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

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.

Study Overview

• Status: Recruiting
• Conditions: Diffuse Large B Cell Lymphoma; Follicular Lymphoma Grade 3B
• Intervention / Treatment: Combination product: R-CDOP

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.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • The First Bethune Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	Percentage of Complete remission (CR), and Partial remission (PR), referred to Lugano 2014.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Control Rate	Percentage of Complete remission (CR), Partial remission (PR), and stable disease (SD), referred to Lugano 2014.	24 months
Progression-free survival	Progression-free survival（PFS） is defined as the time from the date of enrollment to the date of first documentation of progressive disease (PD) or death from any cause.	24 months
Overall survival	Overall survival（OS） is defined as the time from the date of enrollment to the date of death from any cause.	60 months
Adverse Events	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.	24 months

Collaborators and Investigators

• Sponsor: oubai, MD/PhD

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2028

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 10, 2021

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, B-Cell; Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: CSPC-DMS-NHL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No