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Study on De-escalated Induction Therapy with Methotrexate, Cytarabine, Thiotepa, and Rituximab for Newly Diagnosed Primary CNS Lymphoma Patients

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 a rare type of cancer called Primary Central Nervous System Lymphoma (PCNSL), which affects the brain, spinal cord, or eyes. The trial aims to explore a new treatment approach for patients who have been newly diagnosed with this condition. The treatment being tested is a combination of medications known as MATRix, which includes Methotrexate, Ara-C (also known as Cytarabine), Thiotepa, and Rituximab. These medications are given as an initial therapy to see if a reduced duration and total dose can be as effective as the standard treatment. The study will also involve a high-dose therapy followed by a procedure called autologous stem cell transplantation, where a patient's own stem cells are used to help recover from the treatment.

The purpose of this study is to determine if the new treatment strategy can improve the time patients remain free from events such as treatment failure, cancer progression, or death, compared to the standard approach. Participants in the study will receive the medications through an intravenous infusion, which means the drugs are delivered directly into the bloodstream. The study will compare the outcomes of the new treatment plan with the standard treatment to see which is more effective in helping patients achieve remission, which is a period when the cancer is not active.

Throughout the study, researchers will monitor various aspects of the participants' health, including overall survival, progression-free survival, and quality of life. The trial is expected to continue until 2030, allowing researchers to gather comprehensive data on the effectiveness and safety of the new treatment approach. This study is an important step in finding better ways to treat PCNSL and improve the lives of those affected by this challenging condition.

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, including age, diagnosis, and health status.

    A written informed consent is required to participate in the trial.

  2. Step 2

    Induction therapy

    The induction therapy involves a combination of medications: methotrexate, ara-C (cytarabine), thiotepa, and rituximab.

    These medications are administered intravenously, meaning they are given directly into a vein.

    The treatment is de-escalated, meaning the duration and total dose are reduced compared to the standard protocol.

  3. Step 3

    High dose therapy

    Following the induction therapy, a high dose therapy is administered.

    This phase is designed to prepare for the next step, which involves stem cell transplantation.

  4. Step 4

    Autologous stem cell transplantation

    Autologous stem cell transplantation involves using the patient's own stem cells to help restore bone marrow function after high dose therapy.

    This step is crucial for recovery and aims to improve the chances of remission.

  5. Step 5

    Follow-up and monitoring

    After the transplantation, regular follow-up appointments are scheduled to monitor health and response to treatment.

    Quality of life assessments are conducted using specific questionnaires at various intervals, including 30 days after transplantation and annually thereafter.

Who can join the trial?

10 criteria

  • Patients must be **immunocompetent**, meaning their immune system is working normally.
  • Patients should have a new diagnosis of **primary diffuse large B-cell lymphoma of the central nervous system (PCNSL)**, which is a type of cancer affecting the brain and spinal cord.
  • Both men and women aged 18-65 years can participate, regardless of their **Karnofsky Performance Status (KPS)**, which measures their ability to perform daily activities. Patients aged 66-70 years can participate if their KPS is 50% or higher.
  • The diagnosis must be confirmed by examining tissue samples under a microscope, which can be obtained through a small surgery or other specific tests.
  • The disease must be located only in the central nervous system (CNS), which includes the brain and spinal cord.
  • There must be at least one **measurable lesion**, which is an area of abnormal tissue that can be measured.
  • Patients should not have received any previous treatment for this condition, although previous surgery or ongoing steroid treatment is allowed.
  • Women who can have children must have a negative pregnancy test.
  • Patients must provide written informed consent, which means they agree to participate after understanding the study details. If a patient cannot legally give consent due to their condition, a legal representative can do so on their behalf.
  • Patients must be able to understand the study and follow the procedures, unless they are unable to do so due to their condition, in which case the previous consent rule applies.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of lymphoma that is not the specific type being studied.
  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who have a history of substance abuse that could affect their participation.
  • Patients who have had a recent major surgery or are planning to have surgery during the study.
  • Patients who have an active infection that requires treatment.
  • Patients who have a condition that affects their immune system, making them more vulnerable to infections.
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Investigated drugs

  • MATRix Protocol

    is a combination of medications used as a standard treatment for primary CNS lymphoma. It typically includes a mix of chemotherapy drugs designed to target and destroy cancer cells in the central nervous system. The goal of this protocol is to induce remission in patients by reducing the number of cancer cells.

  • Autologous Stem Cell Transplantation

    is a procedure where a patient's own stem cells are collected, stored, and then reintroduced into their body after intensive treatment. This therapy aims to restore the bone marrow's ability to produce healthy blood cells, which can be damaged during chemotherapy. It is used to help patients recover and maintain remission after initial cancer treatment.

What is already known about the treatment

MATRix Protocol – This medication regimen is administered intravenously and is used in the treatment of primary diffuse large B-cell lymphoma of the central nervous system (PCNSL). It is currently being evaluated in clinical trials to optimize its effectiveness as a remission induction therapy. The main therapeutic indication is for PCNSL, a rare type of lymphoma affecting the brain and spinal cord. The mechanism of action involves targeting and destroying rapidly dividing cancer cells, although the exact molecular interactions can vary depending on the specific drugs used in the protocol. MATRix is classified as a chemotherapy regimen, combining multiple drugs to enhance treatment efficacy.

Investigated diseases

Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System – This is a rare type of lymphoma that is confined to the brain, spinal cord, eyes, or the membranes covering the brain and spinal cord. It represents a small percentage of all Non-Hodgkin's lymphomas and primary brain tumors. The disease has become more common over the past three decades, especially in individuals with normal immune function. It typically begins with symptoms related to the affected areas, such as neurological issues or vision problems. As the disease progresses, it can lead to more severe neurological impairments. The condition is characterized by its aggressive nature and rapid progression if left untreated.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514473-21-00Protocol codeSCC215/P002900Estimated enrolment326 patientsSponsorKlinikum Der Landeshauptstadt Stuttgart gKAöR

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