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Study on Copanlisib and Rituximab for Patients with Marginal Zone Lymphoma Needing Treatment After Local Therapy Failure or Relapse

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the treatment of Marginal Zone Lymphoma (MZL), a type of cancer that affects the lymphatic system. The study will use two medications: Copanlisib and Rituximab. Copanlisib is a medication that helps to block certain proteins that cancer cells need to grow, while Rituximab is a type of protein that targets and helps destroy cancer cells. The purpose of the study is to test how effective and safe these medications are when used together in patients who need treatment for MZL, especially those who have not responded to or are not eligible for local treatments like surgery or radiotherapy.

Participants in the study will receive the medications through an intravenous infusion, which means the drugs are given directly into a vein. The study will last for about 12 months, during which the response to the treatment will be closely monitored. This includes checking for complete remission, which means the disappearance of all signs of cancer in response to treatment. The study will also document any side effects and how the treatment affects the quality of life of the participants. The goal is to understand how well the combination of Copanlisib and Rituximab works in treating MZL and to identify any potential risks associated with the treatment.

Throughout the study, participants will have regular visits for drug administration, imaging studies like MRI or CT scans, and laboratory tests to monitor their health and the progress of the treatment. The study will also track the time it takes for the best response to occur, how long the response lasts, and the overall survival of the participants. This information will help researchers determine the effectiveness of the treatment and its impact on the participants' lives.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria related to the type of lymphoma and other health parameters.

    Informed consent is required, indicating awareness of the study's nature, procedures, and potential risks.

  2. Step 2

    Induction therapy

    The induction phase involves receiving two medications: rituximab and copanlisib.

    Rituximab is administered as an intravenous infusion. The specific dosage and frequency are determined by the healthcare provider.

    Copanlisib is also given as an intravenous infusion. The dosage and schedule are tailored to individual needs.

  3. Step 3

    Maintenance therapy

    Following the induction phase, maintenance therapy continues with rituximab.

    The frequency and duration of this phase depend on the response to the initial treatment and are monitored by the healthcare team.

  4. Step 4

    Monitoring and assessments

    Regular assessments are conducted to evaluate the response to treatment, including imaging studies and laboratory tests.

    Quality of life is assessed periodically using a specific questionnaire designed for lymphoma patients.

  5. Step 5

    End of study

    The study concludes with a final evaluation of treatment response and any long-term effects.

    Participants are informed of the study's outcomes and any further steps if necessary.

Who can join the trial?

20 criteria

  • Must have a confirmed diagnosis of **CD20 positive Marginal Zone Lymphoma (MZL)**, which is a type of cancer affecting the lymphatic system.
  • Must be at least **18 years old**.
  • Must have a **life expectancy of more than 3 months**.
  • Must have a **baseline platelet count** of at least 50 G/L, unless the low count is due to the lymphoma affecting the bone marrow.
  • Must have an **absolute neutrophil count** of at least 0.75 G/L. Neutrophils are a type of white blood cell important for fighting infections.
  • Must have **ASAT (SGOT)** and **ALAT (SGPT)** levels that are no more than 3 times the normal value. These are liver enzymes that help assess liver function.
  • Must have a **total bilirubin** level of no more than 2 mg/dL or 2 times the normal value, unless related to the disease. Bilirubin is a substance made during the breakdown of red blood cells.
  • Must have a **glomerular filtration rate (GFR)** of at least 40 mL/min/1.73 m², which measures kidney function.
  • Must test **negative for HIV antibodies**.
  • Must have **positive test results for chronic Hepatitis B Virus (HBV) infection** but with undetectable HBV DNA if there was a past infection.
  • Must have **positive test results for Hepatitis C** but with a negative PCR test for HCV RNA.
  • For women of child-bearing potential, must have a **negative pregnancy test** and agree to use effective birth control during and after the study.
  • Men must agree not to father a child during and for 6 months after the study and advise their partner to use effective birth control.
  • Must be willing and able to **comply with study visits, drug administration, and other procedures**.
  • Must have **signed informed consent**, indicating understanding of the disease, study procedures, and potential risks and benefits.
  • Must have had **tissue diagnostic procedures** within 12 months before the study, confirmed by a pathology center.
  • Must be in need of treatment for **symptomatic MZL** that is new or has returned after local therapy.
  • For nodal MZL and extranodal MZL, must have at least one **measurable lesion** of at least 1.5 cm by CT or MRI.
  • For splenic MZL, must have an **enlarged spleen** and lymphoma cell presence in bone marrow or blood, with specific symptoms or conditions.
  • For gastric MALT lymphoma, must have **clinical evidence** of MZL seen by gastroendoscopy, with specific conditions related to H. pylori infection.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of cancer other than Marginal Zone Lymphoma cannot participate. Marginal Zone Lymphoma is a type of cancer that affects certain white blood cells.
  • Patients who are not in need of treatment for their Marginal Zone Lymphoma are excluded.
  • Patients who have not failed or are eligible for local therapy are excluded. Local therapy refers to treatments that target the cancer in a specific area of the body.
  • Patients who have not relapsed, meaning their cancer has not returned after treatment, are excluded.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial group are excluded.
  • Patients who are considered part of a vulnerable population, meaning they may need special protection or care, are excluded.
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Investigated drugs

  • Copanlisib

    is a medication used in this trial to treat patients with Marginal Zone Lymphoma (MZL). It works by blocking certain proteins that help cancer cells grow and survive. The goal is to see how effective it is in stopping the cancer and to monitor any side effects it may cause.

  • Rituximab

    is another medication used in the trial. It is a type of therapy that targets specific cells in the immune system. Rituximab helps the body's immune system to attack and destroy cancer cells. The trial aims to evaluate how well it works in combination with Copanlisib for patients with MZL.

What is already known about the treatment

  • Copanlisib

    Copanlisib is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating Marginal Zone Lymphoma. It is primarily used for patients who have not responded to other treatments. Copanlisib works by inhibiting certain enzymes known as PI3K, which play a role in the growth and survival of cancer cells. It is classified as a PI3K inhibitor, a type of targeted cancer therapy.

  • Rituximab

    Rituximab is given through an intravenous infusion and is widely used in the treatment of various types of lymphoma, including Marginal Zone Lymphoma. It is a well-established medication in medical literature and is often used in combination with other drugs. Rituximab targets a specific protein called CD20 found on the surface of B-cells, leading to the destruction of these cells. It is classified as a monoclonal antibody, which is a type of immunotherapy.

Investigated diseases

Marginal Zone Lymphoma – Marginal Zone Lymphoma (MZL) is a type of non-Hodgkin lymphoma that originates from B-cells, which are a type of white blood cell. It typically affects the marginal zone of lymphoid tissues, which is the area surrounding the follicles in lymph nodes, spleen, or mucosal-associated lymphoid tissue. MZL can be classified into three main subtypes: extranodal, nodal, and splenic, depending on where it develops in the body. The disease often progresses slowly, and symptoms may include swelling of lymph nodes, fatigue, and weight loss. As it advances, MZL can spread to other parts of the body, including the bone marrow and blood. The progression and symptoms can vary significantly among individuals, with some experiencing more aggressive forms of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-500674-34-00Protocol codeCOUP-1Estimated enrolment36 patientsSponsorUniversitaetsklinikum Ulm AöR

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