#1 Clinical Trials Search in Europe

Mantle cell lymphoma – Trials in Disease

Go back

Ongoing Clinical Trials for Mantle Cell Lymphoma

Mantle cell lymphoma is a rare form of non-Hodgkin lymphoma currently being investigated in 27 clinical trials across Europe. These trials test various treatment combinations including targeted therapies, chemotherapy regimens, immunotherapy approaches, and novel cell-based treatments for both newly diagnosed and relapsed/refractory patients.

Clinical trial locations

Study of Acalabrutinib with R-CHOP for Patients with Untreated Mantle Cell Lymphoma in Spain

This trial is evaluating the combination of acalabrutinib with R-CHOP chemotherapy for patients in Spain who have not received prior treatment for their condition. The study aims to assess how well this treatment combination works in managing previously untreated cases.

Inclusion criteria: Adults aged 18 or older can participate if they have previously untreated disease and are unsuitable for autologous stem cell transplantation. Participants must have confirmed diagnosis with specific genetic markers, measurable disease on imaging tests, and an ECOG performance status of 2 or less. Women of childbearing potential must use highly effective contraception during the study and for a specified period afterward. Men must also use barrier contraception and may consider sperm freezing before starting treatment.

Exclusion criteria: Patients who have received any previous treatment cannot participate. Those with other active cancers, serious heart problems, uncontrolled high blood pressure, active infections requiring treatment, or who are pregnant or breastfeeding are excluded. Patients with known allergies to study drugs, certain blood disorders, recent major surgery, or a history of recent drug or alcohol abuse are also not eligible.

Focus: The study focuses on evaluating acalabrutinib combined with R-CHOP for managing the disease and monitoring response over time. The treatment involves taking acalabrutinib as film-coated tablets along with the R-CHOP chemotherapy regimen, which includes rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.

Investigational drug: Acalabrutinib is a BTK inhibitor that blocks a specific protein in cancer cells to help stop their growth. R-CHOP is a standard chemotherapy combination where each drug works in a unique way to attack cancer cells and reduce their numbers in the body.

Study of Venetoclax, Ibrutinib, and Rituximab or Bendamustine Combination for Patients with Untreated Mantle Cell Lymphoma Not Suitable for High-Dose Therapy

This German and Italian trial is exploring different treatment combinations for patients who have not received prior treatment and are not eligible for high-dose therapy. The study compares venetoclax, ibrutinib, and rituximab with the conventional bendamustine, ibrutinib, and rituximab regimen.

Inclusion criteria: Participants must be at least 60 years old and unsuitable for autologous stem cell transplantation. They must have confirmed diagnosis according to WHO classification, be in Stage II-IV disease, have at least one measurable lesion, and an ECOG performance status of 2 or less. Adequate kidney and liver function is required, with specific laboratory values for neutrophils, platelets, and liver enzymes.

Exclusion criteria: The study excludes patients with other types of cancer, those outside the specified age range, those unable to follow study procedures, pregnant or breastfeeding women, and vulnerable populations.

Focus: The trial evaluates failure-free survival at 30 months by comparing the two treatment combinations. Participants receive either venetoclax plus rituximab and ibrutinib, or bendamustine plus rituximab and ibrutinib, administered through infusion and oral medications.

Investigational drugs: Venetoclax targets a protein that cancer cells need to survive, promoting their death. Ibrutinib is a BTK inhibitor that blocks proteins helping cancer cells grow. Rituximab is a monoclonal antibody targeting CD20 on cancer cells, and bendamustine is chemotherapy that damages cancer cell DNA.

Study of Zanubrutinib and Rituximab Compared to Bendamustine and Rituximab for Patients with Untreated Mantle Cell Lymphoma Ineligible for Stem Cell Transplant

This international trial spanning 11 countries compares zanubrutinib plus rituximab with bendamustine plus rituximab for patients who cannot undergo stem cell transplantation and have not received prior treatment.

