Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, Follicular

Lymphoma, B-Cell

Lymphoma, Large-Cell, Anaplastic

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphoma, T-Cell

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Follicular Lymphoma

Anaplastic Large Cell Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Anti-Infective Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Prednisone

Rituximab

Vincristine

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Tubulin Modulators

Antimitotic Agents

TR follow by R-CHOP:

TR: Toripalimab,Rituximab, R-CHOP: Rituximab, Cyclophosphamide,Doxorubicin,Vincristine,Prednisone

Toripalimab in combination with Rituximab will be administered every 3 weeks up to 4 cycles.

Toripalimab, Rituximab

After toripalimab plus rituximab treatment, R-CHOP regimen will be administered every 3 weeks in combination with R-CHOP up to 6 cycles.

R-CHOP Protocol

Huiqiang Huang, Professor

Ru Feng, Professor

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.

Toripalimab Plus Rituximab Followed by R-CHOP for Elderly Patients With Untreated Diffused B Cell Lymphoma

Phase Ib/II Study of Toripalimab In Combination With Rituximab Followed by R-CHOP Regimen (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) for Elderly Naïve Patients With Diffuse Large B-cell Lymphoma

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.

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.

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.

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.

Huiqiang Huang

professor

Apatinib

Protein Kinase Inhibitors

Apatinib should be given at a fixed time. On the day of camrelizumab infusion, Apatinib should be taken 30 minutes after the end of camrelizumab infusion

Camrelizumab will be administered every 3 weeks up to 6 cycles during induction phase, and then every 4 weeks up to 12 cycles in maintenance phase if patients get CR or PR after induction phase.

Camrelizumab

Phase I: dose escalation phase. Patients will oral dosage as 250mg, 500mg or 750mg,qd, per day. Aim to evaluate MTD and DLT, RP2D.

Phase II：Patients continuous oral apatinib as RP2D up to 6 cycles during induction phase, and then 250mg/d up to 1 year in maintenance phase if patients get CR or PR after induction phase.

HuiQiang Huang

This study will evaluate the efficacy and safety of camrelizumab in combination with apatinib in in patients with relapsed or refractory diffuse large B cell lymphoma failed from second line chemotherapy.

Patients with relapsed /refractory diffuse large B cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP. Apatinib is a new type of oral tyrosine kinase inhibitor targeting VEGFR-2. Some studies have shown that the combination of low-dose apatinib and camrelizumab shows a synergistic effect in the exploration of multiple solid tumors, and the adverse reactions of low-dose apatinib are significantly reduced, and the patients are well tolerated.The investigators will evaluate the efficacy and safety of camrelizumab in combination with apatinib in the patients with relapsed refractory diffuse large B cell lymphomafailed from second line chemotherapy.

Camrelizumab in Combination With Apatinib in Refractory and Relapsed DLBCL

Camrelizumab in Combination With Apatinib in in Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma: a Phase Ib/II, Multicentre, Open-label, Single-arm Trial

Overall response was determined on the basis of investigator assessments according to lymphoma response to immunomodulatory therapy criteria (LYRIC) for Malignant Lymphoma, 2016. Tumor assessments were performed with CT/MRI with or without PET.

Maximum tolerable dose（MTD）and dose-limiting toxicity（DLT）of apatinib will be conducted in Phase Ib clinical studies. MTD and DLT is defined as protocol-defined apatinib related events.

The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death

Time from randomization to death for any reason Time from randomization to death for any reason Time from randomization to death for any reason Time from randomization to death for any reason

The time from the first assessment of CR or PR to PD (progressive disease) or death from any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Toripalimab Plus Rituximab Followed by R-CHOP for Elderly Patients With Untreated Diffused B Cell Lymphoma	NCT04058470	Diffuse Large B... High-grade B-ce... Follicular Lymp... Transformed Lym... EBV-Positive DL... ALK-Positive An...	Toripalimab, Ri... R-CHOP Protocol	60 Years - 75 Years	Sun Yat-sen University
Camrelizumab in Combination With Apatinib in Refractory and Relapsed DLBCL	NCT04476459	Diffuse Large B... High-grade B-ce... Follicular Lymp... Transformed Lym... EBV-Positive DL... ALK-Positive An...	Camrelizumab Apatinib	18 Years - 80 Years	Sun Yat-sen University
Camrelizumab in Combination With Apatinib in Refractory and Relapsed DLBCL	NCT04476459	Diffuse Large B... High-grade B-ce... Follicular Lymp... Transformed Lym... EBV-Positive DL... ALK-Positive An...	Camrelizumab Apatinib	18 Years - 80 Years	Sun Yat-sen University

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