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Taking people in GermanyPhase 3

Tests two chemotherapy approaches for older adults with brain lymphoma

Tests chemotherapy with stem cell transplant against standard chemotherapy in adults with brain lymphoma.

Key facts

Who runs it
Medical Center - University Of Freiburg
Where
Aachen, Augsburg, Berlin, Bielefeld, Bremen, Brunswick, Chemnitz, Cologne, Dresden, Duesseldorf, Erlangen, Essen, Frankfurt Am Main, Freiburg im Breisgau, Goettingen, Halle (Saale), Hamburg, Homburg, Karlsruhe, Kiel, Koblenz, Leipzig, Luebeck, Magdeburg, Mainz, Muenster, Munich, Nuremberg, Oldenburg, Regensburg, Rostock, Siegen, Stuttgart, Trier, Tuebingen, Ulm, and Villingen-Schwenningen, GermanySee the 41 sitesAlso in 1 other country, 4 sites
Registry title
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 - PRIMA-CNS
Status
Recruiting
Phase
Phase 3
People taking part
260 people, planned
Started
9 Aug 2023
Expected to end
31 Mar 2031
Type of study
Interventional
Record updated
13 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for older adults with newly found lymphoma that is only in the brain, spinal cord or their fluid (primary CNS lymphoma). It compares two first treatments.

Age
Older than 70 years, or 65-70 years if not able to have more intensive treatment.
Sex
All sexes can join.
Disease stage
Newly diagnosed B-cell lymphoma (DLBCL) of the central nervous system only, with at least 1 measurable lesion. ECOG performance status 2 or lower. The treating doctor must judge that a stem cell transplant is possible.
Earlier treatment
No earlier treatment for this lymphoma is described. For the randomization step there must be no sign of the disease getting worse after a first short treatment phase. Earlier non-Hodgkin lymphoma of any kind rules a person out.

Main reasons for not taking part

  • Weak immune system from birth or later, including HIV infection or an earlier organ transplant
  • Lymphoma outside the central nervous system
  • Eye-only lymphoma or lymphoma of the membranes around the brain only, with no spread to brain tissue or spinal cord
  • Another cancer now or before, except when none was seen for at least 5 years
  • Poor kidney function (creatinine clearance under 60 ml/min) or poor bone marrow, heart, lung or liver function

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • Immunocompetent patients with newly-diagnosed primary DLBCL of the central nervous system. 2. Age > 70 years or age 65-70 years if not eligible for more intensive treatment (e.g. OptiMATe trial). 3. Histologically or cytologically assessed diagnosis of B -cell lymphoma by local pathologist. 4. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy. 5. Disease exclusively located in the CNS. 6. At least 1 measurable lesion. 7. ECOG-Performance Status ≤2. 8. Patients possibly eligible for HCT-ASCT as judged by the treating physician. 9. Written informed consent obtained according to international guidelines and local laws by patient or authorized legal representative in case patient is temporarily legally not competent due to his or her disease. Additional randomization criteria: 1. Patients eligible for HCT-ASCT defined by the EBL score (at most 1 of the 3 following conditions may apply: ECOG PS > 1, Barthel Index of ADL < 20 and Lachs geriatric screening > 3), improvement of PS after prephase treatment or clinical judgement by the treating physician after discussion with the study expert team. 2. No evidence of disease progression after pre-phase treatment

Who cannot take part

  • Congenital or acquired immunodeficiency including HIV infection and previous organ transplantation. 2. Systemic lymphoma manifestation (outside the CNS). 3. Primary vitreoretinal lymphoma or primary leptomeningeal lymphoma without manifestation in the brain parenchyma or spinal cord. 4. Previous or concurrent malignancies with the exception of surgically cured carcinoma in situ or other kinds of cancer without evidence of disease for at least 5 years. 5. Previous systemic Non-Hodgkin lymphoma at any time. 6. Inadequate renal function (creatinine clearance <60 ml/min). 7. Inadequate bone marrow, cardiac, pulmonary or hepatic function according to investigator´s decision. 8. Active hepatitis B or C disease. 9. Concurrent treatment with other experimental drugs or participation in an interventional clinical trial with administration of study medication within the last 30 days before the start of this study. 10. Clinically relevant third space fluid accumulation according to the investigator's discretion. 11. Hypersensitivity to study treatment or any component of the formulation. 12. Taking any medications likely to cause interactions with the study medication. 13. Known or persistent abuse of medication, drugs or alcohol. 14. Active COVID-19-infection or non-compliance with the prevailing hygiene measures regarding the COVID-19 pandemic. 15. Patients without legal capacity and who are unable to understand the nature, significance and consequences of the study and without designated legal representative. 16. Previous participation in this trial. 17. Persons who are in a relationship of dependency/employment to the sponsor and/ or investigator. 18. Any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. 19. Fertile patients refusing to use safe contraceptive methods during the study

