Back to resultsR-CHOP Versus R-CDOP as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma
Primary Purpose
Lymphoma, Large B-Cell, Diffuse
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Pegylated liposomal doxorubicin
Doxorubicin
Rituximab
Cyclophophamide
Vincristine
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Large B-Cell, Diffuse focused on measuring Lymphoma, Large B-Cell, Diffuse, liposomal doxorubicin, doxorubicin, event-free survival
Eligibility Criteria
Inclusion Criteria:
- Pathologically confirmed diagnosis of CD20-positive diffuse large B-cell lymphoma
- 60~80 years old
- Ann Arbor stage I~IV
- ECOG physical score of 0~2
- Have not received previous treatment to lymphoma, including chemotherapy, radiotherapy, or biotherapy
- Have at least one clinically measurable lesion: >= 2cm under physical examination, or >= 1.5cm under computed tomography (CT) or magnetic resonance (MR)
- Life expectancy of >= 3 months
- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase and total bilirubin <= 2 × upper limit of normal (ULN)
- Glomerular filtration rate (MDRD method) >= 30ml/min
- No abnormalities in blood coagulative function
- Generally normal bone marrow function: while blood cell >= 3,000/μL, absolute neutrophil count >= 1,500/μL, hemoglobin >= 100g/L, platelet >= 75,000/μL
- No evidence of active hepatitis B or C virus, or human immunodeficiency virus infection
- Left ventricular ejection fraction (LVEF) >= 45% measured by two dimensional echocardiography or multi-gated acquisition (MUGA) scan
- Cardiac function of class I-II in New York Heart Association (NYHA) classification
Exclusion Criteria:
- Patients with indolent lymphoma
- Positive results for in situ hybridization for Epstein-Barr virus encoded RNA (EBER)
- Serum Epstein-Barr virus DNA >= 1,000 copies/ml
- Double-hit lymphoma confirmed by fluorescence in situ hybridization (FISH)
- Primary mediastinal B-cell lymphoma
- Involvement of central nervous system
- Bulky disease (>= 10cm)
- History of cardiac disease, including clinically significant ventricular tachycardia, atrial fibrillation, conduction block, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease which needs medication
- Known allergic reaction to any component of the agents used in the chemotherapeutic regimens that are used in the study
- Previous exposure to anthracycline drugs, rituximab, or chemotherapy for lymphoma
- History of malignant carcinoma within 5 years (except carcinoma in situ of the skin and uterine cervix, and prostatic carcinoma)
- Currently enrolled in other clinical studies
- Other conditions that the investigators consider as inappropriate for enrolling into this study
Sites / Locations
- Guangdong Provincial People's HospitalRecruiting
- Nanfang Hospital of Southern Medical Unversity
- Sun Yat-sen University Cancer CenterRecruiting
- The First Affiliated Hospital of Guangzhou Medical University
- The Second Affiliated Hospital of Sun Yat-sen University
- The Third Affiliated Hospital of Sun Yat-sen University
- Wujing Zongdui Hospital of Guangdong Province
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
R-CHOP
R-CDOP
Arm Description
This group received R-CHOP regimen as the first-line chemotherapy. Rituximab, 375mg/m2, iv, d0; Cyclophophamide, 750mg/m2, iv, d1; Doxorubicin, 50mg/m2, iv, d1; Vincristine, 2mg/m2 (max 2mg), iv, d1; Prednisone, 100mg, po, d1-5. Repeat every 21 days for 6-8 cycles or until the criteria of terminating treatment was met.
This group received R-CDOP regimen as the first-line chemotherapy. Rituximab, 375mg/m2, iv, d0; Cyclophophamide, 750mg/m2, iv, d1; Pegylated liposomal doxorubicin, 30mg/m2, iv, d1; Vincristine, 2mg/m2 (max 2mg), iv, d1; Prednisone, 100mg, po, d1-5. Repeat every 21 days for 6-8 cycles or until the criteria of terminating treatment was met.
