Klinische Studie zur individuellen Behandlung von älteren Patienten mit neu diagnostiziertem primärem Lymphom des zentralen Nervensystems

Drug: Rituximab;Drug: Methotrexate;Drug: Procarbazine;Drug: Lenalidomide;Radiation: Radiotherapy;Drug: Temozolomide

Gender: All
Maximum age: N/A
Minimum age: 70 Years

Inclusion Criteria:

- Histologically or cytologically assessed diagnosis of CD20+ diffuse large B-cell
lymphoma.

- Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology
examination or vitrectomy.

- Lymphoma exclusively localized in the central nervous system (brain parenchyma and/or
meningeal/CSF dissemination and/or eyes and/or cranial nerves).

- Previously untreated patients (previous or ongoing steroid therapy admitted).

- Age =70 years

- Patients not eligible for high-dose chemotherapy supported by autologous stem cell
transplant

- ECOG PS =3.

- Adequate bone marrow, cardiac, renal, and hepatic function

- No previous or concurrent malignancies with the exception of surgically cured
carcinoma in-situ of the cervix, carcinoma of the skin or other cancers without
evidence of disease at least for 3 years (patients with a previous lymphoma at any
time are NOT eligible).

- Absence of any familial, sociological or geographical condition potentially hampering
compliance with the study protocol and follow-up schedule.

- No concurrent treatment with other experimental drugs.

- Patients receiving oral lenalidomide or procarbazine must agree to avoid sharing the
study medication with another person and to return all unused study drug to the
investigator.

- Male patients must agree to always use a latex or synthetic condom during any sexual
contact with females of reproductive potential while taking lenalidomide, during dose
interruptions and for up to 7 days after treatment discontinuation, even if they have
undergone a successful vasectomy.

- Informed consent from the patient, or legal representative, obtained before
registration.

Exclusion Criteria:

- Lymphoma entity other than diffuse large B-cell lymphoma.

- Extra-CNS disease.

- Lymphoma exclusively localized in the eyes

- Lymphoma infiltration of the cranial nerves as exclusive site of disease

- Previous antineoplastic treatment for the PCNSL.

- Patients eligible for ASCT.

- HBsAg- and HCV-positive patients; HBsAg- and HCV-positive patients. HBcAb+ is not
exclusion criteria in the absence of detectable levels HBVDNA.

- HIV disease or immunodeficiency.

- Severe concomitant illnesses/medical conditions (e.g. impaired respiratory and/or
cardiac function, uncontrolled diabetes mellitus despite optimal medical management).

- Active infectious disease.

- Hypersensitivity to any active principle and/or any excipient according to the
contraindications reported in the Summary of Product Characteristics (SmPCs) of the
anticancer drugs used in the study