The goal of this clinical study is to evaluate the efficacy and safety of sintilimab combined with rituximab followed by R-CHOP regimen in treatment-naïve patients with primary mediastinal diffuse large B-cell lymphoma. The main questions it aims to answer are: 1. Objective response rate of sintilimab combined with rituximab 2. Objective response rate after R-CHOP regimen
Participants will first receive sintilimab plus rituximab for 2 cycles, followed by interim PET-CT assessments. If patients achieve CR or CMR, they will continue to receive 2 courses of sintilimab plus rituximab, followed by 4 cycles of R-CHOP. Patients will receive 6 courses of R-CHOP if they do not achieve CR or CMR after 2 cycles of sintilimab plus rituximab. Patients will undergo PET-CT assessment and will receive 6 cycles of maintenance treatment with nintedanib if CR/CMR/PR is achieved and will be withdrawn from the study if SD/PD occurs. Total treatment cycles will not exceed 14 cycles
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
First strategy of targeted immunotherapy followed by chemotherapy for PMBL. Participants will first receive sintilimab(200mg) plus rituximab(375mg/m2) for 2 cycles. If patients achieve CR or CMR, they will continue to receive 2 courses of sintilimab plus rituximab, followed by 4 cycles of R-CHOP. Patients will receive 6 courses of R-CHOP if they do not achieve CR or CMR after 2 cycles of sintilimab plus rituximab. Patients will undergo PET-CT assessment and will receive 6 cycles of maintenance treatment with nintedanib if CR/CMR/PR is achieved and will be withdrawn from the study if SD/PD occurs. Total treatment cycles will not exceed 14 cycles.
Fujian Cancer Hospital
Fuzhou, Fujian, China
ACTIVE_NOT_RECRUITINGSun yat-sen university cancer cencer
Guangzhou, Guangdong, China
RECRUITINGComplete response rate of Sintilimab combined with rituximab followed by R-CHOP regimen
Investigator-assessed complete response rate of Sintilimab combined with rituximab followed by R-CHOP regimen. Complete response ratewas determined on the basis of investigator assessments according to the Lymphoma response to immunomodulatory therapy criteria (LYRIC) for Malignant Lymphoma, 2016. Tumor assessments were performed with CT/MRI with or without PET.Complete response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites.
Time frame: 36 months
Objective response rate of Sintilimab combined with rituximab followed by R-CHOP regimen
Investigator-assessed objective response rate of Sintilimab combined with rituximab followed by R-CHOP regimen. The overall response rate (ORR) including complete response (CR), and partial response (PR) was determined on the basis of investigator assessments according to the Lymphoma response to immunomodulatory therapy criteria (LYRIC) for Malignant Lymphoma, 2016. Tumor assessments were performed with CT/MRI with or without PET.
Time frame: 36 months
Progression-free survival of whole cohort
Progression-free survival time assessed by investigator for sintilimab combined with rituximab followed by R-CHOP regimen. Statistical analysis will entail descriptive statistics, and survival analysis including Kaplan-Meier estimates, log-rank testing of univariate prognostic factors, Cox proportional hazards analysis, as well as T-testing and regression analysis for comparing continuous variables in correlative study data. PFS was defined as time from diagnosis until relapse or progression, non-protocol re-treatment of lymphoma, or death as a result of any cause.
Time frame: 72 months
Duration of response in responding patients
Duration of response to sequential R-CHOP regimen with sintilimab plus rituximab as assessed by the investigator. Duration of response is defined as the time from the date of first occurrence of CR or PR to the date of the first documented PD or death due to any cause.
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Time frame: 72 months
Overall survival of whole cohort
Overall survival is defined as the time from the treatment date to the death from any cause.
Time frame: 72 months
Incidence of Adverse event
Safety of sintilimab combined with rituximab followed by R-CHOP regimen. An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0
Time frame: 72 months