Clinical trial NCT05040555: R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden
Official title: A Prospective Clinical Study of R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diffuse Large B Cell Lymphoma
Follicular Lymphoma Grade 3B
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The objective was to evaluate the efficacy and safety of R-CDOP regimen in the initial treatment of Patients with at least one of the following high tumor burden, and to provide a basis for the application of Doxorubicin hydrochloride liposome.

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 Total Metabolic Tumor Volume (TMTV)\>220cm3.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate
timeFrame: 24 months
Secondary outcomes:
measure: Disease Control Rate
timeFrame: 24 months
measure: Progression-free survival
timeFrame: 24 months
measure: Overall survival
timeFrame: 60 months
measure: Adverse Events
timeFrame: 24 months
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
Study officials:
References: