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
Qualifiers
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
Treatments tested in this trial
- R-CDOP
Treatment groups
64 Participants
are divided into 1 treatment groupSponsors and collaborators
oubai, MD/PhD
Lead sponsor
The First Hospital of Jilin University
Sponsor institution
Source ClinicalTrials.gov