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R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B

Primary Purpose

Diffuse Large B-cell Lymphoma, Follicular Lymphoma Grade 3B

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
R-CEOP-70
R-CEOP-90
R-CHOP-50
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring diffuse large B-cell lymphoma, follicular lymphoma grade 3B

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically confirmed de novo diffuse large B-cell lymphoma or follicular lymphoma grade 3B
  2. Age>=16 y.o.,<=80 y.o.
  3. ECOG < 3
  4. No past history of malignancy
  5. Radiologically measurable disease, CT imaging in screening showing 2 or more clearly demarcated lesions with a largest diameter > 1.5 cm, or 1 clearly demarcated lesion with a largest diameter > 2.0 cm.
  6. Life expectancy>6 months
  7. Informed consented

Exclusion Criteria:

  1. Chemotherapy before
  2. Bone marrow transplantation before
  3. History of malignancy
  4. Active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy
  5. Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
  6. Primary cutaneous, CNS, mediastinal DLBCL
  7. LVEF≤50%
  8. Other uncontrollable medical condition that may that may interfere the participation of the study

  9. Lab at enrollment(unless caused by lymphoma)

    • Neutrophile<1.5*10^9/L
    • Platelet<80*10^9/L
    • Hemoglobulin<100g/L
    • ALT or AST >2*ULN,AKP or bilirubin >1.5*ULN
    • Creatinine>1.5*ULN
  10. Not able to comply to the protocol for mental or other unknown reasons
  11. Pregnant or lactation
  12. Active liver or biliary disease
  13. If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
  14. HIV infection

Sites / Locations

  • Southwest Hospital
  • Fujian Medical University Union Hospital
  • Guangdong General Hospital
  • Henan Cancer Hospital
  • Tongji Hospital
  • Jiangsu Province Hospital
  • The first hospital of China medical university
  • Shanxi Provincial Tumor Hospital
  • West China Hospital
  • Institute of Hematology and Blood Diseases Hospital
  • Shandong Provincal Hospital
  • Shanghai Ruijin Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

R-CHOP-50

R-CEOP-70

R-CEOP-90

Arm Description

R-CHOP-50 (Rituximab 375 mg/m2 d1+Cyclophosphomide 750mg/m2 d2+Adriamycin 50mg/m2 d2+vincristine 1.4mg/m2 d2+Prednisone 60 mg/m2 d2-6) every 21 days for 6 cycles, followed by Rituximab 375 mg/m2 every 21 days for 2 cycles.

R-CEOP-70 (Rituximab 375 mg/m2 d1+Cyclophosphomide 750mg/m2 d2+Adriamycin 70mg/m2 d2+vincristine 1.4mg/m2 d2+Prednisone 60 mg/m2 d2-6) every 21 days for 6 cycles, followed by Rituximab 375 mg/m2 every 21 days for 2 cycles.

R-CEOP-90 (Rituximab 375 mg/m2 d1+Cyclophosphomide 750mg/m2 d2+Adriamycin 90mg/m2 d2+vincristine 1.4mg/m2 d2+Prednisone 60 mg/m2 d2-6) every 21 days for 6 cycles, followed by Rituximab 375 mg/m2 every 21 days for 2 cycles.

Outcomes

Primary Outcome Measures

progression free survival

Secondary Outcome Measures

overall survival
Response rate
21 days as one cycle
Safety as assessed using the CTCAE
21 days as one cycle

Full Information

First Posted
May 8, 2013
Last Updated
November 10, 2017
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01852435
Brief Title
R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B
Official Title
A Multi-center, Prospective, Randomized Phase III Study of the Safety and Efficacy of R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of this study is to evaluate the safety and efficacy of R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell lymphoma and Follicular Lymphoma Grade 3B patients.
Detailed Description
The study aims to evaluate the safety and efficacy of R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell lymphoma and Follicular Lymphoma Grade 3B patients.

