AzTrials
AzTrials

Primary Central Nervous System LymphomaPhase 3PRIMA-CNSNCT06830421

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

A Phase 3 study testing R-MP and Procarbazine maintenance and R-MTX/AraC (MARTA) induction followed by consolidating HCT-ASCT in people with Primary Central Nervous System Lymphoma, run by University Hospital Freiburg at 35 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Primary Central Nervous System Lymphoma
What is being tested?
R-MP and Procarbazine maintenance and R-MTX/AraC (MARTA) induction followed by consolidating HCT-ASCT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
35 sitesGermany
Study dates
9 Aug 2023to 31 Aug 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Immunocompetent patients with newly-diagnosed primary DLBCL of the central nervous system.
  • Age > 70 years or age 65-70 years if not eligible for more intensive treatment (e.g. OptiMATe trial).
  • Histologically or cytologically assessed diagnosis of B-cell lymphoma by local pathologist.
  • Diagnostic sample obtained by stereotactic or surgical biopsy, cerebrospinal fluid (CSF) cytology examination or vitrectomy.
  • Disease exclusively located in the CNS.
  • At least 1 measurable lesion.
Show all 12Show fewer
  • Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) ≤ 2. ECOG PS > 2 accepted if due to PCNSL symptoms.
  • Patients possibly eligible for HCT-ASCT as judged by the treating physician.
  • 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:
  • Patients eligible for HCT-ASCT defined by the EBL score (at most one of the 3 following conditions may apply: ECOG PS > 1, Barthel Index of activities of daily living (ADL) < 20 and Lachs geriatric screening > 3), improvement of PS after pre-phase treatment or clinical judgement by the treating physician after discussion with the study expert team.
  • No evidence of disease progression after pre-phase treatment.

Who cannot join

  • Congenital or acquired immunodeficiency including HIV infection and previous organ transplantation.
  • Systemic lymphoma manifestation (outside the CNS).
  • Primary vitreoretinal lymphoma or primary leptomeningeal lymphoma without manifestation in the brain parenchyma or spinal cord.
  • 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.
  • Previous systemic Non-Hodgkin lymphoma at any time.
  • Inadequate renal function (creatinine clearance <60 ml/min).
Show all 19Show fewer
  • Inadequate bone marrow, cardiac, pulmonary or hepatic function according to investigator´s decision.
  • Active hepatitis B or C disease.
  • Concurrent treatment with other experimental drugs or participation in an interventional clinical trial with administration of study medication within the last thirty days before the start of this study.
  • Third space fluid accumulation >500 ml.
  • Hypersensitivity to study treatment or any component of the formulation.
  • Taking any medications likely to cause interactions with the study medication.
  • Known or persistent abuse of medication, drugs or alcohol.
  • Active COVID-19-infection or non-compliance with the prevailing hygiene measures regarding the COVID-19 pandemic.
  • Patients without legal capacity and who are unable to understand the nature, significance and consequences of the study and without designated legal representative.
  • Previous participation in this trial.
  • Persons who are in a relationship of dependency/employment to the sponsor and/ or investigator.
  • Any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  • Fertile patients refusing to use safe contraceptive methods during the study.

Trial locations and contacts

35 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Elisabeth Schorb, MD contact

