Clinical Trial Details
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[Information provided by:, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01011920 : Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
PhasePhase 2
AgesMin: 18 Years Max: 65 Years
Inclusion Criteria:

- Histological or cytological assessed diagnosis of non-Hodgkin's lymphoma.

- Diagnostic sample obtained by stereotactic or surgical biopsy, Cerebrospinal Fluid
(CSF) cytology examination or vitrectomy.

- Disease exclusively localized into the central nervous system, CSF, cranial nerves or

- At least one measurable lesion.

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

- Age 18-65 years (with ECOG Performance Status 0-3) or 66-70 (with ECOG Performance
Status 0-2).

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

- Sexually active patients of childbearing potential agreeing in implementing adequate
contraceptive measures during study participation.

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

- Patient-signed informed consent obtained before registration.

Exclusion Criteria:

- Patients with lymphomatous lesions outside the CNS.

- Patients with a previous non-Hodgkin lymphoma at any time.

- 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 from 5 years.

- HBsAg and HCV positivity.

- HIV infection, previous organ transplantation or other clinically evident form of

- Concurrent treatment with other experimental drugs.

- Concurrent Pregnancy or lactation.

- Patients not agreeing to take adequate contraceptive measures during the study.

- Symptomatic coronary artery disease, cardiac arrhythmias uncontrolled with medication
or myocardial infarction within the last 6 months (New York Heart Association Class
III or IV heart disease).
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