Inclusion criteria: Patients must be at least 70 years old, or between 60-69 with specific health issues preventing stem cell treatment. Men must use effective birth control during and after the study. Participants need confirmed diagnosis, no previous treatments except diagnostic splenectomy, measurable disease, adequate organ function, and a life expectancy of at least 3 months.

Exclusion criteria: Patients with other cancer types, those not in the specified age range, vulnerable populations, those unable to follow procedures, pregnant or breastfeeding women, and those with serious interfering health conditions or recent trial participation are excluded.

Focus: The study evaluates progression-free survival by comparing the two treatment combinations administered through infusions and monitoring patient response over time.

Investigational drugs: Zanubrutinib blocks BTK proteins that cancer cells need to grow. Rituximab targets CD20 proteins on cancer cells, helping the immune system destroy them. Bendamustine is chemotherapy that damages cancer cell DNA to stop their growth.

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 Danish trial tests CLIC-1901 CAR T-cell therapy combined with tocilizumab for patients whose cancer has returned or not responded to previous treatments, including some with mantle cell lymphoma.

Inclusion criteria: Patients aged 1-70 years with relapsed or refractory CD19-expressing blood cancers can participate. They need adequate organ function (including lung, heart, liver, and kidney function above specified thresholds), life expectancy of at least 12 weeks, and ECOG performance status above 50%.

Exclusion criteria: Patients with cancer that has not returned or worsened, those outside the age range, and vulnerable populations are excluded.

Focus: The study assesses the safety and feasibility of CLIC-1901 CAR T-cells, which are engineered immune cells designed to recognize and attack cancer cells expressing CD19 protein. The treatment is administered through intravenous infusion following a leukapheresis procedure to collect immune cells.

Investigational drug: CLIC-1901 CAR T-cells are modified immune cells targeting CD19-expressing cancer cells. This cell-based immunotherapy is being evaluated for safety in treating relapsed or refractory blood cancers.

Study on Glofitamab, Venetoclax, and Zanubrutinib for Patients with Untreated or Relapsed High-Risk Mantle Cell Lymphoma

This French and Belgian trial tests combinations of glofitamab, venetoclax, and zanubrutinib for patients with high-risk disease who are either newly diagnosed or have relapsed/refractory disease.

Inclusion criteria: Adults aged 18-79 with confirmed high-risk diagnosis, measurable disease on imaging, Stage II-IV disease, ECOG performance status of 0-2, life expectancy over 3 months, and adequate organ function can participate. Women of childbearing potential and men capable of fathering children must use contraception during and after the study.

Exclusion criteria: Patients unwilling or unable to follow procedures, those with serious interfering health conditions, pregnant or breastfeeding women, recent trial participants, those with drug allergies, and those with certain infections are excluded.

Focus: The study evaluates progression-free survival at 12 months using different combinations of the three medications. Glofitamab is administered intravenously, while venetoclax and zanubrutinib are taken orally.

Investigational drugs: Glofitamab is a bispecific monoclonal antibody targeting proteins on cancer cells. Venetoclax inhibits a protein helping cancer cells survive, leading to their death. Zanubrutinib blocks BTK protein involved in cancer cell growth.

Study on Golcadomide and Valemetostat Tosylate for Patients with Relapsed or Refractory Non-Hodgkin Lymphomas

This trial in Denmark, France, Spain, and Italy evaluates golcadomide (CC-99282) alone or combined with other drugs for various types of non-Hodgkin lymphomas, including mantle cell lymphoma, that have relapsed or not responded to treatment.

Inclusion criteria: Adults 18 or older with relapsed/refractory disease after at least one prior treatment, ECOG performance status of 0-2, and specific blood count and organ function thresholds can participate. Participants must agree to pregnancy prevention measures.

Exclusion criteria: Patients with other cancer types, serious interfering health conditions, pregnant or breastfeeding women, those with recent heart problems, active infections, known allergies, concurrent trial participation, substance abuse history, mental health conditions affecting participation, recent surgery, certain recent treatments, or known infections (HIV, hepatitis) are excluded.