+49 761 270-35360

elisabeth.schorb@uniklinik-freiburg.de

Gerald Illerhaus, MD contact

+49 711 278-30400

g.illerhaus@klinikum-stuttgart.de

35 sites in 1 country

Germany35 sites, 35 recruiting

  • University Hospital Aachen

    Aachen

    Jens Panse, MD, jpanse@ukaachen.de

    Recruiting

  • University Hospital Augsburg

    Augsburg

    Mathias Lutz, MD, mathias.lutz@uk-augsburg.de

    Recruiting

  • Helios Klinikum Berlin-Buch

    Berlin

    Christian Eimermacher, MD, Christian.eimermacher@helios-gesundheit.de

    Not yet recruiting

  • University Hospital Berlin

    Berlin

    Ulrich Keller, MD, ulrich.keller@charite.de

    Recruiting

  • Evangelisches Klinikum Bethel

    Bielefeld

    Bettina Zinngrebe, MD, bettina.zinngrebe@evkb.de

    Not yet recruiting

  • Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH

    Bochum

    Sabine Seidel, MD, Sabine.Seidel@kk-bochum.de

    Recruiting

  • Städtisches Klinikum Braunschweig gGmbH

    Braunschweig

    Carsten Springer, MD, c.springer@klinikum-braunschweig.de

    Recruiting

  • Klinikum Bremen-Mitte gGmbH

    Bremen

    Bernd Hertenstein, MD, bernd.hertenstein@klinikum-bremen-mitte.de

    Recruiting

  • Klinikum Chemnitz gGmbH

    Chemnitz

    Mathias Hänel, MD, m.haenel@skc.de

    Not yet recruiting

  • Universitätsklinikum Köln

    Cologne

    Heger Jan-Michel, MD, jan-michel.heger@uk-koeln.de

    Not yet recruiting

  • Carl Gustav Carus Universitätsklinikum Dresden

    Dresden

    Frank Kroschinsky, MD, frank.kroschinsky@uniklinikum-dresden.de

    Recruiting

  • Universitätsklinikum Düsseldorf

    Düsseldorf

    Guido Kobbe, MD, kobbe@med.uni-duesseldorf.de

    Not yet recruiting

  • Universitätsklinikum Erlangen

    Erlangen

    Stefan Krause, MD, stefan.krause@uk-erlangen.de

    Recruiting

  • Universitätsklinikum Essen

    Essen

    Bastian von Tresckow, MD, bastian.vontresckow@uk-essen.de

    Not yet recruiting

  • Klinikum der Johann-Wolfgang-Goethe-Universität

    Frankfurt

    Thomas Oellerich, MD, thomas.oellerich@kgu.de

    Recruiting

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

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

    Elisabeth Schorb, MD, +4976127035360, elisabeth.schorb@uniklinik-freiburg.de

    Lisa K Isbell, MD, lisa.isbell@uniklinik-freiburg.de

    Recruiting

  • Universitätsmedizin Göttingen Georg-August-Universität

    Göttingen

    Justin Hasenkamp, MD, j.hasenkamp@med.uni-goettingen.de

    Not yet recruiting

  • Universitätsklinikum Halle (Saale)

    Halle

    Thomas Weber, MD, thomas.weber@uk-halle.de

    Not yet recruiting

  • Universitätsklinikum des Saarlandes Homburg

    Homburg

    Lorenz Thurner, MD, lorenz.thurner@uks.eu

    Recruiting

  • Städtisches Klinikum Karlsruhe

    Karlsruhe

    Martin Bentz, MD, martin.bentz@klinikum-karlsruhe.de

    Recruiting

  • Universitätsklinkum Schleswig-Holstein, Campus Kiel

    Kiel

    Christine Pott, MD, c.pott@med2.uni-kiel.de

    Recruiting

  • Gemeinschaftsklinikum Mittelrhein gGmbH - Koblenz Ev. Stift St. Martin

    Koblenz

    Niemann Dirk, MD, Dirk.Niemann@gk.de

    Recruiting

  • Universitätsklinikum Leipzig

    Leipzig

    Simone Heyn, MD, Simone.Heyn@medizin.uni-leipzig.de

    Not yet recruiting

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck

    Nicolas von Bubnoff, MD, nikolas.vonBubnoff@uksh.de

    Recruiting

  • Klinikum rechts der Isar TU München

    München

    Lena Illert, MD, lena.illert@tum.de

    Not yet recruiting

  • Universitätsklinikum Münster

    Münster

    Andrea Kerkhoff, MD, andrea.kerkhoff@ukmuenster.de

    Recruiting

  • Universitätsklinik der Paracelsus Medizinischen Privatuniversität

    Nuremberg

    Alexander Bott, MD, alexander.bott@klinikum-nuernberg.de

    Not yet recruiting

  • Pius-Hospital Oldenburg

    Oldenburg

    Johannes Hoffmann, MD, johannes.hoffmann@pius-hospital.de

    Recruiting

  • Klinikum Oldenburg gGmbh

    Oldenburg in Holstein

    Christoph Kimmich, MD, kimmich.christoph@klinikum-oldenburg.de

    Not yet recruiting

  • Universitätsklinikum Regensburg

    Regensburg

    Florian Lüle, MD, Florian.Lueke@klinik.uni-regensburg.de

    Recruiting

  • Universitätsmedizin Rostock

    Rostock

    Christoph Wittke, MD, christoph.wittke@med.uni-rostock.de

    Not yet recruiting

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

    Stuttgart, Baden-Wurttemberg, 70174

    Gerald Illerhaus, PhD, +49 711 278 ext. 30400, G.Illerhaus@klinikum-stuttgart.de

    Julia Wendler, MD, j.wendler@klinikum-stuttgart.de

    Recruiting

  • Universtitätsklinikum Tübingen

    Tübingen

    Robert Möhle, MD, robert.moehle@med.uni-tuebingen.de

    Not yet recruiting

  • Universitätsklinikum Ulm

    Ulm

    Andreas Viardot, MD, andreas.viardot@uniklinik-ulm.de

    Recruiting

  • Schwarzwald-Baar-Klinikum Villingen-Schwenningen

    Villingen-Schwenningen

    Paul La Rosée, MD, paul.laRosee@sbk-vs.de

    Recruiting

Other trials in Germany

About this study

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

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.

Read the detailed description

Primary diffuse large B-cell lymphoma of the central nervous system (PCNSL) is a rare lymphoma affecting only the central nervous system compartment. PCNSL patients are typically 60 years or older and have poor prognoses. However, there are alternative treatment approaches to consider with the potential to improve medical outcomes for this patient population. The current standard of care in Germany and many international centres for patients 65 and older is treatment with R-MP, comprising rituximab, high-dose methotrexate (HD-MTX) and procarbazine followed by maintenance therapy with procarbazine. An alternative approach comprised of a shorter induction treatment with rituximab, HD-MTX and cytarabine (MARTA) followed by age-adjusted high-dose chemotherapy and autologous stem cell transplantation (HCT-ASCT) was recently shown to be feasible and effective in elderly PCNSL patients considered eligible for high-dose chemotherapy requiring autologous stem cell transplantation. Nevertheless, data evaluating this short duration treatment approach remains scarce, and randomized trials have not yet been published. The objective of the PRIMA-CNS trial is to demonstrate that intensified chemotherapy followed by consolidating HCT-ASCT is superior to conventional chemotherapy with R-MP followed by maintenance with procarbazine in elderly patients with newly diagnosed PCNSL; not only regarding survival and remission after treatment but also regarding standards like quality of life (QOL) and treatment related morbidities. Results of this randomized trial will either change the standard of care to an intense and shorter treatment approach or re-define R-MP as a proven treatment standard. In addition, a geriatric assessement is implemented in this trial with the goal to better define transplant eligibility. If this trial shows the superiority of HCT-ASCT, the investigators will establish an improved treatment standard with increased chances for long-term remission and cure and reduced frequency and length of chemotherapy treatment. Considering the poor prognosis of this patient population, this randomized phase III trial is of great clinical importance to provide patients, the patients' families and care takers with optimal treatment.

Being tested
R-MP and Procarbazine maintenance, R-MTX/AraC (MARTA) induction followed by consolidating HCT-ASCT
Keywords
Primary central nervous system lymphoma, HD-chemotherapy followed by autologous stem cell transplantation, Age-adjusted HCT-ASCT, First-line treatment in elderly PCNSL patients, HD-MTX induction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • R-MP and Procarbazine maintenanceDrug

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

  • R-MTX/AraC (MARTA) induction followed by consolidating HCT-ASCTDrug

    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

Study groups in NCT06830421
Study groupRoleWhat they receive
Arm AActive comparatorPatients will receive 3 cycles (28 days cycle) of R-MP (Rituximab 375 mg/m² i.v. d0,14; MTX 3.5 g/m² i.v. d1,15; Procarbazine 60 mg/m²/d p.o. d2-11) followed by maintenance therapy with Procarbazine 100 mg absolute/d p.o. d1-5 for additional 6 cycles (28 days cycle).
Receives: Drug: R-MP and Procarbazine maintenance
Arm BExperimentalPatients will receive 2 cycles (21 days cycle) of R-MTX/AraC (Rituximab 375 mg/m² i.v. d0,4; MTX 3.5 g/m² i.v. d1; AraC 2x2 g/m² i.v. d2+d3) followed by consolidating HCT-ASCT with Rituximab 375 mg/m² d-8, Busulfan 3.2 mg/kg/d i.v. d-7 and d-6 and Thiotepa 5 mg/kg/d i.v. d-5 and d-4.
Receives: Drug: R-MTX/AraC (MARTA) induction followed by consolidating HCT-ASCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS) between the 2 arms

    PFS is defined as the time from randomization to disease progression or death of any cause, with censoring at the last date the patient was seen alive and free of disease progression

    Measured: up to 6 years

Secondary outcomes (7)

  1. Overall survival (OS) between the 2 arms

    OS is defined as time from randomization until death from any cause, with censoring at the last date the patient was seen alive

