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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Jena KöR Jena Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Medizinische Universitaet Innsbruck Innsbruck Austria
Technische Universitaet Dresden Dresden Germany
Universitaetsmedizin Goettingen Goettingen Germany
Rostock University Medical Center Rostock Germany

Other Sites

Site Name City Country Status
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Klinikum Oldenburg AöR Oldenburg In Holstein Germany
Pius-Hospital Oldenburg Oldenburg In Holstein Germany
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Klinikum Der Landeshauptstadt Stuttgart gKAöR Stuttgart Germany
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Klinikum Chemnitz gGmbH Chemnitz Germany
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse Vienna Austria
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Staedtisches Klinikum Braunschweig gGmbH Brunswick Germany
Staedtisches Klinikum Karlsruhe gGmbH Karlsruhe Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Gesundheit Nord gGmbH Klinikverbund Bremen Bremen Germany
Universita Degli Studi Di Brescia Brescia Italy
Saarland University Hospital Homburg Germany
Evangelisches Klinikum Bethel gGmbH Bielefeld Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitaetsklinikum Leipzig AöR Leipzig Germany
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Ulejvmsnqmwvvgzxlvsza Mwuyztul Aut Munster Germany
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Aomripo Uow Iragi Dr Rvgnsc Eihylj Reggio Emilia Italy
Ujhtjbmfnq Mhqjqol Cnkzym Hrczcjrgpbkklqtom Hamburg Germany
Ulwoguhgpvndyskjtklpv Eljto Acy Essen Germany
Mulmsagpizhsuktrhbduymlpdd Hhqulyruvlgtobyf Halle (Saale) Germany
Utnkxqaqqxhhsxqzfvmjz Attofjbw Augsburg Germany
Aqzivdi Onqcjvsptvl Uwtgbuirieota Siilch Siena Italy
Giemcgkwxicbjrjgmfpwr Mjcqaudpbxg gluez Koblenz Germany
Uwrtfzmghf Hzpvwevs Csxxkem Cologne Germany
Uyopgontgvojqbgqqxsvd Dklsqrbchwh Adc Duesseldorf Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
02.08.2021
Germany Germany
Not recruiting
02.08.2021
Italy Italy
Not recruiting
02.08.2021

Trial locations

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.

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 ID:
2024-514473-21-00
Protocol code:
SCC215/P002900
NCT ID:
NCT04931368
Trial Phase:
Therapeutic confirmatory (Phase III)

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