Tests R-CDOP treatment in adults with newly diagnosed high-burden non-Hodgkin lymphoma
Tests the R-CDOP drug combination in adults newly diagnosed with large-volume lymphoma.
Plain-language title generated from the registry record
Registry title: R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden
Key facts
- Where
- Changchun, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05040555, who can take part
Where in China
- The First Bethune Hospital of Jilin UniversityChangchun, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- oubai, MD/PhD
- Trial code
- NCT05040555
- Record updated
- 16 September 2021
- Original description
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.Read full original descriptionShow less
A Prospective Clinical Study of R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden
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.
Inclusion: 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: 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; Previous history of malignant tumor; HIV infection; HBV infection (HBV-DNA> 2000 IU/ml);HCV infection (HCV-RNA>200 IU/ml); 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; Pregnant or lactation and patients of childbearing age who do not want to take contraceptive measures; Lymphoma infiltrates the central nervous system; The investigator determined not suitable to participate in this study.