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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT02428751
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed diagnosis of CD20-positive diffuse large B-cell lymphoma
* 60\~80 years old
* Ann Arbor stage I\~IV
* ECOG physical score of 0\~2
* Have not received previous treatment to lymphoma, including chemotherapy, radiotherapy, or biotherapy
* Have at least one clinically measurable lesion: \>= 2cm under physical examination, or \>= 1.5cm under computed tomography (CT) or magnetic resonance (MR)
* Life expectancy of \>= 3 months
* Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase and total bilirubin \<= 2 × upper limit of normal (ULN)
* Glomerular filtration rate (MDRD method) \>= 30ml/min
* No abnormalities in blood coagulative function
* Generally normal bone marrow function: while blood cell \>= 3,000/μL, absolute neutrophil count \>= 1,500/μL, hemoglobin \>= 100g/L, platelet \>= 75,000/μL
* No evidence of active hepatitis B or C virus, or human immunodeficiency virus infection
* Left ventricular ejection fraction (LVEF) \>= 45% measured by two dimensional echocardiography or multi-gated acquisition (MUGA) scan
* Cardiac function of class I-II in New York Heart Association (NYHA) classification
Exclusion Criteria:
* Patients with indolent lymphoma
* Positive results for in situ hybridization for Epstein-Barr virus encoded RNA (EBER)
* Serum Epstein-Barr virus DNA \>= 1,000 copies/ml
* Double-hit lymphoma confirmed by fluorescence in situ hybridization (FISH)
* Primary mediastinal B-cell lymphoma
* Involvement of central nervous system
* Bulky disease (\>= 10cm)
* History of cardiac disease, including clinically significant ventricular tachycardia, atrial fibrillation, conduction block, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease which needs medication
* Known allergic reaction to any component of the agents used in the chemotherapeutic regimens that are used in the study
* Previous exposure to anthracycline drugs, rituximab, or chemotherapy for lymphoma
* History of malignant carcinoma within 5 years (except carcinoma in situ of the skin and uterine cervix, and prostatic carcinoma)
* Currently enrolled in other clinical studies
* Other conditions that the investigators consider as inappropriate for enrolling into this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
80 Years
Study:
NCT02428751
Study Brief:
Protocol Section:
NCT02428751