Status:
NOT_YET_RECRUITING
First-line Treatment of P53 Mutation With PD-L1 Expression in DLBCL With Anti-PD-1 Mab and R-CHOP
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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.O...
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 m...
Eligibility Criteria
Inclusion
- Ages≥18 years, ≤ 80 years.
- Patients with primary treatment of DLBCL.
- Histopathologically confirmed diagnosis of diffuse large B-cell lymphoma.
- At least one measurable lesion according to the 2014 Lugano criteria.
- ECOG physical status score of 0, 1 or 2.
- Laboratory tests meet the following criteria unless judged to be due to lymphoma:
- 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.
- 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.
- Coagulation: INR and APTT ≤ 2.5 times the upper limit of normal values.
- Consent to use contraception during the trial and for 3 months after its completion.
- Expected survival ≥ 3 months.
Exclusion
- Suffering from other untreated malignant tumours.
- Cardiovascular disease that remains unstable under pharmacological control .
- With severe interstitial lung disease.
- With cognitive impairment.
- Patients with uncontrolled autoimmune disease.
- Presence of uncontrolled active infection.
- Expected survival time \< 3 months.
- Lactating women and subjects of childbearing age who do not wish to use contraception.
- With poor adherence or unable to follow up regularly.
Key Trial Info
Start Date :
March 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05280626
Start Date
March 25 2022
End Date
December 31 2026
Last Update
March 15 2022
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