Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

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

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called Mantle Cell Lymphoma, which is a rare form of non-Hodgkin's lymphoma. The study is exploring the effectiveness of different treatment combinations for patients who have not received prior treatment and are not eligible for high-dose therapy. The treatments being tested include a combination of medications: Venetoclax (also known by its code name ABT-199), Ibrutinib, and Rituximab, as well as a conventional chemotherapy regimen that includes Bendamustine, Ibrutinib, and Rituximab. Venetoclax and Ibrutinib are taken orally, while Bendamustine and Rituximab are administered through intravenous infusion, which means they are given directly into a vein.

The purpose of the study is to evaluate how well these treatment combinations work in terms of failure-free survival, which refers to the length of time during and after treatment that a patient lives with the disease without it getting worse. The study will follow participants over a period of time to see how long they remain free from disease progression. Participants will receive one of the treatment combinations and will be monitored regularly to assess their response to the treatment and any side effects they may experience. The study aims to provide valuable information on the effectiveness and safety of these treatment options for patients with Mantle Cell Lymphoma.

Throughout the study, researchers will also look at other important outcomes, such as progression-free survival, which is the time during and after treatment that a patient lives without the disease worsening, and overall survival, which is the time a patient lives from the start of the study. Additionally, the study will assess the quality of life of participants during the treatment period. This research is important for understanding how these treatments can help manage Mantle Cell Lymphoma and improve the lives of those affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of mantle cell lymphoma and ensuring other health criteria are met.

  2. Step 2

    Treatment allocation

    Participants are assigned to one of two treatment groups. One group receives a combination of venetoclax, ibrutinib, and rituximab. The other group receives bendamustine, ibrutinib, and rituximab.

  3. Step 3

    Medication administration

    For the group receiving venetoclax, the medication is taken orally in the form of film-coated tablets. Ibrutinib is administered as hard capsules taken orally. Rituximab is given through an intravenous infusion.

    For the group receiving bendamustine, the medication is administered via intravenous infusion. Ibrutinib and rituximab are administered in the same manner as the other group.

  4. Step 4

    Treatment duration

    The treatment is conducted over a specified period, with regular monitoring to assess the effectiveness and safety of the medications. The primary goal is to evaluate failure-free survival at 30 months.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, participants undergo regular health assessments to monitor progress and any side effects. This includes evaluating overall survival, response rates, and quality of life.

  6. Step 6

    Completion of trial

    The trial is expected to conclude by September 2028. Final assessments will be conducted to determine the long-term efficacy and safety of the treatments.

Who can join the trial?

12 criteria

  • Must have a confirmed diagnosis of Mantle Cell Lymphoma (MCL) according to the World Health Organization (WHO) classification.
  • Creatinine level must be less than or equal to 2 mg/dL, or estimated Glomerular Filtration Rate (eGFR) must be at least 50 mL/min. Creatinine and eGFR are measures of kidney function.
  • Must provide a written informed consent form, which is a document that explains the study and confirms your agreement to participate.
  • Sexually active men with female partners who can become pregnant must agree to use highly effective birth control methods.
  • Must not have received previous treatment for MCL and be in stage II-IV according to the Ann Arbor staging system, which describes the extent of cancer spread.
  • Must be at least 60 years old and not suitable for a procedure called autologous stem cell transplant (SCT).
  • Must have at least one measurable lesion, which is an area of cancer that can be measured. If the cancer is only in the bone marrow, a bone marrow aspiration and biopsy are required for all evaluations.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. This is a scale that measures how well you can perform daily activities.
  • Must have an absolute neutrophil count (ANC) of at least 1000 cells per microliter. Neutrophils are a type of white blood cell important for fighting infections.
  • Must have a platelet count of at least 75,000 cells per microliter. Platelets are cells that help with blood clotting.
  • Must have transaminase levels (AST and ALT) that are no more than 3 times the upper limit of normal (ULN). AST and ALT are enzymes that indicate liver function.
  • Total bilirubin must be no more than 2 times the ULN unless there is another known reason, such as Gilbert-Meulengracht Syndrome, which is a common and harmless liver condition.

