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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TR follow by R-CHOP | Experimental | TR follow by R-CHOP: TR: Toripalimab,Rituximab, R-CHOP: Rituximab, Cyclophosphamide,Doxorubicin,Vincristine,Prednisone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab, Rituximab | Drug | Toripalimab in combination with Rituximab will be administered every 3 weeks up to 4 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall 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. | 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. | 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. | upto 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huiqiang Huang, Professor | Contact | +86 020 87343350 | huanghq@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of hematology department, Nanfang hospital | Recruiting | Guangzhou | Guangdong | 510515 | China |
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| R-CHOP Protocol | Drug | After toripalimab plus rituximab treatment, R-CHOP regimen will be administered every 3 weeks in combination with R-CHOP up to 6 cycles. |
|
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| 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. | 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. | Up to 36 months |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D046248 | Pyloric Stenosis, Hypertrophic |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011707 | Pyloric Stenosis |
| D017219 | Gastric Outlet Obstruction |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
| D000069283 | Rituximab |
| C571759 | R-CHOP protocol |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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