The Efficacy and Safety of ZR2 Versus R-CHOP-like Regimen for Elderly Patients With Newly Diagnosed Diffuse Large B Cell Lymphoma.

• Status: Recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, single-center, open-label clinical study designed to evaluate the efficacy and safety of the Zanubrutinib, Lenalidomide and Rituximab (ZR2) versus rituximab combined with CHOP or CDOP (R-CHOP or R-CDOP) in elderly patients with diffuse large B cell lymphoma treated for the first time.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University
• Treatments: Lenalidomide; Rituximab; Zanubrutinib

Criteria

Inclusion Criteria:

• Pathologically confirmed DLBCL

• Without treatment

• ≥ 65 years old

• Measurable lesions on CT or PET-CT before treatment

• Life expectancy of at least 3 months

• Voluntary participation with the consent of the patient

• Heart, kidney, liver and other organ function evaluation were basically normal before treatment

Exclusion Criteria:

• Patients who previously received chemotherapy

• Uncontrolled cardiovascular diseases, cerebrovascular diseases, thrombotic diseases, autoimmune diseases and serious infectious diseases

• Laboratory indicators before enrollment (unless caused by lymphoma):

• Neutrophils < 1.5 × 10^9/L

• Platelets < 80 × 10^9/L

• Alanine aminotransferase or aspartate aminotransferase > 2 × ULN

• Alkaline phosphatase or bilirubin > 1.5 × ULN

• Creatinine > 1.5 × ULN

• Patients who cannot comply with the agreement due to mental diseases or other unknown reasons such as pregnancy and lactation

• HIV infection

• If HBsAg is positive, HBVDNA should be tested, and patients with positive DNA cannot be enrolled; if HBsAg is negative and HBcAb is positive (regardless of HBsAb status), HBVDNA should be tested, and patients with positive DNA cannot be enrolled

• Other uncontrolled medical conditions that may interfere with the study