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Study on Chlorambucil and Rituximab for Patients with MALT Lymphoma

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 a type of cancer called Extranodal Marginal Zone B-cell Lymphoma of Mucosa Associated Lymphoid Tissue (MALT Lymphoma). The study is investigating the effects of a treatment combination that includes two medications: Chlorambucil and Rituximab. Chlorambucil is given in tablet form, while Rituximab is administered as a solution for injection under the skin, known as subcutaneous injection. The purpose of the study is to evaluate the safety and effectiveness of this treatment combination.

Participants in the study will first receive a combination of Chlorambucil and Rituximab for a period of six months. After this initial phase, they will continue with a maintenance treatment using only Rituximab, which will be given as a subcutaneous injection for an additional two years. This approach aims to manage the lymphoma effectively over a longer period. The study will also include a group receiving a placebo to compare the results.

The trial will monitor various outcomes, such as the rate of complete remission, which means the disappearance of all signs of cancer in response to treatment, and the overall survival of participants. Other aspects being observed include how long participants remain free from disease progression and any side effects that may occur during and after the treatment. The study is designed to provide valuable information on the potential benefits and risks of using Chlorambucil and Rituximab together for treating MALT Lymphoma.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Induction phase

    The initial phase of the study involves a combination treatment with chlorambucil and rituximab. This phase lasts for 6 months.

    Chlorambucil is administered orally. The specific dosage and frequency will be determined by the healthcare provider based on individual needs.

    Rituximab is given as a subcutaneous injection, which means it is injected under the skin. The dosage and frequency will be specified by the healthcare provider.

  2. Step 2

    Maintenance phase

    Following the induction phase, the study continues with a maintenance phase lasting 2 years.

    During this phase, rituximab is administered alone as a subcutaneous injection. The frequency of these injections will be determined by the healthcare provider.

  3. Step 3

    Evaluation and follow-up

    Throughout the study, regular evaluations will be conducted to monitor the response to treatment and any side effects.

    The primary goal is to assess the complete remission rate at the end of the 6-month induction phase.

    Secondary evaluations include response rates, progression-free survival, event-free survival at 5 years, overall survival, response duration, and both acute and long-term toxicity.

Who can join the trial?

8 criteria

  • You must have a confirmed diagnosis of **Extranodal Marginal Zone Lymphoma**. This is a type of cancer that affects certain white blood cells and occurs outside of the lymph nodes.
  • The lymphoma must be **CD20-positive**. This means that the cancer cells have a specific protein on their surface that can be targeted by certain treatments.
  • The lymphoma should be of the **MALT type**. MALT stands for Mucosa-Associated Lymphoid Tissue, which is a type of tissue found in various parts of the body.
  • The lymphoma can be either a new diagnosis (**de novo**) or have returned after previous local treatments like surgery, radiation, or antibiotics for a specific stomach infection.
  • You must have a **measurable or evaluable disease**. This means that the cancer can be measured or assessed by doctors to see how it responds to treatment.
  • The lymphoma can be at **any stage** from I to IV, according to the Ann Arbor staging system, which is a way to describe how much the cancer has spread.
  • You must be **18 years or older** to participate.
  • Both **men and women** are eligible to participate in the study.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of lymphoma other than Extranodal Marginal Zone Lymphoma cannot participate. This is a specific type of cancer that affects certain immune system cells.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
  • Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate. This includes conditions that could make it unsafe for them to take the study medications.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
  • Patients who have participated in another clinical trial recently may not be eligible. This is to avoid any interference with the study results.
  • Patients who have allergies to the study medications, such as Chlorambucil or Rituximab, cannot participate. These are the drugs being tested in the study.
  • Patients who have a history of certain infections or diseases that could affect the study results cannot participate.
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Investigated drugs

  • Chlorambucil

    is a medication used in this study to help treat a type of cancer called MALT lymphoma, which affects certain immune system cells. It works by slowing or stopping the growth of cancer cells. In this trial, Chlorambucil is combined with another medication to see how well they work together.

  • Rituximab

    is another medication used in this study. It is given as an injection under the skin and is used to target and destroy specific cancer cells in MALT lymphoma. In the trial, Rituximab is first combined with Chlorambucil for six months to see how effective the combination is. After that, Rituximab is continued alone for two years as a maintenance therapy to help keep the cancer from coming back.

What is already known about the treatment

  • Chlorambucil

    Chlorambucil is administered orally in tablet form and is currently used in the treatment of certain types of cancer, including extranodal marginal zone lymphoma. It is classified as an alkylating agent, which works by interfering with the DNA replication process in cancer cells, ultimately leading to cell death. This medication is well-documented in medical literature for its effectiveness in treating various lymphomas.

  • Rituximab

    Rituximab is administered subcutaneously and is used in the treatment of extranodal marginal zone lymphoma, among other conditions. It is a monoclonal antibody that targets the CD20 protein found on the surface of B-cells, leading to their destruction. Rituximab is widely recognized in medical literature for its role in treating B-cell lymphomas and is classified as a biologic therapy.

Investigated diseases

Extranodal Marginal Zone Lymphoma – This is a type of non-Hodgkin lymphoma that originates in the marginal zone of lymphoid tissue, often affecting areas outside the lymph nodes, such as the stomach, lungs, or thyroid. It is part of a group of diseases known as MALT (mucosa-associated lymphoid tissue) lymphomas. The disease typically progresses slowly and may remain localized for a long time before spreading. Symptoms can vary depending on the affected area but may include swelling, pain, or discomfort in the involved organ. It is considered a rare disease and is often diagnosed in middle-aged or older adults.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507291-52-00Protocol codeIELSG38Estimated enrolment112 patientsSponsorAssociation International Extranodal Lymphoma Study Group (IELSG)

sourced from the EU Clinical Trials Register and site verification

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