Status:
UNKNOWN
The Efficacy and Safety of ZR2 Versus R-CHOP-like Regimen for Elderly Patients With Newly Diagnosed Diffuse Large B Cell Lymphoma.
Lead Sponsor:
First Affiliated Hospital of Wenzhou Medical University
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief 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 o...
Detailed Description
In this study, elderly DLBCL patients will be treated with ZR2 regimen for the first-line treatment. Investigators will compare the complete response rate, survival and incidence of adverse reactions ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05428670
Start Date
June 15 2022
End Date
June 30 2025
Last Update
June 23 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000