Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT01011920
Eligibility Criteria:
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 eyes.
* 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 immunodeficiency.
* 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01011920
Study Brief:
Protocol Section:
NCT01011920