Focus: The study assesses safety, tolerability, and optimal dosing of golcadomide alone and in combination with rituximab, obinutuzumab, tafasitamab, or valemetostat.

Investigational drugs: Golcadomide (CC-99282) is an experimental small molecule being tested for safety and effectiveness. Rituximab, obinutuzumab, and tafasitamab target specific proteins on cancer cells to help the immune system fight them. Valemetostat is investigational and may be used with rituximab.

Study on Ibrutinib, CD20 Ab and Venetoclax for Patients with Untreated Mantle Cell Lymphoma

This French and Belgian trial evaluates combination therapies using ibrutinib plus CD20 antibodies (rituximab or obinutuzumab) with or without venetoclax for previously untreated patients.

Inclusion criteria: Patients aged 18-79 with Stage II-IV disease requiring treatment, ECOG performance status of 0-2, at least one measurable lesion, life expectancy over 3 months, confirmed diagnosis, no previous treatment, and adequate organ function can participate. Sexually active individuals must use effective contraception.

Exclusion criteria: Patients with other cancer types, those outside the age range, vulnerable populations, and those unable to follow procedures are excluded.

Focus: The study measures minimum residual disease rates at the end of 6 treatment cycles using droplet digital PCR. Treatment includes oral ibrutinib and venetoclax with intravenous rituximab.

Investigational drugs: Ibrutinib blocks BTK proteins helping cancer cells grow. CD20 antibodies (rituximab/obinutuzumab) target proteins on cancer cells to help the immune system destroy them. Venetoclax targets proteins preventing cancer cell death.

Study on KTE-X19 CAR-T Cell Therapy for Patients with Relapsed or Refractory Mantle Cell Lymphoma Responding Partially to Ibrutinib

This Italian trial tests KTE-X19 CAR T-cell therapy for patients whose disease has returned or not fully responded and who show partial response to ibrutinib treatment.

Inclusion criteria: Patients aged 18-75 with confirmed diagnosis, relapsed/refractory disease after at least one prior treatment, currently receiving ibrutinib without tolerability issues, partial response confirmed by imaging after at least 6 months of ibrutinib, adequate blood counts and organ function, life expectancy of at least 12 weeks, and available tumor samples can participate. Women and men must use effective contraception.

Exclusion criteria: Patients without relapsed/refractory disease, not receiving ibrutinib monotherapy, not in partial remission during ibrutinib therapy, unable to receive KTE-X19 infusion, or outside the specified age range are excluded.

Focus: The study evaluates the effectiveness of KTE-X19 CAR T-cell therapy following ibrutinib treatment. Patients first receive ibrutinib, then undergo lymphodepletion chemotherapy with cyclophosphamide and fludarabine before receiving the CAR T-cell infusion.

Investigational drugs: KTE-X19 uses a patient’s own immune cells modified to better attack cancer cells. Ibrutinib helps slow cancer growth by blocking specific proteins and is used to achieve partial response before CAR T-cell therapy.

Study on the Effectiveness and Safety of Pirtobrutinib and Rituximab for Untreated Adult Patients with Indolent Mantle Cell Lymphoma

This Spanish and Portuguese trial evaluates pirtobrutinib combined with rituximab for adults with indolent (slow-growing) disease who have not yet received treatment.

Inclusion criteria: Adults 18 or older with stable disease for at least 3 months, confirmed diagnosis, no prior treatment except diagnostic splenectomy, no disease symptoms, ECOG performance status less than 2, adequate organ function, and specific laboratory values can participate. Women and men must use effective birth control.

Exclusion criteria: Patients who have received prior treatment, those with non-indolent disease forms, and vulnerable populations are excluded.

Focus: The study assesses complete remission rates by the end of Cycle 6. Pirtobrutinib is administered orally as film-coated tablets, and rituximab is given through intravenous infusion.

