Spain hosting the most studies. Interestingly, several trials are being conducted across multiple countries simultaneously, suggesting international collaboration in developing new treatments.

The investigational drugs most frequently studied include mosunetuzumab (appearing in multiple trials), lenalidomide (used in various combinations), rituximab (as both control and active treatment), and newer agents like golcadomide, odronextamab, and epcoritamab. Several trials focus on CAR T-cell therapies such as axicabtagene ciloleucel and tisagenlecleucel, representing the cutting edge of cellular immunotherapy.

The trials address different patient populations: some focus on relapsed or refractory disease (the majority), while others investigate treatments for newly diagnosed patients. Several studies specifically target early-stage disease or patients experiencing early relapse. Most trials include careful exclusion criteria regarding previous treatments, age limits, and organ function requirements to ensure patient safety.

Common themes across trials include combinations of bispecific antibodies with immunomodulatory drugs, comparisons of new regimens against standard chemotherapy, and investigations of maintenance therapy approaches. The studies generally measure progression-free survival as a primary outcome, with secondary endpoints including overall survival, response rates, and quality of life assessments.

Ongoing Clinical Trials on Follicular lymphoma

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

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study of dapagliflozin to prevent heart complications during lymphoma treatment in patients receiving first-line therapy

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study Comparing Golcadomide and Rituximab with Other Treatments for Patients with Relapsed or Refractory Follicular Lymphoma

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland France Germany Greece Italy The Netherlands +2

  • 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 tazemetostat combined with lenalidomide and rituximab in adult patients with relapsed or refractory follicular lymphoma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Hungary Italy Poland +1

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

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on Early Stage Follicular Lymphoma: Evaluating Radiotherapy with Rituximab or Obinutuzumab for Patients with Early Stage Nodal Follicular Lymphoma

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Mosunetuzumab and Lenalidomide for Patients with Untreated Follicular Lymphoma

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium France Germany Portugal Spain

  • Study Comparing Odronextamab and Lenalidomide with Rituximab and Lenalidomide for Patients with Relapsed/Refractory Follicular and Marginal Zone Lymphoma

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia France Germany Italy +2

  • Study on Safe Skin Test Concentrations for Biotherapy Allergies in Patients with Cancer Using Atezolizumab, Daratumumab, and Nivolumab

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

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