Diffuse Large B-Cell Lymphoma
Conditions
Brief summary
Diffuse large B-cell lymphoma (DLBCL) is the most common type of lymphoma。The majority of refractory patients have PD-L1 expression due to P53 mutations, some of which account for about 10% of DLBCL.Our department has found that in refractory DLBCL with high PD-L1 expression, cedilizumab monotherapy is also more effective and has reversed chemotherapy resistance.The aim of this study was 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.
Detailed description
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.
Interventions
DRUGSintilimab
After one cycle of standard R-CHOP chemotherapy, Group A uses Sintilimab with R-CHOP, with Sintilimab administered on day 10 post-chemotherapy, scheduled for 5 cycles. After 5 cycles CR patients in group A continue Sindilizumab treatment for 8 times, once every 21 days.
DRUGRituximab
After one cycle of standard R-CHOP chemotherapy, Group B uses R-CHOP for 5 cycles. After 5 cycles, CR patients in group B are followed up for observation.
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients with P53 mutation with PD-L1 expressing DLBCL were randomized 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. after 6 cycles, the treatment effective in Group A was maintained with Sindilizumab for 6 months as usual.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRR | 1 year | To assess complete response rate (CRR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 1 year | Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first). |
| ORR | 1 year | Objective response rate (ORR) |
| OS | 1 year | Defined as the time from the start of treatment to the death of the subject due to any cause. |
Contacts
Primary ContactXiuhua Sun, Master
Outcome results
None listed