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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT03495960
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT03495960
Study Brief:
Protocol Section:
NCT03495960