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 @ 3:00 PM
Ignite Modification Date:
2025-12-24 @ 3:00 PM
NCT ID:
NCT01238159
Eligibility Criteria:
Inclusion Criteria:
* patients were required to have a biopsy-proven diagnosis of nasal ENKTL
* at least 18 years old
* Ann Arbor stage IE or IIE
* measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 life expectancy greater than 12 weeks
* adequate hematologic (hemoglobin \> 9.0 g/dL, absolute neutrophil count \> 1,500/uL and platelets \> 100,000/uL)
* renal (serum creatinine \< 1.5 mg/dL, creatinine clearance \> 50 mL/min)
* hepatic (total bilirubin \< 2 times of upper limit of normal and aspartate transferase \< 3 times of upper limit of normal) function
* Diagnosis of ENKTL is based on the presence of histological features and immunophenotypes compatible with ENKTL (e.g., cytoplasmic CD3+, CD20-, CD56+,
* positive for cytotoxic molecules
* positive for EBV by in situ hybridization).
* Informed consent
Exclusion Criteria:
* prior or concomitant malignant tumors
* any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.
* ENKTL with non-nasal sites such as skin or gastrointestinal tract was excluded even if it is localized.
* Other subtypes of non-Hodgkin lymphoma (NHL), including myeloid/NK cell precursor acute leukemia, blastic NK cell lymphoma/precursor NK cell lymphoblastic leukemia, aggressive NK cell leukemia, and peripheral T cell lymphoma, unspecified, were excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01238159
Study Brief:
Protocol Section:
NCT01238159