First-line Treatment of P53 Mutation With PD-L1 Expression in DLBCL With Anti-PD-1 Mab and R-CHOP: a Randomized, Open, Multicenter Clinical Study
Sintilimab
+ Rituximab
Hemic and Lymphatic Diseases+8
+ Immune System Diseases
+ Immunoproliferative Disorders
Treatment Study
Summary
Study start date: March 25, 2022
Actual date on which the first participant was enrolled.This study is a randomized, open, multicenter clinical study to determine whether the addition of sindilizumab to the R-CHOP regimen could improve the objective efficiency of DLBCL patients with P53 mutation with PD-L1 expression and to see if it could prolong patient survival.In this study, patients with P53 mutation with PD-L1 expressing DLBCL were selected to be randomised 1:1 into 2 groups: group A Sindilizumab + R-CHOP and group B R-CHOP. Sindilizumab was administered on day 10 after chemotherapy to avoid interference from prednisone.At the end of 6 cycles, Group A treatment effective maintenance treatment with Sindilizumab for 6 months as indicated.Each patient's tumour tissue was tested for mutations and ctDNA after allocation, and ctDNA and peripheral blood free PD-L1 levels were monitored dynamically during and after treatment.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Ages≥18 years, ≤ 80 years. 2. Patients with primary treatment of DLBCL. 3. Histopathologically confirmed diagnosis of diffuse large B-cell lymphoma. 4. At least one measurable lesion according to the 2014 Lugano criteria. 5. ECOG physical status score of 0, 1 or 2. 6. Laboratory tests meet the following criteria unless judged to be due to lymphoma: 1. Routine blood tests: (in the absence of growth factor support therapy or blood transfusion within 7 days) haemoglobin ≥ 90 g/L, absolute neutrophil value ≥ 1.5 x 109/L, platelet count ≥ 90 x 109/L. 2. Liver biochemistry: serum creatinine ≤ 1.5 x upper limit of normal; total bilirubin ≤ 1.5 x upper limit of normal; glutamate transaminase and glutamic oxalacetic transaminase ≤ 2.5 x upper limit of normal. 3. Coagulation: INR and APTT ≤ 2.5 times the upper limit of normal values. 7. Consent to use contraception during the trial and for 3 months after its completion. 8. Expected survival ≥ 3 months. Exclusion Criteria: 1. Suffering from other untreated malignant tumours. 2. Cardiovascular disease that remains unstable under pharmacological control . 3. With severe interstitial lung disease. 4. With cognitive impairment. 5. Patients with uncontrolled autoimmune disease. 6. Presence of uncontrolled active infection. 7. Expected survival time \< 3 months. 8. Lactating women and subjects of childbearing age who do not wish to use contraception. 9. With poor adherence or unable to follow up regularly.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives