NCT05280626Not yet recruitingPhase 2
First-line Treatment of P53 Mutation With PD-L1 Expression in DLBCL With Anti-PD-1 Mab and R-CHOP
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
Source: ClinicalTrials.gov · Last updated 15 Mar 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 6 Mar 2022
- Start date
- 25 Mar 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT05280626
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 25 Mar 2022 to the primary completion date, 31 Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Age
- Lactating women and subjects of childbearing age who do not wish to use contraception.
Other
- Expected survival time \< 3 months.
- With poor adherence or unable to follow up regularly.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.