Investigational drugs: Pirtobrutinib blocks proteins helping cancer cells grow and survive. Rituximab is a monoclonal antibody targeting CD20 proteins on cancer cells, helping the immune system destroy them.

Study on the Effectiveness and Safety of Sonrotoclax and Zanubrutinib for Adults with Relapsed or Refractory Mantle Cell Lymphoma

This trial across Poland, Italy, Austria, Germany, Spain, and France compares sonrotoclax plus zanubrutinib against placebo plus zanubrutinib for adults with relapsed or refractory disease.

Inclusion criteria: Adults with confirmed diagnosis who have received 1-5 previous treatments including anti-CD20 therapy, whose disease has returned or not responded to the last treatment, with measurable disease on imaging, ECOG performance status of 0-2, and adequate organ function can participate.

Exclusion criteria: Patients without relapsed/refractory disease, those outside the age range, those unwilling to follow procedures, with serious interfering health conditions, pregnant or breastfeeding women, recent trial participants, those with drug allergies, and those with certain infections are excluded.

Focus: The study evaluates progression-free survival. Participants are randomly assigned to receive either sonrotoclax plus zanubrutinib or placebo plus zanubrutinib, taken orally, with regular monitoring and quality of life assessments.

Investigational drugs: Sonrotoclax targets proteins helping cancer cells survive, leading to their death. Zanubrutinib blocks BTK proteins that cancer cells need to grow, slowing or stopping disease progression.

Study on the Safety and Effectiveness of AZD0486 Alone or with Other Drugs for Adults with Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, or Large B-Cell Lymphoma

This multi-country trial (Denmark, Czechia, France, Germany, Spain) evaluates AZD0486 alone or combined with other anticancer drugs for various blood cancers including mantle cell lymphoma.

Inclusion criteria: Adults over 18 with specific diagnoses, Stage II-IV disease, at least one measurable site, ECOG performance status of 0-2, adequate blood counts, kidney and liver function, life expectancy over 3 months, and confirmed CD19 expression if previously treated with anti-CD19 therapy can participate. Different cohorts have specific prior treatment requirements.

Exclusion criteria: Patients with conditions other than the specified cancers, those outside the age range, and vulnerable populations are excluded.

Focus: The study assesses safety and optimal dosing of AZD0486 as monotherapy and in combination with other treatments through intravenous or subcutaneous administration.

Investigational drug: AZD0486 is an anticancer agent being evaluated for safety and effectiveness in treating mature B-cell malignancies by targeting specific pathways involved in cancer cell growth.

Summary

The 27 ongoing trials for mantle cell lymphoma reflect a diverse and comprehensive research effort across Europe. A notable concentration of trials is evident in France, Spain, Italy, and Germany, which together host the majority of studies. This geographical distribution suggests these countries have well-established research infrastructure for hematological malignancies.

The trials demonstrate a clear focus on several therapeutic approaches. BTK inhibitors feature prominently, with multiple studies evaluating acalabrutinib, ibrutinib, zanubrutinib, and pirtobrutinib either as monotherapy or in combination regimens. Venetoclax, a BCL-2 inhibitor, appears in several combination protocols, reflecting growing interest in this mechanism of action. CAR T-cell therapies represent an emerging treatment modality, with at least three trials investigating different cellular immunotherapy approaches.

Many trials specifically address treatment for patients ineligible for stem cell transplantation or high-dose therapy, acknowledging that a significant proportion of patients are elderly or have comorbidities. Several studies also focus on relapsed or refractory disease, recognizing the need for effective salvage therapies.

The research landscape includes both phase II and phase III studies, with some comparing novel combinations against standard-of-care regimens. This mix suggests the field is both exploring new treatment paradigms and seeking to validate promising approaches through comparative trials.

Ongoing Clinical Trials on Mantle cell lymphoma

  • Study on Obinutuzumab, Venetoclax, and Ibrutinib for Patients with Relapsed or Refractory Mantle Cell Lymphoma

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

More information about
Mantle cell lymphoma:

Connected medications: