1. Phase I portion of this study will evaluate the efficacy and saftey of toripalimab plus rituximab in treating untreated elderly diffuse large B cell lymphoma patients. 2. The aim of phase II portion of this study will evaluate the efficacy and saftey of toripalimab plus rituximab followed by R-CHOP(rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) regimen in treating untreated elderly diffuse large B cell lymphoma patients.
The study consisted of a phase I and II portion. In phase I, patients accepted at least 2 cycles of toripalimab plus rituximab. Another 2 cycles of toripalimab plus rituximab will offered if they achieved CR. In phase II, all patients accpet R-CHOP regimen. If patient get CR after, they will accept 4 cycles of R-CHOP regimen, patients with PR,SD or PD will accept 6 cycles of R-CHOP.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Toripalimab in combination with Rituximab will be administered every 3 weeks up to 4 cycles.
After toripalimab plus rituximab treatment, R-CHOP regimen will be administered every 3 weeks in combination with R-CHOP up to 6 cycles.
Department of hematology department, Nanfang hospital
Guangzhou, Guangdong, China
RECRUITINGOverall Response Rate (ORR) of toripalimab combined with Rituximab , Investigator-Assessed
Overall response 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. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites.
Time frame: upto 36 months
The optimal dosage of Toripalimab combined with Rituximab
Maximum tolerable dose(MTD)and dose-limiting toxicity(DLT)of Toripalimab will be conducted in Phase Ib clinical studies. MTD and DLT is defined as protocol-defined Toripalimab related events.
Time frame: upto 6 months
Overall Response Rate (ORR) of toripalimab combined with Rituximab followed by R-CHOP regimen, Investigator-Assessed
Overall response 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. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites.
Time frame: upto 36 months
Progression-Free Survival (PFS)
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.
Time frame: Time from diagnosis until relapse or progression, non-protocol re-treatment of lymphoma, or death as a result of any cause, assessed up to 36 months
Overall survival(OS)
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.
Time frame: OS is defined as the time from the treatment date to the death from any cause up to 60 months
Percentage of Participants With Adverse Events (AEs)
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.
Time frame: Up to 36 months
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