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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT01985451
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed primary CNS lymphoma.
* ECOG (Eastern Cooperative Oncology Group) Performance status of 0-1.
* Positive cerebrospinal fluid (CSF) cytology or immunohistochemical diagnosis of CSF monoclonality with or without measurable intracranial disease.
* Measurable (greater than 1 cm in diameter) tumor by CT scan or MRI.
* Progressed during first-line chemotherapy and/or radiotherapy OR relapsed after initial successful treatment.
* No systemic lymphoma by CT scan of the chest, abdomen, and pelvis with contrast.
* No leptomeningeal lymphoma by lumbar puncture for CNS cytology/flow cytometry.
* No ocular lymphoma by slit lamp examination.
* Must have adequate organ function as defined by the protocol: Adequate renal function: serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 60 ml/min; Adequate hepatic function: bilirubin level ≤ 1.5 x ULN, ASAT \& ALST ≤ 1.5 x ULN.Adequate bone marrow reserves: neutrophil (ANC) count ≥ 1500 /mm\^3, platelet count ≥ 100,000 /mm\^3, hemoglobin ≥ 9 g/dl.
* Age \>/= 18 and \</= 75 years.
* Signed written informed consent prior to study entry.
Exclusion Criteria:
* Patients with human immunodeficiency virus seropositivity and systemic lymphoma manifestation.
* Serious uncontrolled concurrent illness.
* Previous brain radiotherapy, systemic chemotherapy.
* Concurrent chronic systemic immune therapy, targeted therapy not indicated in this study protocol.
* Any evidence of prior exposure to Hepatitis B virus.
* Unable to comprehend the study requirements or who are not likely to comply with the study parameters.
* Pregnant (confirmed by serum or urine β-HCG) or lactating.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT01985451
Study Brief:
Protocol Section:
NCT01985451