Outcomes
Primary Outcome Measures
event-free survival (EFS)
Defined as time from the date of randomization to the date of disease progression, death due to any cause, termination of treatment, or the most recent follow-up
Secondary Outcome Measures
overall response rate (ORR)
defined as the proportion of patients whose best overall response is either complete remission (CR) or partial remission (PR), which was evaluated in accordance with the International Working Group Recommendations for Response Criteria for non-Hodgkin's lymphoma
complete remission (CR) rate
defined as the proportion of patients whose best overall response is complete remission, which was evaluated in accordance with the International Working Group Recommendations for Response Criteria for non-Hodgkin's lymphoma
overall survival (OS)
defined as time from the date of randomization to the date of death due to any cause or the most recent follow-up
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02428751
Brief Title
R-CHOP Versus R-CDOP as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma
Official Title
Rituximab, Cyclophosphamide, Vincristine, and Prednisone in Combination With Doxorubicin (R-CHOP) Versus in Combination With Pegylated-liposomal Doxorubicin (R-CDOP) as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma: a Randomised, Multicentre, Non-inferiority Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wenqi Jiang
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP regimen) has been the first-line chemotherapy for elderly patients with diffuse large B-cell lymphoma (DLBCL). The treatment-related toxicities, especially the severe cardiac toxicities induced by anthracycline drugs (doxorubicin), have become a major concern among elderly patients. Pegylated liposomal doxorubicin is a formulation of doxorubicin with a prolonged circulation time and unique toxicity profile. Previous single arm studies of elderly patients with lymphoma used pegylated liposomal doxorubicin instead of traditional doxorubicin in combination with rituximab, cyclophosphamide, vincristine, and prednisone (the novel R-CDOP regimen), and demonstrated better safety profile, including less bone marrow suppression and less cardiac toxicities, while maintaining the efficacy. However, the efficacy and safety of these two regimens (R-CHOP and R-CDOP) have not been head-to-head compared in a randomized study. The aim of this study is to compare the efficacy and safety of R-CDOP (rituximab, cyclophosphamide, pegylated liposomal doxorubicin, vincristine, and prednisone) and R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in previously untreated elderly patients with DLBCL.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large B-Cell, Diffuse
Keywords
Lymphoma, Large B-Cell, Diffuse, liposomal doxorubicin, doxorubicin, event-free survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
R-CHOP
Arm Type
Active Comparator
Arm Description
This group received R-CHOP regimen as the first-line chemotherapy. Rituximab, 375mg/m2, iv, d0; Cyclophophamide, 750mg/m2, iv, d1; Doxorubicin, 50mg/m2, iv, d1; Vincristine, 2mg/m2 (max 2mg), iv, d1; Prednisone, 100mg, po, d1-5. Repeat every 21 days for 6-8 cycles or until the criteria of terminating treatment was met.
Arm Title
R-CDOP
Arm Type
Experimental
Arm Description
This group received R-CDOP regimen as the first-line chemotherapy. Rituximab, 375mg/m2, iv, d0; Cyclophophamide, 750mg/m2, iv, d1; Pegylated liposomal doxorubicin, 30mg/m2, iv, d1; Vincristine, 2mg/m2 (max 2mg), iv, d1; Prednisone, 100mg, po, d1-5. Repeat every 21 days for 6-8 cycles or until the criteria of terminating treatment was met.
