A Prospective Clinical Study of R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Bethune Hospital of Jilin University
RECRUITING
Changchun
Contact Information
Primary
Ou BAI, doctor
oubai16@163.com
13039046656
Time Frame
Start Date: 2021-08-30
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 64
Treatments
Experimental: R-CDOP
Rituximab 375mg/m2, D0; Cyclophosphamide 750mg/ m2, D1; Doxorubicin hydrochloride liposome 30-35mg/ m2, D1; Vindesine 3mg/ m2, D1; Prednisone 60mg/ m2, D1\~5.
Sponsors
Leads: oubai, MD/PhD

This content was sourced from clinicaltrials.gov

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