    Measured: up to 6 years

  2. Event free survival (EFS) between the 2 arms

    EFS, defined as time from randomization to premature end of treatment (EOT) due to any reason, lymphoma progression or death, whichever occurs first, with censoring at the last date the patient was seen event-free

    Measured: up to 6 years

  3. Remission status after 2 cycles of rituximab-methotrexate-procarbazine (R-MP) (arm A)/2 cycles of R-MTX/cytarabine (AraC)

    Remission status after 2 cycles of RMP (arm A) / 2 cycles of R-MTX/AraC will be determined at response assessment (RA) I in both arms and will be divided in complete remission (CR), unconfirmed complete remission (CRu), partial remission (PR), stable disease (SD), progressive disease(PD) according to international PCNSL collaborative group (IPCG) criteria

    Measured: at RA I: after 8 weeks (Arm A), after 6 weeks (Arm B)

  4. Remission status after 3 cycles of R-MP (arm A)/consolidating HCT-ASCT (arm B)

    determined at response assessment (RA) II and will be divided in CR, CRu, PR, SD, PD according to IPCG criteria

    Measured: at RA II: after 12 weeks

  5. Remission status after completion of maintenance treatment (arm A)/6 months follow-up (arm B)

    will be determined 6 months after RA II and will be divided in CR, CRu, PR, SD, PD according to IPCG criteria

    Measured: 6 months after RA II

  6. Quality of life (EORTC QLQ-C30)

    EORTC quality of life questionnaire (QLQ)-C30 performed at screening, at RA II /premature EOT and thereafter every 12 months during follow-up

    Measured: from date of informed consent form (ICF) signature up to 6 years

  7. Quality of Life (EORTC-QLQ BN 20)

    EORTC-QLQ brain neoplasm (BN) 20, performed at screening, at RA II /premature EOT and thereafter every 12 months during follow-up

    Measured: from date of informed consent form (ICF) signature up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2025
  2. Study start9 Aug 2023
  3. Primary completion31 Aug 2029 (estimated)
  4. Study completion31 Aug 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized, controlled, open-label, multicenter phase III trial with 2 parallel arms investigating a more intensive, shorter treatment with 2 cycles of MARTA (rituximab, HD-MTX, AraC) followed by HCT with rituximab, busulfan and thiotepa followed by ASCT compared to standard therapy comprising 3 cycles of R-MP followed by procarbazine maintenance for 6 months.
Masking
None (open label)
Enrolment
340 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06830421
Sponsor's protocol ID
P003077
Other IDs
2020-001181-10, DRKS00024085
Acronym
PRIMA-CNS
Status last verified
Oct 2024
First submitted
5 Jun 2023
Last updated
17 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Publication of study protocol and publication of study results

Publications

  • Schorb E, Isbell LK, Kerkhoff A, Mathas S, Braulke F, Egerer G, Roth A, Schliffke S, Borchmann P, Brunnberg U, Kroschinsky F, Mohle R, Rank A, Wellnitz D, Kasenda B, Pospiech L, Wendler J, Scherer F, Deckert M, Henkes E, von Gottberg P, Gmehlin D, Backenstrass M, Jensch A, Burger-Martin E, Grishina O, Fricker H, Malenica N, Orban A, Duyster J, Ihorst G, Finke J, Illerhaus G. High-dose chemotherapy and autologous haematopoietic stem-cell transplantation in older, fit patients with primary diffuse large B-cell CNS lymphoma (MARTA): a single-arm, phase 2 trial. Lancet Haematol. 2024 Mar;11(3):e196-e205. doi: 10.1016/S2352-3026(23)00371-X. Epub 2024 Jan 29.

    PubMed 38301670

  • Mendez JS, Ostrom QT, Gittleman H, Kruchko C, DeAngelis LM, Barnholtz-Sloan JS, Grommes C. The elderly left behind-changes in survival trends of primary central nervous system lymphoma over the past 4 decades. Neuro Oncol. 2018 Apr 9;20(5):687-694. doi: 10.1093/neuonc/nox187.

