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

NCT ID: NCT06830421

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-09
• Study Completion Date: 2031-08-31

Brief 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.

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.

Conditions

Primary Central Nervous System Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

Patients 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).

Group Type: ACTIVE_COMPARATOR

R-MP and Procarbazine maintenance

Intervention Type: DRUG

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

Arm B

Patients 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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

R-MP and Procarbazine maintenance

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

Intervention Type: DRUG

R-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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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, cerebrospinal fluid (CSF) cytology examination or vitrectomy.

5. Disease exclusively located in the CNS.

6. At least 1 measurable lesion.

7. Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) ≤ 2. ECOG PS > 2 accepted if due to PCNSL symptoms.

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 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.

2. No evidence of disease progression after pre-phase treatment.

Exclusion Criteria

1. 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 thirty days before the start of this study.

10. Third space fluid accumulation >500 ml.

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: collaborator

Klinikum Stuttgart

OTHER

Sponsor Role: collaborator

University of Kaiserslautern

OTHER

Sponsor Role: collaborator

University Hospital Munich

OTHER

Sponsor Role: collaborator

University Hospital Regensburg

OTHER

Sponsor Role: collaborator

University Hospital Freiburg

OTHER

Sponsor Role: lead

Responsible Party

Elisabeth Schorb

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status: RECRUITING

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

Stuttgart, Baden-Wurttemberg, Germany

Site Status: RECRUITING

University Hospital Aachen

Aachen, , Germany

Site Status: RECRUITING

University Hospital Augsburg

Augsburg, , Germany

Site Status: RECRUITING

Helios Klinikum Berlin-Buch

Berlin, , Germany

Site Status: NOT_YET_RECRUITING

University Hospital Berlin

Berlin, , Germany

Site Status: RECRUITING

Evangelisches Klinikum Bethel

Bielefeld, , Germany

Site Status: NOT_YET_RECRUITING

Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH

Bochum, , Germany

Site Status: RECRUITING

Städtisches Klinikum Braunschweig gGmbH

Braunschweig, , Germany

Site Status: RECRUITING

Klinikum Bremen-Mitte gGmbH

Bremen, , Germany

Site Status: RECRUITING

Klinikum Chemnitz gGmbH

Chemnitz, , Germany

Site Status: NOT_YET_RECRUITING

Universitätsklinikum Köln

Cologne, , Germany

Site Status: NOT_YET_RECRUITING

Carl Gustav Carus Universitätsklinikum Dresden

Dresden, , Germany

Site Status: RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Site Status: NOT_YET_RECRUITING

Universitätsklinikum Erlangen

Erlangen, , Germany

Site Status: RECRUITING

Universitätsklinikum Essen

Essen, , Germany

Site Status: NOT_YET_RECRUITING

Klinikum der Johann-Wolfgang-Goethe-Universität

Frankfurt, , Germany

Site Status: RECRUITING

Universitätsmedizin Göttingen Georg-August-Universität

Göttingen, , Germany

Site Status: NOT_YET_RECRUITING

Universitätsklinikum Halle (Saale)

Halle, , Germany

Site Status: NOT_YET_RECRUITING

Universitätsklinikum des Saarlandes Homburg

Homburg, , Germany

Site Status: RECRUITING

Städtisches Klinikum Karlsruhe

Karlsruhe, , Germany

Site Status: RECRUITING

Universitätsklinkum Schleswig-Holstein, Campus Kiel

Kiel, , Germany

Site Status: RECRUITING

Gemeinschaftsklinikum Mittelrhein gGmbH - Koblenz Ev. Stift St. Martin

Koblenz, , Germany

Site Status: RECRUITING

Universitätsklinikum Leipzig

Leipzig, , Germany

Site Status: NOT_YET_RECRUITING

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, , Germany

Site Status: RECRUITING

Klinikum rechts der Isar TU München

München, , Germany

Site Status: NOT_YET_RECRUITING

Universitätsklinikum Münster

Münster, , Germany

Site Status: RECRUITING

Universitätsklinik der Paracelsus Medizinischen Privatuniversität

Nuremberg, , Germany

Site Status: NOT_YET_RECRUITING

Pius-Hospital Oldenburg

Oldenburg, , Germany

Site Status: RECRUITING

Klinikum Oldenburg gGmbh

Oldenburg in Holstein, , Germany

Site Status: NOT_YET_RECRUITING

Universitätsklinikum Regensburg

Regensburg, , Germany

Site Status: RECRUITING

Universitätsmedizin Rostock

Rostock, , Germany

Site Status: NOT_YET_RECRUITING

Universtitätsklinikum Tübingen

Tübingen, , Germany

Site Status: NOT_YET_RECRUITING

Universitätsklinikum Ulm

Ulm, , Germany

Site Status: RECRUITING

Schwarzwald-Baar-Klinikum Villingen-Schwenningen

Villingen-Schwenningen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Elisabeth Schorb, MD