Where in Germany

Also in 1 other country, 4 sites

  • Universitaetsklinikum Aachen AöRAachen, GermanyTaking people
  • Universitaetsklinikum AugsburgAugsburg, GermanyTaking people
  • Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
  • Evangelisches Klinikum Bethel gGmbHBielefeld, GermanyTaking people
  • Klinikum Bielefeld gGmbHBielefeld, GermanyTaking people
  • Gesundheit Nord gGmbH Klinikverbund BremenBremen, GermanyTaking people
  • Staedtisches Klinikum Braunschweig gGmbHBrunswick, GermanyTaking people
  • Klinikum Chemnitz gGmbHChemnitz, GermanyTaking people
  • University Hospital Cologne AöRCologne, GermanyTaking people
  • Technische Universitaet DresdenDresden, GermanyTaking people
  • Universitaetsklinikum Duesseldorf AöRDuesseldorf, GermanyTaking people
  • Universitaetsklinikum Erlangen AöRErlangen, GermanyTaking people
  • Universitaetsklinikum Essen (AoR)Essen, GermanyTaking people
  • Goethe University FrankfurtFrankfurt Am Main, GermanyTaking people
  • Medical Center- University of FreiburgFreiburg im Breisgau, GermanyTaking people
  • Universitaetsmedizin GoettingenGoettingen, GermanyTaking people
  • Martin-Luther-Universitaet Halle-WittenbergHalle (Saale), GermanyTaking people
  • University Medical Center Hamburg-EppendorfHamburg, GermanyTaking people
  • Universitaet Des SaarlandesHomburg, GermanyTaking people
  • Staedtisches Klinikum Karlsruhe gGmbHKarlsruhe, GermanyTaking people
  • Universitaetsklinikum Schleswig-Holstein AöRKiel, GermanyTaking people
  • Gemeinschaftsklinikum Mittelrhein gGmbHKoblenz, GermanyTaking people
  • Universitaetsklinikum Leipzig AorLeipzig, GermanyTaking people
  • Universitaetsklinikum Schleswig-Holstein AöRLuebeck, GermanyTaking people
  • Universitaetsklinikum Magdeburg AöRMagdeburg, GermanyTaking people
  • Johannes Gutenberg University MainzMainz, GermanyTaking people
  • Universitaetsklinikum Muenster AöRMuenster, GermanyTaking people
  • Klinikum rechts der Isar der TU Muenchen AöRMunich, GermanyTaking people
  • LMU Klinikum Muenchen AöRMunich, GermanyTaking people
  • Klinikum NuernbergNuremberg, GermanyTaking people
  • Klinikum Oldenburg AorOldenburg, GermanyTaking people
  • Pius Hospital OldenburgOldenburg, GermanyTaking people
  • Barmherzige Brueder gemeinnuetzige Krankenhaus GmbHRegensburg, GermanyTaking people
  • Universitaetsklinikum Regensburg AöRRegensburg, GermanyTaking people
  • Rostock University Medical CenterRostock, GermanyTaking people
  • Diakonie in Suedwestfalen gGmbHSiegen, GermanyTaking people
  • Klinikum Der Landeshauptstadt Stuttgart gKAöRStuttgart, GermanyTaking people
  • Barmherzige Brueder Trier gGmbHTrier, GermanyTaking people
  • Universitaetsklinikum Tuebingen AöRTuebingen, GermanyTaking people
  • Universitaetsklinikum Ulm AoRUlm, GermanyTaking people
  • Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbHVillingen-Schwenningen, GermanyTaking people

About the trial

What the trial wants to find out

Primary: To demonstrate that intensified chemotherapy followed by consolidating high-dose chemotherapy and autologous stem-cell transplantation (HCT-ASCT) is superior to conventional chemotherapy with R-MP followed by maintenance in elderly patients with newly diagnosed PCNSL in terms of progression free survival (PFS). Secondary: To compare quality of life, remission after induction treatment, remission after maintenance treatment (arm A) / consolidation treatment (arm B), event free survival, overall survival and treatment related morbidities (neurotoxicity and adverse events) between both treatment arms.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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 - PRIMA-CNS
Plain-language title
Tests two chemotherapy approaches for older adults with brain lymphomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
13 October 2026