Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

RecruitingRare disease

Study on High-Dose Chemotherapy with Cytarabine and Drug Combination for Elderly Patients with Primary CNS Lymphoma

Fast replyRegistered 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 rare type of cancer called Primary Central Nervous System Lymphoma (PCNSL), which affects the brain and spinal cord. This condition is most common in people aged 60 and older and often has a poor outlook. The trial aims to find the best treatment approach for elderly patients who have been newly diagnosed with this disease. The study will compare two treatment methods: one involves high-dose chemotherapy followed by a procedure called autologous stem cell transplantation (HCT-ASCT), and the other uses a more conventional chemotherapy regimen known as R-MP.

The medications being tested in this trial include CYTARABINE, PROCARBAZINE, THIOTEPA, BUSULFAN, RITUXIMAB, and METHOTREXATE DISODIUM. These drugs are used in different forms, such as solutions for infusion or capsules, and are administered either intravenously or orally. The trial will also involve a placebo group to help determine the effectiveness of the treatments. The purpose of the study is to see if the intensified chemotherapy followed by HCT-ASCT is more effective than the conventional R-MP chemotherapy in terms of how long patients live without the disease getting worse.

Participants in the study will receive one of the two treatment plans and will be monitored over time to assess their quality of life, the remission of the disease, and any side effects they may experience. The study will also look at overall survival rates and any treatment-related issues, such as neurotoxicity, which refers to damage to the nervous system. The trial is expected to continue for several years, with the goal of providing valuable information on the best treatment options for elderly patients with PCNSL.

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

    Initial treatment phase

    The initial treatment phase involves the administration of rituximab and methotrexate disodium. These medications are given as a solution for infusion, which means they are delivered directly into the bloodstream through a vein.

    This phase aims to reduce the size of the lymphoma and prepare the body for the next steps in the treatment process.

  2. Step 2

    Intensified chemotherapy

    During this phase, a combination of cytarabine, procarbazine, thiotepa, and busulfan is administered. These medications are given intravenously, except for procarbazine, which is taken orally.

    The purpose of this intensified chemotherapy is to further target and destroy cancer cells in the central nervous system.

  3. Step 3

    Consolidation treatment

    Following the intensified chemotherapy, a high-dose chemotherapy regimen is administered. This is followed by an autologous stem cell transplantation (HCT-ASCT).

    The goal of this consolidation treatment is to eliminate any remaining cancer cells and to help restore the body's ability to produce healthy blood cells.

  4. Step 4

    Maintenance treatment

    In the maintenance treatment phase, the focus is on sustaining remission and preventing the recurrence of lymphoma.

    This phase may involve ongoing monitoring and additional treatments as necessary, based on the patient's response to the previous phases.

  5. Step 5

    Follow-up and monitoring

    Regular follow-up appointments are scheduled to monitor the patient's health and to assess the effectiveness of the treatment.

    During these visits, quality of life assessments and other evaluations are conducted to ensure the patient's well-being and to detect any potential complications early.

Who can join the trial?

11 criteria

  • Patients must have a new diagnosis of **primary diffuse large B-cell lymphoma** in the **central nervous system**. This means the cancer is only in the brain or spinal cord.
  • Patients should be **over 70 years old**. If they are between 65 and 70 years old, they must not be eligible for more intense treatments.
  • The diagnosis must be confirmed by a local pathologist, which is a doctor who examines tissues to diagnose diseases.
  • A sample for diagnosis must be obtained through a **stereotactic or surgical biopsy**, **CSF cytology examination**, or **vitrectomy**. These are methods to collect tissue or fluid for testing.
  • The disease must be located only in the **central nervous system**.
  • There must be at least one **measurable lesion**, which is an area of cancer that can be measured.
  • The **ECOG Performance Status** must be 2 or less. This is a scale that measures how well a patient can perform daily activities.
  • Patients should be possibly eligible for **HCT-ASCT**, which is a type of stem cell transplant, as judged by their doctor.
  • Patients or their legal representatives must provide **written informed consent** according to international guidelines and local laws.
  • Patients must be eligible for **HCT-ASCT** based on specific criteria, including an **EBL score**. This score considers the patient's ability to perform daily activities and overall health.
  • There should be no evidence of the disease getting worse after initial treatment.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of lymphoma that is not the specific type being studied in this trial.
  • Patients who have had previous treatments that might interfere with the study's results.
  • Patients who have other serious health conditions that could make it unsafe for them to participate.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who are pregnant or breastfeeding, as the treatments might affect the baby.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have allergies or reactions to the medications used in the study.
  • Patients who have a history of certain mental health conditions that could affect their ability to participate.
  • Patients who have infections that are not well controlled, as this could affect their safety during the trial.
  • Patients who have had a recent major surgery that might affect their recovery or the study results.
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

  • High-Dose Chemotherapy

    is a treatment approach that uses higher than usual doses of chemotherapy drugs to kill cancer cells. In this trial, it is followed by a procedure called autologous stem cell transplantation, where a patient's own stem cells are used to help recover the bone marrow after the high-dose chemotherapy.

  • Autologous Stem Cell Transplantation (HCT-ASCT)

    involves collecting and using a patient's own stem cells to restore bone marrow function after intensive chemotherapy. This process helps the body recover and produce healthy blood cells more quickly.

  • Conventional Chemotherapy with R-MP

    refers to a standard chemotherapy regimen that includes a combination of drugs. R-MP typically involves the use of rituximab, a monoclonal antibody that targets specific cancer cells, along with other chemotherapy drugs to treat lymphoma.

  • Maintenance Therapy

    is a treatment given to help keep cancer from coming back after it has responded to initial therapy. In this trial, it is used following conventional chemotherapy to prolong the period of remission in patients.

What is already known about the treatment

R-MP (Rituximab, Methotrexate, Procarbazine) – This medication is administered intravenously and is used in the treatment of primary diffuse large B-cell lymphoma of the central nervous system, particularly in elderly patients. It is currently being evaluated in clinical trials to determine its effectiveness compared to high-dose chemotherapy followed by autologous stem cell transplantation. The main therapeutic indication is to improve progression-free survival in patients with this type of lymphoma. At the molecular level, Rituximab targets CD20 on B-cells, Methotrexate inhibits dihydrofolate reductase affecting DNA synthesis, and Procarbazine interferes with DNA replication. This combination is classified as an antineoplastic regimen.

Investigated diseases

Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System – This is a rare type of lymphoma that specifically affects the central nervous system, which includes the brain and spinal cord. It is characterized by the presence of large B-cells, a type of white blood cell, that grow uncontrollably within the central nervous system. The disease typically occurs in individuals who are 60 years or older. It progresses by causing neurological symptoms due to the growth of lymphoma cells in the brain or spinal cord. As the disease advances, it can lead to increased pressure within the skull and other complications related to the central nervous system. The progression of this lymphoma is often aggressive, requiring careful management to address the symptoms and impact on the nervous system.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2024-512320-11-00Protocol codeP003077Estimated enrolment260 patientsSponsorMedical Center - University Of Freiburg

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.