Diffuse Large B cell Lymphoma
Conditions
Interventions
Pola-ZRCHP group:Pola-ZRCHP
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age is between 18 and 75 years at the time of signing the informed consent form; 2.The tissue sample is histologically confirmed as non-GCB DLBCL, and CD20 is expressed; 3.No prior treatment has been received; 4.IPI score is 2-5 points; 5.ECOG performance status score is 0 or 1; 6.Expected survival is >= 6 months.; 7.At least one bidimensional measurable lesion exists (with the longest diameter > 1.5 cm as measured by CT or MRI); 8.Echocardiography (ECHO) shows a left ventricular ejection fraction (LVEF) >= 50%; 9.Adequate hematological function: within 7 days prior to the first treatment, hemoglobin >= 9.0 g/dL (without packed RBC transfusion), neutrophil count >= 1.0 × 10^9/L, and platelet count >= 75 × 10^9/L. 10. For female participants with fertility: agree to keep abstinence (prohibit heterosexual sex) or take contraceptive measures, and agree not to donate eggs. For male participants: agree to keep abstinence (prohibit heterosexual sexual intercourse) or use contraceptive methods, and agree not to donate sperm.
Exclusion criteria
Exclusion criteria: 1.Contraindication to any individual component of Pola-ZR-CHP; 2.Presence of active bacterial, viral, fungal, or other infections, or occurrence of a major infection within 4 weeks prior to the first treatment; 3.Suspected or latent tuberculosis; 4.Currently pregnant or breastfeeding, or planning to become pregnant during the study period; 5.History of confirmed progressive multifocal leukoencephalopathy (PML); 6.Current or previous history of central nervous system (CNS) lymphoma; 7.Presence of significant, uncontrolled comorbidities that may affect compliance or interpretation of results; 8.Severe or extensive cardiovascular disease (e.g., NYHA Class III/IV heart failure, myocardial infarction within the past 6 months, etc.); 9.Clinically significant liver disease (including active hepatitis, alcoholism, or cirrhosis); 10.Abnormal laboratory results: INR or PT > 1.5 × ULN, aPTT > 1.5 × ULN, AST/ALT >= 2.5 × ULN, total bilirubin >= 1.5 × ULN, creatinine clearance < 40 mL/min; 11.HBV DNA positive; HCV antibody positive and HCV RNA positive; 12. Any other disease, metabolic dysfunction, disease or condition reasonably suspected by physical examination results or clinical laboratory results as contraindications to the use of test drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year progression free survival (2-year PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Complete remission rate;Incidence and severity of adverse events;Event-Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactYi Xia
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed