Last updated: March 7, 2023
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Overall Status: Active - Not Recruiting
Phase
2
Condition
Non-hodgkin's Lymphoma
Lymphoma
Treatment
N/AClinical Study ID
NCT05774028
2023-SR-002
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Voluntarily join this study and sign the informed consent form; 2. 18 years old ≤age ≤ 75 years old; 3. Expected survival time ≥ 3 months; 4. Histopathologicallyconfirmed early non-upper aerodigestive or advanced 5. There must be at least oneevaluable or measurable lesion that meets the Lugano2014 criteria: lymph node lesions,measurable lymph nodes need to have a long diameter > 1.5cm; non-lymph node lesions,extranodal lesions that can be measured Long diameter > 1.0cm; 6. ECOG score 0-2points; 7. Bone marrow function: neutrophil count ≥ 1.5×109/L, platelet count ≥ 75×109/L, hemoglobin ≥ 80g/L; 8. Liver and kidney function: serum creatinine ≤ 1.5times the upper limit of the normal value; alanine aminotransferase (AST) andaspartate aminotransferase (ALT) ≤ 2.5 times the upper limit of the normal value (forpatients with liver invasion ≤ 5 times the normal value upper limit); total bilirubin ≤ 1.5 times the upper limit of normal value (for patients with liver invasion ≤ 3times the upper limit of normal value).
Exclusion
Exclusion Criteria:
- Hypersensitivity to any study drug or its components; 2. Uncontrollable systemicdiseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.); 3.Cardiac function and disease meet one of the following conditions :
- long QTc syndrome or QTc interval >480 ms;
- complete left bundle branch block, second-degree or third-degree atrioventricularblock;
- severe, uncontrolled arrhythmia requiring drug treatment ;
- New York Society of Cardiology ≥ Grade III;
- Cardiac ejection fraction (LVEF) lower than 50%;
- Myocardial infarction, unstable angina, and severely unstable ventricular rhythmwithin 6 months before recruitment History of arrhythmia or any other arrhythmiarequiring treatment, history of clinically severe pericardial disease, or ECGevidence of acute ischemia or active conduction system abnormalities.
- Active hepatitis B and C infection (positive hepatitis B virus surface antigenand more than 1x103 copies/mL of hepatitis B virus DNA; more than 1x103 copies/mLof hepatitis C virus RNA); 5. Human immunodeficiency virus (HIV) infection (positive HIV antibody); 6. Previously or currently suffering from othermalignant tumors (except for effectively controlled non-melanoma skin basal cellcarcinoma, breast/cervix carcinoma in situ and other malignant tumors that havebeen effectively controlled without treatment in the past five years); 7. Centralnervous system (CNS) involvement at the time of recruitment; 8. Pregnant,lactating women and patients of childbearing age who do not want to takecontraceptive measures; Other investigators judge that they are not suitable forparticipating in this study.
Study Design
Total Participants: 50
Study Start date:
April 01, 2023
Estimated Completion Date:
April 30, 2025