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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT03318835
Eligibility Criteria:
Inclusion Criteria:
1. Age range ≥18 years old
2. Eastern Cooperative Oncology Group performance status 0 to 2;
3. Newly diagnosed, untreated, histological confirmed diffuse large B cell lymphoma, non-GCB subtype, and Myc≥40% as well as Bcl-2≥70% through immunohistochemistry；
4. Measurable disease was defined as at least one lesion ≥1.5 cm in length-diameter and ≥0.5 cm in short-diameter by CT.
5. Patients have written informed consent to participate in the study.
6. Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed on signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.
7. White blood cell ≥ 3.5×109/L, absolute neutrophil count ≥ 1.5×109/L，platelet ≥ 80×109/L，hemoglobin ≥ 90 g/L
8. total bilirubin \< 1.5×upper limit of normal(ULN), ALT and AST \< 1.5× ULN
9. serum creatine \<1.5×ULN, and creatinine clearance rate (CCR) ≥ 30 ml/min
Exclusion Criteria:
1. Presence of CNS involvement
2. Particular kind of DLBCL，such as primary mediastinal/thymic B-cell lymphoma, elderly EBV positive DLBCL, primary cutaneous large B lymphoma.
3. History of myocardial diseases, such as congenital heart disease, pericardial disease, heart failure, myocardial infarction, coronary heart disease, valvular heart disease, myocardosis, arrhythmia.
4. History of severe chronic cutaneous diseases.
5. History of allergic asthma or severe allergic diseases.
6. Uncontrolled hypertension and diabetes.
7. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
8. HIV, HCV, or syphilis infection；
9. Presence of active HBV infection（HBV-DNA≥104）；
10. Pregnant or lactating women
11. Previously received organ transplant
12. Having usage of Thalidomide；
13. History of deep vein thrombosis
14. Serious uncontrolled infection
15. Having contraindications to the use of large doses of hormone, such as uncontrolled hyperglycemia, gastric ulcer, mental disorder.
16. Severe neurol of mental illness, including dementia and epilepsy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03318835
Study Brief:
Protocol Section:
NCT03318835