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New treatment option for Diffuse Large B Cell Lymphoma
Official title R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden
ClinicalTrials.gov ID: NCT05040555
What this study is testing
What is R-CDOP?
R-CDOP is an investigational medicine, being studied as a potential treatment for diffuse large b cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Patients previously untreated;
- Patients aged over 18 and under 75 years;
You likely can't join if
- 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 /...
- 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;
See the full eligibility 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Changchun, Jilin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changchun, Jilin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.