Back to resultsR-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden
Primary Purpose
Diffuse Large B Cell Lymphoma, Follicular Lymphoma Grade 3B
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
R-CDOP
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B Cell Lymphoma
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Pregnant or lactation and patients of childbearing age who do not want to take contraceptive measures;
- 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;
- 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;
- Lymphoma infiltrates the central nervous system;
- Previous history of malignant tumor;
- HIV infection; HBV infection (HBV-DNA> 2000 IU/ml);HCV infection (HCV-RNA>200 IU/ml);
- The investigator determined not suitable to participate in this study.
Sites / Locations
- The First Bethune Hospital of Jilin UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
R-CDOP
Arm Description
Rituximab 375mg/m2, D0; Cyclophosphamide 750mg/ m2, D1; Doxorubicin hydrochloride liposome 30-35mg/ m2, D1; Vindesine 3mg/ m2, D1; Prednisone 60mg/ m2, D1~5.
Outcomes
Primary Outcome Measures
Objective response rate
Percentage of Complete remission (CR), and Partial remission (PR), referred to Lugano 2014.
Secondary Outcome Measures
Disease Control Rate
Percentage of Complete remission (CR), Partial remission (PR), and stable disease (SD), referred to Lugano 2014.
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.
Overall survival
Overall survival（OS） is defined as the time from the date of enrollment to the date of death from any cause.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05040555
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
oubai, MD/PhD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma, Follicular Lymphoma Grade 3B
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
R-CDOP
Arm Type
Experimental
Arm Description
Rituximab 375mg/m2, D0; Cyclophosphamide 750mg/ m2, D1; Doxorubicin hydrochloride liposome 30-35mg/ m2, D1; Vindesine 3mg/ m2, D1; Prednisone 60mg/ m2, D1~5.
Intervention Type
Combination Product
Intervention Name(s)
R-CDOP
Intervention Description
Rituximab 375mg/m2, D0; Cyclophosphamide 750mg/ m2, D1; Doxorubicin hydrochloride liposome 30-35mg/ m2, D1; Vindesine 3mg/ m2, D1; Prednisone 60mg/ m2, D1~5.
Primary Outcome Measure Information:
Title
Objective response rate
Description
Percentage of Complete remission (CR), and Partial remission (PR), referred to Lugano 2014.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Disease Control Rate
Description
Percentage of Complete remission (CR), Partial remission (PR), and stable disease (SD), referred to Lugano 2014.
Time Frame
24 months
Title
Progression-free survival
Description
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.
Time Frame
24 months
Title
Overall survival
Description
Overall survival（OS） is defined as the time from the date of enrollment to the date of death from any cause.
Time Frame
60 months
Title
Adverse Events
Description
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.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Pregnant or lactation and patients of childbearing age who do not want to take contraceptive measures;
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;
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;
Lymphoma infiltrates the central nervous system;
Previous history of malignant tumor;
HIV infection; HBV infection (HBV-DNA> 2000 IU/ml);HCV infection (HCV-RNA>200 IU/ml);
The investigator determined not suitable to participate in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ou BAI, doctor
Phone
13039046656
Email
oubai16@163.com
Facility Information:
Facility Name
The First Bethune Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ou BAI, doctor
Phone
13039046656
Email
oubai16@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden
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