Treatment for newly diagnosed high tumor burden non-Hodgkin's lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of the R-CDOP regimen, which includes Rituximab, Cyclophosphamide, Doxorubicin hydrochloride liposome, Vindesine, and Prednisone, in patients with newly diagnosed non-Hodgkin's lymphoma characterized by high tumor burden. The study is a single-center, prospective investigation aimed at patients who meet specific criteria related to tumor size and burden. The goal is to provide a basis for the application of Doxorubicin hydrochloride liposome in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histologically immunohistochemistry and imaging confirmed diffuse large B-cell lymphoma or follicular lymphoma grade 3B;
2. Has at least one evaluable or measurable lesion according to Lugano response criteria;
3. 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;
4. Patients previously untreated;
5. Patients aged over 18 and under 75 years;
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0\~2;
7. International Prognostic Index (IPI) score \> 1, or with extranodal mass diameter ≥7cm;
8. Life expectancy ≥ 6 months;
9. Left Ventricular Ejection Fraction (LVEF) ≥ 50%;
10. 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 Criteria:

1. Pregnant or lactation and patients of childbearing age who do not want to take contraceptive measures;
2. 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) ;
3. Absolute Neutrophil Count (ANC)\<1.5×10\^9/L or Platelet (PLT)\< 75 × 10\^9/L;
4. Hypersensitivity to any study drug or its ingredients;
5. Patients with significant and uncontrolled cardiovascular disease or history;
6. Persons with mental disorders/unable to obtain informed consent;
7. Lymphoma infiltrates the central nervous system;
8. Previous history of malignant tumor;
9. HIV infection; HBV infection (HBV-DNA\> 2000 IU/ml);HCV infection (HCV-RNA\>200 IU/ml);
10. The investigator determined not suitable to participate in this study.

Where it's running

• The First Bethune Hospital of Jilin University
  Changchun, Jilin, China Recruiting

Study contacts

• Study coordinator: Ou BAI, doctor
• Email: oubai16@163.com
• Phone: 13039046656

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.