R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
Sponsoroubai, MD/PhD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
R-CDOP
Combination productRituximab 375mg/m2, D0; Cyclophosphamide 750mg/ m2, D1; Doxorubicin hydrochloride liposome 30-35mg/ m2, D1; Vindesine 3mg/ m2, D1; Prednisone 60mg/ m2, D1\~5.
Treatment groups
64 Participants
are divided into 1 treatment groupGroup A: R-CDOPExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate
Percentage of Complete remission (CR), and Partial remission (PR), referred to Lugano 2014.
Time frame
24 monthsSecondary outcomes
1
Disease Control Rate
Percentage of Complete remission (CR), Partial remission (PR), and stable disease (SD), referred to Lugano 2014.
Time frame
24 months2
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.
Time frame
24 months3
Overall survival
Overall survival（OS） is defined as the time from the date of enrollment to the date of death from any cause.
Time frame
60 months4
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.
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
oubai, MD/PhD
Lead sponsor
The First Hospital of Jilin University
Sponsor institution
Source ClinicalTrials.gov