Suspended

OptiMATeDe-escalated Induction Treatment vs. Standard MATRix Protocol in Newly Diagnosed Primary CNS Lymphoma

Study Aim

This study aims to compare the effectiveness of a de-escalated induction treatment versus the standard MATRix protocol in newly diagnosed primary Central Nervous System Lymphoma patients, by observing the event-free survival rate, which is the time from randomization to premature end of treatment due to any reason, lymphoma progression or death, whichever occurs first.

What is being tested

Experimental Treatment: one course Rituximab/HD-Methotrexate, two courses of MATRix

+ Control intervention: four courses of MATRix

Drug

Who is being recruted

From 18 to 70 Years

+29 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: June 2021

See protocol details

Summary

Principal SponsorKlinikum Stuttgart

Last updated: March 19, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 28, 2021

Actual date on which the first participant was enrolled.

This is a treatment-focused, phase III clinical trial. It aims to find out if a less intense initial treatment for newly diagnosed primary Central Nervous System (CNS) lymphoma, a type of cancer that starts in the brain or spinal cord, is more effective than the current standard treatment, known as the MATRix protocol. The goal is to improve event-free survival, which means helping patients live longer without their disease getting worse or needing to stop treatment. This study is important because it could lead to better treatment options for people with this condition. In this trial, participants are divided into two groups. One group receives the experimental treatment, which includes one course of a treatment called R/HD-MTX, followed by two courses of the MATRix protocol and a procedure called autologous stem cell transplantation. The other group receives the standard treatment, which involves four courses of the MATRix protocol followed by autologous stem cell transplantation. The study measures the results by looking at the time from when a participant is randomly assigned to a treatment group until their treatment ends prematurely for any reason, their disease gets worse, or they pass away, whichever happens first.

Official TitleOptimizing MATRix as Remission Induction in PCNSL: De-escalated Induction Treatment in Newly Diagnosed Primary CNS Lymphoma - a Randomized Phase III Trial

NCT04931368

Principal SponsorKlinikum Stuttgart

Last updated: March 19, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

331 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

9 inclusion criteria required to participate

Previously untreated patients (previous or ongoing steroid treatment admitted)

Negative pregnancy test

Immunocompetent patients with newly diagnosed primary diffuse large B-cell lymphoma of the central nervous system (PCNSL)

Male or female patients aged 18-65 years irrespective of ECOG or 66-70 years with ECOG Performance Status <= 2

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20 exclusion criteria prevent from participating

Primary vitreoretinal lymphoma without manifestation in the brain parenchyma or spinal cord

Inadequate bone marrow, cardiac, pulmonary or hepatic function according to investigator´s decision

Taking any medications that are likely to cause interactions with the study medication

Active COVID-19-infection or non-compliance with the prevailing hygiene measures regarding the COVID-19 pandemic

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

As induction treatment, patients receive one course of Rituximab/HD-Methotrexate (Rituximab 375 mg/m2, HD-Methotrexate 3.5 g/m2; i.v.). In the absence of clinical signs of progression, patients proceed to two courses of MATRix (Rituximab 2 x 375 mg/m2, HD-Methotrexate 3.5 g/m2, HD-Cytarabine 2 x 2 g/m2, Thiotepa 30 mg/m2; i.v.) followed by a response assessment with gadolinium-enhanced brain MRI (centrally reviewed). Patients with at least PR will proceed to HCT-ASCT (BCNU 400 mg/m2, thiotepa 4 x 5 mg/kg; i.v.). Collection of autologous stem cells is planed after the first course of MATRix

Group II

Active Comparator

Patients receive four courses of MATRix (Rituximab 2 x 375 mg/m2, HD-Methotrexate 3.5 g/m2, HD-Cytarabine 2 x 2 g/m2, Thiotepa 30 mg/m2; i.v.) as induction treatment. Response assessment with gadolinium-enhanced brain MRI (centrally reviewed) takes place after course two and four. Patient with at least PR proceed to 3rd course of MATRix after first response assessment and to HCT-ASCT (BCNU 400 mg/m2, Thiotepa 4 x 5 mg/kg; i.v.) after second response assessment. Collection of autologous stem cells is planed after the second course of MATRix.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Klinikum Stuttgart

Stuttgart, GermanyOpen Klinikum Stuttgart in Google Maps

SuspendedOne Study Center