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.
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.
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.
University Hospital Freiburg
Lead sponsor
German Federal Ministry of Education and Research
Collaborator
University Hospital Tuebingen
Collaborator
Heinrich-Heine University, Duesseldorf
Collaborator
Klinikum Stuttgart
Collaborator
University of Kaiserslautern
Collaborator
University Hospital Munich
Collaborator
University Hospital Regensburg
Collaborator