Role: CONTACT

elisabeth.schorb@uniklinik-freiburg.de

+49 761 270-35360

Gerald Illerhaus, MD

Role: CONTACT

g.illerhaus@klinikum-stuttgart.de

+49 711 278-30400

Facility Contacts

Elisabeth Schorb, MD

Role: primary

elisabeth.schorb@uniklinik-freiburg.de

+4976127035360

Lisa K Isbell, MD

Role: backup

lisa.isbell@uniklinik-freiburg.de

Gerald Illerhaus, PhD

Role: primary

G.Illerhaus@klinikum-stuttgart.de

+49 711 278 ext. 30400

Julia Wendler, MD

Role: backup

j.wendler@klinikum-stuttgart.de

Jens Panse, MD

Role: primary

jpanse@ukaachen.de

Mathias Lutz, MD

Role: primary

mathias.lutz@uk-augsburg.de

Christian Eimermacher, MD

Role: primary

Christian.eimermacher@helios-gesundheit.de

Ulrich Keller, MD

Role: primary

ulrich.keller@charite.de

Bettina Zinngrebe, MD

Role: primary

bettina.zinngrebe@evkb.de

Sabine Seidel, MD

Role: primary

Sabine.Seidel@kk-bochum.de

Carsten Springer, MD

Role: primary

c.springer@klinikum-braunschweig.de

Bernd Hertenstein, MD

Role: primary

bernd.hertenstein@klinikum-bremen-mitte.de

Mathias Hänel, MD

Role: primary

m.haenel@skc.de

Heger Jan-Michel, MD

Role: primary

jan-michel.heger@uk-koeln.de

Frank Kroschinsky, MD

Role: primary

frank.kroschinsky@uniklinikum-dresden.de

Guido Kobbe, MD

Role: primary

kobbe@med.uni-duesseldorf.de

Stefan Krause, MD

Role: primary

stefan.krause@uk-erlangen.de

Bastian von Tresckow, MD

Role: primary

bastian.vontresckow@uk-essen.de

Thomas Oellerich, MD

Role: primary

thomas.oellerich@kgu.de

Justin Hasenkamp, MD

Role: primary

j.hasenkamp@med.uni-goettingen.de

Thomas Weber, MD

Role: primary

thomas.weber@uk-halle.de

Lorenz Thurner, MD

Role: primary

lorenz.thurner@uks.eu

Martin Bentz, MD

Role: primary

martin.bentz@klinikum-karlsruhe.de

Christine Pott, MD

Role: primary

c.pott@med2.uni-kiel.de

Niemann Dirk, MD

Role: primary

Dirk.Niemann@gk.de

Simone Heyn, MD

Role: primary

Simone.Heyn@medizin.uni-leipzig.de

Nicolas von Bubnoff, MD

Role: primary

nikolas.vonBubnoff@uksh.de

Lena Illert, MD

Role: primary

lena.illert@tum.de

Andrea Kerkhoff, MD

Role: primary

andrea.kerkhoff@ukmuenster.de

Alexander Bott, MD

Role: primary

alexander.bott@klinikum-nuernberg.de

Johannes Hoffmann, MD

Role: primary

johannes.hoffmann@pius-hospital.de

Christoph Kimmich, MD

Role: primary

kimmich.christoph@klinikum-oldenburg.de

Florian Lüle, MD

Role: primary

Florian.Lueke@klinik.uni-regensburg.de

Christoph Wittke, MD

Role: primary

christoph.wittke@med.uni-rostock.de

Robert Möhle, MD

Role: primary

robert.moehle@med.uni-tuebingen.de

Andreas Viardot, MD

Role: primary

andreas.viardot@uniklinik-ulm.de

Paul La Rosée, MD

Role: primary

paul.laRosee@sbk-vs.de

References

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.

Reference Type: BACKGROUND

PMID: 38301670 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29036697 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31907289 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31997308 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25052698 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27132696 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29054815 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27843136 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32722778 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30925912 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26688235 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36088292 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30091022 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34448202 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34503078 (View on PubMed)

Other Identifiers

2020-001181-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DRKS00024085

Identifier Type: REGISTRY

Identifier Source: secondary_id

P003077

Identifier Type: -

Identifier Source: org_study_id