    PubMed 29036697

  • Houillier C, Soussain C, Ghesquieres H, Soubeyran P, Chinot O, Taillandier L, Lamy T, Choquet S, Ahle G, Damaj G, Agape P, Molucon-Chabrot C, Amiel A, Delwail V, Fabbro M, Jardin F, Chauchet A, Moles-Moreau MP, Morschhauser F, Casasnovas O, Gressin R, Fornecker LM, Abraham J, Marolleau JP, Tempescul A, Campello C, Colin P, Tamburini J, Laribi K, Serrier C, Haioun C, Chebrek S, Schmitt A, Blonski M, Houot R, Boyle E, Bay JO, Oberic L, Tabouret E, Waultier A, Martin-Duverneuil N, Touitou V, Cassoux N, Kas A, Mokhtari K, Charlotte F, Alentorn A, Feuvret L, Le Garff-Tavernier M, Costopoulos M, Mathon B, Peyre M, Delgadillo D, Douzane H, Genet D, Aidaoui B, Hoang-Xuan K, Gyan E. Management and outcome of primary CNS lymphoma in the modern era: An LOC network study. Neurology. 2020 Mar 10;94(10):e1027-e1039. doi: 10.1212/WNL.0000000000008900. Epub 2020 Jan 6.

    PubMed 31907289

  • Schorb E, Fox CP, Kasenda B, Linton K, Martinez-Calle N, Calimeri T, Ninkovic S, Eyre TA, Cummin T, Smith J, Yallop D, De Marco B, Krampera M, Trefz S, Orsucci L, Fabbri A, Illerhaus G, Cwynarski K, Ferreri AJM. Induction therapy with the MATRix regimen in patients with newly diagnosed primary diffuse large B-cell lymphoma of the central nervous system - an international study of feasibility and efficacy in routine clinical practice. Br J Haematol. 2020 Jun;189(5):879-887. doi: 10.1111/bjh.16451. Epub 2020 Jan 29.

    PubMed 31997308

  • Olivier G, Clavert A, Lacotte-Thierry L, Gardembas M, Escoffre-Barbe M, Brion A, Cumin I, Legouffe E, Solal-Celigny P, Chabin M, Ingrand P, Colombat P, Delwail V. A phase 1 dose escalation study of idarubicin combined with methotrexate, vindesine, and prednisolone for untreated elderly patients with primary central nervous system lymphoma. The GOELAMS LCP 99 trial. Am J Hematol. 2014 Nov;89(11):1024-9. doi: 10.1002/ajh.23812. Epub 2014 Aug 27.

    PubMed 25052698

  • Ferreri AJ, Cwynarski K, Pulczynski E, Ponzoni M, Deckert M, Politi LS, Torri V, Fox CP, Rosee PL, Schorb E, Ambrosetti A, Roth A, Hemmaway C, Ferrari A, Linton KM, Ruda R, Binder M, Pukrop T, Balzarotti M, Fabbri A, Johnson P, Gorlov JS, Hess G, Panse J, Pisani F, Tucci A, Stilgenbauer S, Hertenstein B, Keller U, Krause SW, Levis A, Schmoll HJ, Cavalli F, Finke J, Reni M, Zucca E, Illerhaus G; International Extranodal Lymphoma Study Group (IELSG). Chemoimmunotherapy with methotrexate, cytarabine, thiotepa, and rituximab (MATRix regimen) in patients with primary CNS lymphoma: results of the first randomisation of the International Extranodal Lymphoma Study Group-32 (IELSG32) phase 2 trial. Lancet Haematol. 2016 May;3(5):e217-27. doi: 10.1016/S2352-3026(16)00036-3. Epub 2016 Apr 6.

    PubMed 27132696

  • Ferreri AJM, Cwynarski K, Pulczynski E, Fox CP, Schorb E, La Rosee P, Binder M, Fabbri A, Torri V, Minacapelli E, Falautano M, Ilariucci F, Ambrosetti A, Roth A, Hemmaway C, Johnson P, Linton KM, Pukrop T, Sonderskov Gorlov J, Balzarotti M, Hess G, Keller U, Stilgenbauer S, Panse J, Tucci A, Orsucci L, Pisani F, Levis A, Krause SW, Schmoll HJ, Hertenstein B, Rummel M, Smith J, Pfreundschuh M, Cabras G, Angrilli F, Ponzoni M, Deckert M, Politi LS, Finke J, Reni M, Cavalli F, Zucca E, Illerhaus G; International Extranodal Lymphoma Study Group (IELSG). Whole-brain radiotherapy or autologous stem-cell transplantation as consolidation strategies after high-dose methotrexate-based chemoimmunotherapy in patients with primary CNS lymphoma: results of the second randomisation of the International Extranodal Lymphoma Study Group-32 phase 2 trial. Lancet Haematol. 2017 Nov;4(11):e510-e523. doi: 10.1016/S2352-3026(17)30174-6. Epub 2017 Oct 17.

