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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT01178658
Eligibility Criteria:
Inclusion Criteria:
* Patients with a high-intermediate/high risk international prognostic index at a diagnosis or with salvage chemotherapy-sensitive relapse/refractory non-Hodgkin lymphoma
* Patients with histologically confirmed T cell or NK cell lymphoma at diagnosis
* Patients who have not received therapy with high-dose chemotherapy and stem cell transplantation
* Life expectation of at least 3 months
* ECOG performance status ≤ 2
* Adequate hepatic function (serum bilirubin less than 2.0 mg/dL, AST and ALT less than three times the upper normal limit)
* Adequate renal function (serum creatinine less than 2.0 mg/dL).
* Adequate cardiac function (ejection fraction ≥ 45% on MUGA scan or echocardiogram).
* Adequate bone marrow function (ANC ≥ 1,000/mm3 and platelet count ≥ 75,000/mm3).
* All patients are fully informed about the nature and purpose of this study and informed consent should be given before the start of treatment. All patients should fully understand the right of trial abandon without any disadvantage
Exclusion Criteria:
* Patients with central nervous system involvement of lymphoma
* Patients positive for human immunodeficiency virus
* Pregnant or breast feeding woman
* Young woman without pregnancy test prior to treatment or pregnancy test reveals positive.
* Young woman without a reliable and proper contraceptive method
* Man being not willing to contraception
* Concurrent history of neoplasm other than non-Hodgkin lymphoma with life expectancy less than 3 months (except for curatively treated non-melanoma skin cancer or in-situ uterine cervix cancer).
* History of clinically significant cardiac dysfunction (e.g. congestive heart failure, symptomatic coronary artery disease, medically uncontrolled arrhythmia) or myocardial infarction within 12 months
* A psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible.
* Significant infection or uncontrolled bleeding
* Enrollment of other clinical trials within 4 weeks prior to treatment
* Any preexisting medical condition of sufficient severity to prevent full compliance with the study
* Patient being not willing to or unable to obey study protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
65 Years
Study:
NCT01178658
Study Brief:
Protocol Section:
NCT01178658