R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden

Study Overview
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Brief Summary
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A single-center, prospective clinical study to evaluate the efficacy and safety of R-CDOP (Rituximab, Cyclophosphamide, Doxorubicin hydrochloride liposome, Vindesine, Prednisone ) in the treatment of newly diagnosed high tumor burden non-Hodgkin's lymphoma, which has previously shown promising efficacy.

Detailed Description
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The objective was to evaluate the efficacy and safety of R-CDOP regimen in the initial treatment of Patients with at least one of the following high tumor burden, and to provide a basis for the application of Doxorubicin hydrochloride liposome. At least 3 nodal sites (each with a diameter greater than 3 cm) ; Nodal or extranodal mass > 7cm in its greater diameter; Hepatomegaly and splenomegaly (infiltration confirmed by PET-CT; Spleen: female > 15cm, male > 16cm) ; Pleural/peritoneal effusion; Lactate dehydrogenase (LDH) three times the upper limit of normal; PET-CT Total Metabolic Tumor Volume (TMTV)>220cm3.

Official Title
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A Prospective Clinical Study of R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden

Conditions
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Diffuse Large B Cell Lymphoma, Follicular Lymphoma Grade 3B

Intervention / Treatment
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* Combination Product: R-CDOP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically immunohistochemistry and imaging confirmed diffuse large B-cell lymphoma or follicular lymphoma grade 3B; Has at least one evaluable or measurable lesion according to Lugano response criteria; Patients with at least one of the following high tumor burden Involvement of at least 3 nodal sites (each with a diameter greater than 3 cm); nodal or extranodal mass > 7cm in its greater diameter; Hepatomegaly and splenomegaly (infiltration confirmed by PET-CT; Spleen: female > 15cm, male > 16cm); Pleural/peritoneal effusion; Lactate dehydrogenase (LDH) three times the upper limit of normal; PET-CT TMTV >220cm3; Patients previously untreated; Patients aged over 18 and under 75 years; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 2; International Prognostic Index (IPI) score > 1, or with extranodal mass diameter ≥7cm; Life expectancy ≥ 6 months; Left Ventricular Ejection Fraction (LVEF) ≥ 50%; Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule. Exclusion Criteria: Pregnant or lactation and patients of childbearing age who do not want to take contraceptive measures; Abnormal liver function [total bilirubin > 1.5 times of the upper limit of normal value; Alanine aminotransferase/Aspartate aminotransferase (ALT / AST) > 2.5 times of upper limit of normal value for patients without liver metastasis ; ALT / AST > 5 times of upper limit of normal value for patients with liver metastasis ], abnormal renal function (serum creatinine > 1.5 times of upper limit of normal value) ; Absolute Neutrophil Count (ANC)<1.5×10^9/L or Platelet (PLT)< 75 × 10^9/L; Hypersensitivity to any study drug or its ingredients; Patients with significant and uncontrolled cardiovascular disease or history; Persons with mental disorders/unable to obtain informed consent; Lymphoma infiltrates the central nervous system; Previous history of malignant tumor; HIV infection; HBV infection (HBV-DNA> 2000 IU/ml);HCV infection (HCV-RNA>200 IU/ml); The investigator determined not suitable to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R-CDOP<br>Rituximab 375mg/m2, D0; Cyclophosphamide 750mg/ m2, D1; Doxorubicin hydrochloride liposome 30-35mg/ m2, D1; Vindesine 3mg/ m2, D1; Prednisone 60mg/ m2, D1 5. | Combination Product: R-CDOP<br>* Rituximab 375mg/m2, D0; Cyclophosphamide 750mg/ m2, D1; Doxorubicin hydrochloride liposome 30-35mg/ m2, D1; Vindesine 3mg/ m2, D1; Prednisone 60mg/ m2, D1 5.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | Percentage of Complete remission (CR), and Partial remission (PR), referred to Lugano 2014. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate | Percentage of Complete remission (CR), Partial remission (PR), and stable disease (SD), referred to Lugano 2014. | 24 months | 
| Progression-free survival | Progression-free survival（PFS） is defined as the time from the date of enrollment to the date of first documentation of progressive disease (PD) or death from any cause. | 24 months | 
| Overall survival | Overall survival（OS） is defined as the time from the date of enrollment to the date of death from any cause. | 60 months | 
| Adverse Events | 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. | 24 months |