Intervention Type
Drug
Intervention Name(s)
Pegylated liposomal doxorubicin
Intervention Description
30 mg/m2, IV (in the vein) on day 1 of each 21 day cycle
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
50 mg/m2, IV (in the vein) on day 1 of each 21 day cycle
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
375 mg/m2, IV (in the vein) on day 0 of each 21 day cycle
Intervention Type
Drug
Intervention Name(s)
Cyclophophamide
Intervention Description
750 mg/m2, IV (in the vein) on day 1 of each 21 day cycle
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
1.4 mg/m2 (2mg in maxium), IV (in the vein) on day 1 of each 21 day cycle
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
100mg/d, PO on day 1-5 of each 21 day cycle
Primary Outcome Measure Information:
Title
event-free survival (EFS)
Description
Defined as time from the date of randomization to the date of disease progression, death due to any cause, termination of treatment, or the most recent follow-up
Time Frame
two year
Secondary Outcome Measure Information:
Title
overall response rate (ORR)
Description
defined as the proportion of patients whose best overall response is either complete remission (CR) or partial remission (PR), which was evaluated in accordance with the International Working Group Recommendations for Response Criteria for non-Hodgkin's lymphoma
Time Frame
at week 6, 12, 18, and 24 after randomization
Title
complete remission (CR) rate
Description
defined as the proportion of patients whose best overall response is complete remission, which was evaluated in accordance with the International Working Group Recommendations for Response Criteria for non-Hodgkin's lymphoma
Time Frame
at week 6, 12, 18, and 24 after randomization
Title
overall survival (OS)
Description
defined as time from the date of randomization to the date of death due to any cause or the most recent follow-up
Time Frame
two year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathologically confirmed diagnosis of CD20-positive diffuse large B-cell lymphoma
60~80 years old
Ann Arbor stage I~IV
ECOG physical score of 0~2
Have not received previous treatment to lymphoma, including chemotherapy, radiotherapy, or biotherapy
Have at least one clinically measurable lesion: >= 2cm under physical examination, or >= 1.5cm under computed tomography (CT) or magnetic resonance (MR)
Life expectancy of >= 3 months
Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase and total bilirubin <= 2 × upper limit of normal (ULN)
Glomerular filtration rate (MDRD method) >= 30ml/min
No abnormalities in blood coagulative function
Generally normal bone marrow function: while blood cell >= 3,000/μL, absolute neutrophil count >= 1,500/μL, hemoglobin >= 100g/L, platelet >= 75,000/μL
No evidence of active hepatitis B or C virus, or human immunodeficiency virus infection
Left ventricular ejection fraction (LVEF) >= 45% measured by two dimensional echocardiography or multi-gated acquisition (MUGA) scan
Cardiac function of class I-II in New York Heart Association (NYHA) classification
Exclusion Criteria:
Patients with indolent lymphoma
Positive results for in situ hybridization for Epstein-Barr virus encoded RNA (EBER)
Serum Epstein-Barr virus DNA >= 1,000 copies/ml
Double-hit lymphoma confirmed by fluorescence in situ hybridization (FISH)
Primary mediastinal B-cell lymphoma
Involvement of central nervous system
Bulky disease (>= 10cm)
History of cardiac disease, including clinically significant ventricular tachycardia, atrial fibrillation, conduction block, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease which needs medication
Known allergic reaction to any component of the agents used in the chemotherapeutic regimens that are used in the study
Previous exposure to anthracycline drugs, rituximab, or chemotherapy for lymphoma
History of malignant carcinoma within 5 years (except carcinoma in situ of the skin and uterine cervix, and prostatic carcinoma)
Currently enrolled in other clinical studies
Other conditions that the investigators consider as inappropriate for enrolling into this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen-qi Jiang, M.D.
Phone
86-20-87343765
Email
wenqi_jiang@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xi-wen Bi, M.D.
Phone
86-13826050380
Email
xiwen_bi@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-qi Jiang, M.D.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-yu Li, M.D.
Phone
86-13924196915
First Name & Middle Initial & Last Name & Degree
Wen-yu Li, M.D.
First Name & Middle Initial & Last Name & Degree
Xin Du, M.D.
Facility Name
Nanfang Hospital of Southern Medical Unversity
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Xu, M.D.
Phone
86-18688900980
First Name & Middle Initial & Last Name & Degree
Bing Xu, M.D.
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi-ming Li, M.D.
Phone
86-13719189172
Email
zhimingsysucc@163.com
First Name & Middle Initial & Last Name & Degree
Xi-wen Bi, M.D.
Phone
86-13826050380
Email
xiwen_bi@163.com
First Name & Middle Initial & Last Name & Degree
Wen-qi Jiang, M.D.
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huo Tan, M.D.
Phone
86-13602725539
First Name & Middle Initial & Last Name & Degree
Huo Tan, M.D.
Facility Name
The Second Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li-ping Ma, M.D.
Phone
86-13600450776
First Name & Middle Initial & Last Name & Degree
Li-ping Ma, M.D.
Facility Name
The Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang-yuan Wu, M.D.
Phone
86-13729813256
First Name & Middle Initial & Last Name & Degree
Xiang-yuan Wu, M.D.
Facility Name
Wujing Zongdui Hospital of Guangdong Province
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Zhou, M.D.
Phone
86-18820019866
First Name & Middle Initial & Last Name & Degree
Tao Zhou, M.D.
12. IPD Sharing Statement
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R-CHOP Versus R-CDOP as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma
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