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:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
NCT ID:
NCT00210366
Eligibility Criteria:
Inclusion Criteria:
* Histological or cytological diagnosis of non-Hodgkin's lymphoma
* Disease exclusively localised into the CNS at first diagnosis and failure
* Progressive or recurrent disease
* Previous treatment with HDMTX containing CHT and/or RT
* Presence of at least one target lesion, bidimensionally measurable
* Age 18 - 75 years
* ECOG performance status \< 3 (Appendix 1).
* No known HIV disease or immunodeficiency
* HBsAg-negative and Ab anti-HCV-negative patients.
* Adequate bone marrow function (plt \> 100000 mm3, Hb \> 9 g/dl, ANC \> 2.000 mm3)
* Adequate renal function (serum creatinine \< 2 times UNL)
* Adequate hepatic function (SGOT/SGPT \< 3 times UNL, bilirubin and alkaline phosphatase \< 2 times UNL)
* Adequate cardiac function (VEF ≥ 50%)
* Absence of any psycological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Non-pregnant and non-lactating status for female patients. Adequate contraceptive measures during study participation for sexually active patients of childbearing potential.
* No previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin and of other neoplasms without evidence of disease since at least 5 years.
* No concurrent treatment with other experimental drugs.
* Informed consent signed by the patient before registration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00210366
Study Brief:
Protocol Section:
NCT00210366