    PubMed 29054815

  • Fritsch K, Kasenda B, Schorb E, Hau P, Bloehdorn J, Mohle R, Low S, Binder M, Atta J, Keller U, Wolf HH, Krause SW, Hess G, Naumann R, Sasse S, Hirt C, Lamprecht M, Martens U, Morgner A, Panse J, Frickhofen N, Roth A, Hader C, Deckert M, Fricker H, Ihorst G, Finke J, Illerhaus G. High-dose methotrexate-based immuno-chemotherapy for elderly primary CNS lymphoma patients (PRIMAIN study). Leukemia. 2017 Apr;31(4):846-852. doi: 10.1038/leu.2016.334. Epub 2016 Nov 15.

    PubMed 27843136

  • Schorb E, Kasenda B, Ihorst G, Scherer F, Wendler J, Isbell L, Fricker H, Finke J, Illerhaus G. High-dose chemotherapy and autologous stem cell transplant in elderly patients with primary CNS lymphoma: a pilot study. Blood Adv. 2020 Jul 28;4(14):3378-3381. doi: 10.1182/bloodadvances.2020002064.

    PubMed 32722778

  • Schorb E, Finke J, Ihorst G, Kasenda B, Fricker H, Illerhaus G. Age-adjusted high-dose chemotherapy and autologous stem cell transplant in elderly and fit primary CNS lymphoma patients. BMC Cancer. 2019 Mar 29;19(1):287. doi: 10.1186/s12885-019-5473-z.

    PubMed 30925912

  • Omuro A, Chinot O, Taillandier L, Ghesquieres H, Soussain C, Delwail V, Lamy T, Gressin R, Choquet S, Soubeyran P, Huchet A, Benouaich-Amiel A, Lebouvier-Sadot S, Gyan E, Touitou V, Barrie M, del Rio MS, Gonzalez-Aguilar A, Houillier C, Delgadillo D, Lacomblez L, Tanguy ML, Hoang-Xuan K. Methotrexate and temozolomide versus methotrexate, procarbazine, vincristine, and cytarabine for primary CNS lymphoma in an elderly population: an intergroup ANOCEF-GOELAMS randomised phase 2 trial. Lancet Haematol. 2015 Jun;2(6):e251-9. doi: 10.1016/S2352-3026(15)00074-5. Epub 2015 Jun 3.

    PubMed 26688235

  • Wendler J, Fox CP, Valk E, Steinheber C, Fricker H, Isbell LK, Neumaier S, Okosun J, Scherer F, Ihorst G, Cwynarski K, Schorb E, Illerhaus G. Optimizing MATRix as remission induction in PCNSL: de-escalated induction treatment in newly diagnosed primary CNS lymphoma. BMC Cancer. 2022 Sep 10;22(1):971. doi: 10.1186/s12885-022-09723-w.

    PubMed 36088292

  • Farhi J, Laribi K, Orvain C, Hamel JF, Mercier M, Sutra Del Galy A, Clavert A, Rousselet MC, Tanguy-Schmidt A, Hunault-Berger M, Moles-Moreau MP. Impact of front line relative dose intensity for methotrexate and comorbidities in immunocompetent elderly patients with primary central nervous system lymphoma. Ann Hematol. 2018 Dec;97(12):2391-2401. doi: 10.1007/s00277-018-3468-5. Epub 2018 Aug 8.

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  • Martinez-Calle N, Isbell LK, Cwynarski K, Schorb E. Advances in treatment of elderly primary central nervous system lymphoma. Br J Haematol. 2022 Feb;196(3):473-487. doi: 10.1111/bjh.17799. Epub 2021 Aug 26.

    PubMed 34448202

  • Schorb E, Isbell LK, Illerhaus G, Ihorst G, Meerpohl JJ, Grummich K, Nagavci B, Schmucker C. Treatment Regimens for Immunocompetent Elderly Patients with Primary Central Nervous System Lymphoma: A Scoping Review. Cancers (Basel). 2021 Aug 24;13(17):4268. doi: 10.3390/cancers13174268.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing R-MP and Procarbazine maintenance and R-MTX/AraC (MARTA) induction followed by consolidating HCT-ASCT in people with Primary Central Nervous System Lymphoma, run by University Hospital Freiburg at 35 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elisabeth Schorb, MD (+49 761 270-35360, elisabeth.schorb@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) between the 2 arms (time frame: up to 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06830421, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.

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