RecruitingPhase 3NCT06830421

Adjusted High-dose Chemotherapy With Autologous Stem Cell Transplant vs. Conventional Immunochemotherapy in Elderly PCNSL Patients

Age-adjusted High-dose Chemotherapy Followed by Autologous Stem Cell Transplantation or Conventional Chemotherapy With R-MP as First-line Treatment in Elderly Primary CNS Lymphoma Patients - a Randomized Phase III Trial

Sponsor

University Hospital Freiburg

Enrollment

340 participants

Start Date

Aug 9, 2023

Study Type

INTERVENTIONAL

Conditions

Primary Central Nervous System Lymphoma

Summary

Most patients being diagnosed with primary diffuse large B-cell lymphoma of the central nervous system (PCNSL) are 60 years or older. Elderly patients with PCNSL have a poor prognosis and there is a great medical need to improve outcome for this vulnerable population. In Germany and many international centres, there are currently two widely used strategies to treat elderly PCNSL patients who are eligible for high-dose methotrexate (HD-MTX) treatment, which have not yet been compared head-to-head. The R-MP regimen has been established by the Cooperative PCNSL Study Group as a "conventional" immunochemotherapy standard treatment for elderly patients with newly diagnosed disease and consists of Rituximab, HD-MTX and Procarbazine followed by maintenance therapy with Procarbazine. In contrast, another recently established protocol also includes HD-MTX-based induction therapy, but followed by consolidating high-dose chemotherapy and autologous stem cell transplantation (HCT-ASCT). This is an overall more intensive, but substantially shorter treatment approach, feasible for elderly patients being considered eligible for a more intensive treatment. The PRIMA-CNS trial aims to compare these two treatment approaches with respect to survival, response rates and toxicity.

Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a high-dose chemotherapy treatment followed by a stem cell transplant works better than standard chemotherapy for older adults with a type of brain lymphoma called primary central nervous system lymphoma (PCNSL). Researchers want to find the best treatment approach for elderly patients with this rare cancer. **You may be eligible if...** - You are 70 years or older (or 65–70 if your doctor feels standard intensive treatment is not appropriate for you) - You have been newly diagnosed with a B-cell lymphoma located only in the brain or spinal cord - Your cancer was confirmed by a biopsy or spinal fluid test - Your overall health and functioning level is reasonably good - Your doctor believes you could tolerate a stem cell transplant **You may NOT be eligible if...** - You have HIV, a weakened immune system, or have had an organ transplant - Your lymphoma has spread outside the brain or spinal cord - You have had a previous lymphoma diagnosis - Your kidneys, liver, heart, or lungs are not functioning adequately - You have active hepatitis B or C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGR-MP and Procarbazine maintenance

Firstline systemic treatment with conventinal immunochemotherapy (3 cycles of Rituximab-MTX-Procarbazine) followed by Procarbazine maintenance

DRUGR-MTX/AraC (MARTA) induction followed by consolidating HCT-ASCT

Firstline systemic treatment with age-adjusted MTX based induction (2 cycles of Rituximab-Methotrexate-Cytarabin) followed by consolidating aged-adapted high-dose chemotherapy and autologous stem cell transplantation

Locations(35)

University Hospital Freiburg, Department Medicine I, Hematology, oncology and stem cell transplantation

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Klinikum Stuttgart, Clinic of Hematology, Oncology and Palliative Care, Stuttgart Cancer Center / Tumor Center Eva Mayr-Stihl

Stuttgart, Baden-Wurttemberg, Germany

University Hospital Aachen

Aachen, Germany

University Hospital Augsburg

Augsburg, Germany

Helios Klinikum Berlin-Buch

Berlin, Germany

University Hospital Berlin

Berlin, Germany

Evangelisches Klinikum Bethel

Bielefeld, Germany

Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH

Bochum, Germany

Städtisches Klinikum Braunschweig gGmbH

Braunschweig, Germany

Klinikum Bremen-Mitte gGmbH

Bremen, Germany

Klinikum Chemnitz gGmbH

Chemnitz, Germany

Universitätsklinikum Köln

Cologne, Germany

Carl Gustav Carus Universitätsklinikum Dresden

Dresden, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Universitätsklinikum Erlangen

Erlangen, Germany

Universitätsklinikum Essen

Essen, Germany

Klinikum der Johann-Wolfgang-Goethe-Universität

Frankfurt, Germany

Universitätsmedizin Göttingen Georg-August-Universität

Göttingen, Germany

Universitätsklinikum Halle (Saale)

Halle, Germany

Universitätsklinikum des Saarlandes Homburg

Homburg, Germany

Städtisches Klinikum Karlsruhe

Karlsruhe, Germany

Universitätsklinkum Schleswig-Holstein, Campus Kiel

Kiel, Germany

Gemeinschaftsklinikum Mittelrhein gGmbH - Koblenz Ev. Stift St. Martin

Koblenz, Germany

Universitätsklinikum Leipzig

Leipzig, Germany

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, Germany

Klinikum rechts der Isar TU München

München, Germany

Universitätsklinikum Münster

Münster, Germany

Universitätsklinik der Paracelsus Medizinischen Privatuniversität

Nuremberg, Germany

Pius-Hospital Oldenburg

Oldenburg, Germany

Klinikum Oldenburg gGmbh

Oldenburg in Holstein, Germany

Universitätsklinikum Regensburg

Regensburg, Germany

Universitätsmedizin Rostock

Rostock, Germany

Universtitätsklinikum Tübingen

Tübingen, Germany

Universitätsklinikum Ulm

Ulm, Germany

Schwarzwald-Baar-Klinikum Villingen-Schwenningen

Villingen-Schwenningen, Germany

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06830421

Related Trials

Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib,Rituximab (TEDDI-R) in Primary CNS Lymphoma

NCT022035261 location

A Multicenter Two-Cohort Study of Methotrexate, Rituximab, Sintilimab and Pirtobrutinib for Treatment-Naive PCNSL vs. Real-World Investigator-Selected Treatment (Observational Cohort)

NCT073508503 locations

Zanubrutinib With Pemetrexed to Treat Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphomas

NCT056811951 location

Pembrolizumab + Chemotherapy in Newly Diagnosed PCNSL

NCT064752352 locations

Pembrolizumab, Ibrutinib and Rituximab in PCNSL

NCT044215604 locations