Who cannot join the trial?

6 criteria

  • Patients with other types of cancer besides Mantle Cell Lymphoma cannot participate. Mantle Cell Lymphoma is a specific type of cancer that affects the lymph nodes.
  • Patients who have not failed previous treatments for Mantle Cell Lymphoma are excluded. This means the study is for those whose previous treatments did not work.
  • Patients who are under 18 years old or over 65 years old cannot join the study. The study is only for adults within this age range.
  • Patients who are pregnant or breastfeeding are not allowed to participate. This is to ensure the safety of both the mother and the baby.
  • Patients with serious health conditions that could interfere with the study are excluded. This includes conditions that might make it unsafe for them to participate.
  • Patients who are unable to follow the study procedures or attend regular check-ups are not eligible. This is important for the accuracy and safety of the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Venetoclax

    is a medication used to help treat certain types of blood cancers. It works by targeting and blocking a specific protein that cancer cells need to survive, which can help to kill the cancer cells and slow down the progression of the disease.

  • Ibrutinib

    is a type of medication known as a BTK inhibitor. It is used to treat certain blood cancers by blocking a protein that helps cancer cells grow and divide. This can help to stop the spread of cancer and reduce symptoms.

  • Rituximab

    is a medication that targets specific cells in the immune system. It is used to treat certain types of blood cancers by helping the immune system to destroy cancer cells. It can also help to reduce the size of tumors and slow the progression of the disease.

  • Bendamustine

    is a type of chemotherapy used to treat certain types of blood cancers. It works by damaging the DNA of cancer cells, which can prevent them from growing and dividing. This can help to reduce the number of cancer cells in the body and slow the progression of the disease.

What is already known about the treatment

  • Venetoclax

    Venetoclax is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating Mantle Cell Lymphoma, particularly in combination with other medications. The main therapeutic indication for Venetoclax is its use in certain types of blood cancers. It works by inhibiting a protein called BCL-2, which helps cancer cells survive, thereby promoting their death. Venetoclax is classified as a BCL-2 inhibitor.

  • Ibrutinib

    Ibrutinib is taken orally as a capsule or tablet. It is widely used in the treatment of various blood cancers, including Mantle Cell Lymphoma, and is being evaluated in combination therapies. Its primary therapeutic use is to treat certain types of lymphoma and leukemia. Ibrutinib functions by blocking a protein called Bruton's tyrosine kinase (BTK), which is involved in the growth and survival of cancer cells. It belongs to the class of medications known as BTK inhibitors.

  • Rituximab

    Rituximab is administered through intravenous infusion. It is a well-established medication in the treatment of certain types of blood cancers, including Mantle Cell Lymphoma. Rituximab is primarily used to target and destroy specific cancer cells. It works by binding to a protein called CD20 found on the surface of certain cancer cells, marking them for destruction by the immune system. Rituximab is classified as a monoclonal antibody.

  • Bendamustine

    Bendamustine is given by intravenous infusion. It is an established treatment option for certain types of blood cancers, including Mantle Cell Lymphoma, and is being studied in combination with other drugs. The main therapeutic indication for Bendamustine is its use in treating lymphomas and leukemias. It works by damaging the DNA in cancer cells, which prevents them from dividing and leads to cell death. Bendamustine is classified as an alkylating agent.

Investigated diseases

Mantle Cell Lymphoma – Mantle Cell Lymphoma is a type of non-Hodgkin lymphoma that originates from B-cells, which are a type of white blood cell. It typically begins in the outer edge of a lymph node called the mantle zone. The disease often progresses by spreading to other lymph nodes, bone marrow, and sometimes the spleen or gastrointestinal tract. Patients may experience symptoms such as swollen lymph nodes, fatigue, fever, night sweats, and weight loss. The progression of Mantle Cell Lymphoma can vary, with some cases advancing more rapidly than others. It is considered a challenging condition due to its tendency to be diagnosed at an advanced stage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501808-96-00Protocol code20-01434Estimated enrolment235 patientsSponsorUniversitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.