NCT05040555Recruiting
R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden
A Prospective Clinical Study of R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden
Source: ClinicalTrials.gov · Last updated 16 Sept 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 31 Aug 2021
- Start date
- 30 Aug 2021
- Primary completion date
- 1 Sept 2023
- Lead sponsor
- oubai, MD/PhD
- NCT number
- NCT05040555
What you commit to
- Study type: Interventional
- Planned participants: 64
- From 30 Aug 2021 to the primary completion date, 1 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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);
Lab values
- 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;
Age
- Pregnant or lactation and patients of childbearing age who do not want to take contraceptive measures;
Other
- Lymphoma infiltrates the central nervous system;
- The investigator determined not suitable to participate in this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Bethune Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.