Primary central nervous system lymphoma (PCNSL) is an aggressive Non-Hodgkin Lymphoma (NHL) mostly of B-cell origin, which exclusively invades the central nervous system compartment. It accounts for 3% to 4% of all primary brain tumours and 4% to 6% of extra-nodal lymphomas. The incidence of PCNSL in immunocompetent patients has been steadily increasing over the last 30 years. Patients older than 60 years account for more than 50% of all PCNSL cases.
Conditions
Sponsors
Medical Center - University of Freiburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Immunocompetent patients with newly-diagnosed primary central nervous system B-cell lymphoma. 2. Age > 65 years not eligible for treatment within the MATRix/IELSG43 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 one measurable lesion. 7. ECOG-Performance Status = 2. 8. Patients eligible for intensive treatment according to physician´s choice. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 51
Exclusion criteria
Exclusion criteria: 1. Congenital or acquired immunodeficiency. 2. Systemic lymphoma manifestation (outside the CNS). 3. Isolated ocular lymphoma without manifestation in the brain parenchyma or spinal cord. 4. Previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix, carcinoma of the skin 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 500 ml. 12. Hypersensitivity to study treatment or any component of the formulation. 13. Taking any medications likely to cause interactions with the study medication. 14. Known or persistent abuse of medication, drugs or alcohol. 15. Patient without legal capacity and who is unable to understand the nature, significance and consequences of the study and without designated legal representative. 16. Persons who are in a relationship of dependency/employment to the sponsor and/ or investigator. 17. Any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to investigate the efficacy of age-adapted induction treatment followed by high-dose chemotherapy and autologous stem cell transplantation regarding 1-year PFS in elderly and fit patients with primary CNS lymphoma.;Secondary Objective: Secondary objectives are the investigation of OS, treatment response (rate of complete responses on day 30 after HDT-ASCT) and treatment related morbidities (neurotoxicity and adverse advents).;Primary end point(s): Primary endpoint: progression free survival (PFS) at 1 year;Timepoint(s) of evaluation of this end point: Time from start of treatment until disease progression or death from any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoint(s): • Rate of complete responses (CR) • Progression-free survival (PFS) • Overall survival (OS) • Rate of neurotoxicity • Non relapse mortality (NRM) • (Serious) adverse events ([S]AEs) • Toxicity ;Timepoint(s) of evaluation of this end point: CR: on day +30 after HDT-ASCT PFS: as time from start of treatment until progression, relapse or death from any cause, whatever happens first OS: as time from start of treatment until death from any cause Rate of Neurotoxocity: on day + 30 after HDT-ASCT and continuously thereafter Non relapse mortality (NRM): coutinously SAEs: from the first administration of the study medication until day 30 after HDT-ASCT Toxicity: continously | — |
Countries
Germany
Contacts
Public ContactDr. med. Elisabeth Schorb
Universitätsklinikum Freiburg, Abt. Med I
Outcome results
None listed