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
Keywords
diffuse large B-cell lymphoma, follicular lymphoma grade 3B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
648 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R-CHOP-50
Arm Type
Active Comparator
Arm Description
R-CHOP-50 (Rituximab 375 mg/m2 d1+Cyclophosphomide 750mg/m2 d2+Adriamycin 50mg/m2 d2+vincristine 1.4mg/m2 d2+Prednisone 60 mg/m2 d2-6) every 21 days for 6 cycles, followed by Rituximab 375 mg/m2 every 21 days for 2 cycles.
Arm Title
R-CEOP-70
Arm Type
Experimental
Arm Description
R-CEOP-70 (Rituximab 375 mg/m2 d1+Cyclophosphomide 750mg/m2 d2+Adriamycin 70mg/m2 d2+vincristine 1.4mg/m2 d2+Prednisone 60 mg/m2 d2-6) every 21 days for 6 cycles, followed by Rituximab 375 mg/m2 every 21 days for 2 cycles.
Arm Title
R-CEOP-90
Arm Type
Experimental
Arm Description
R-CEOP-90 (Rituximab 375 mg/m2 d1+Cyclophosphomide 750mg/m2 d2+Adriamycin 90mg/m2 d2+vincristine 1.4mg/m2 d2+Prednisone 60 mg/m2 d2-6) every 21 days for 6 cycles, followed by Rituximab 375 mg/m2 every 21 days for 2 cycles.
Intervention Type
Drug
Intervention Name(s)
R-CEOP-70
Intervention Type
Drug
Intervention Name(s)
R-CEOP-90
Intervention Type
Drug
Intervention Name(s)
R-CHOP-50
Primary Outcome Measure Information:
Title
progression free survival
Time Frame
2 year
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
2 year
Title
Response rate
Description
21 days as one cycle
Time Frame
Every 4 cycles during treatment and then every 3 months for 2 years
Title
Safety as assessed using the CTCAE
Description
21 days as one cycle
Time Frame
Days 1 of each course and then every 3 months for 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed de novo diffuse large B-cell lymphoma or follicular lymphoma grade 3B Age>=16 y.o.,<=80 y.o. ECOG < 3 No past history of malignancy Radiologically measurable disease, CT imaging in screening showing 2 or more clearly demarcated lesions with a largest diameter > 1.5 cm, or 1 clearly demarcated lesion with a largest diameter > 2.0 cm. Life expectancy>6 months Informed consented Exclusion Criteria: Chemotherapy before Bone marrow transplantation before History of malignancy Active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease Primary cutaneous, CNS, mediastinal DLBCL LVEF≤50% Other uncontrollable medical condition that may that may interfere the participation of the study Lab at enrollment(unless caused by lymphoma) Neutrophile<1.5*10^9/L Platelet<80*10^9/L Hemoglobulin<100g/L ALT or AST >2*ULN,AKP or bilirubin >1.5*ULN Creatinine>1.5*ULN Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation Active liver or biliary disease If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled. HIV infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weili Zhao, MD, PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The first hospital of China medical university
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Shanxi Provincial Tumor Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Institute of Hematology and Blood Diseases Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Shandong Provincal Hospital
City
Jinan
Country
China
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
ZIP/Postal Code
200025
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33107145
Citation
Sun R, Zheng Z, Wang L, Cheng S, Shi Q, Qu B, Fu D, Leboeuf C, Zhao Y, Ye J, Janin A, Zhao WL. A novel prognostic model based on four circulating miRNA in diffuse large B-cell lymphoma: implications for the roles of MDSC and Th17 cells in lymphoma progression. Mol Oncol. 2021 Jan;15(1):246-261. doi: 10.1002/1878-0261.12834. Epub 2020 Nov 9.
Results Reference
derived
PubMed Identifier
31126528
Citation
Xu PP, Fu D, Li JY, Hu JD, Wang X, Zhou JF, Yu H, Zhao X, Huang YH, Jiang L, Liu F, Su LP, Chen ZW, Zeng QS, Chen JP, Fang MY, Ma J, Liu T, Song YP, Yu K, Li Y, Qiu LG, Chen XQ, Gu J, Yan JS, Hou M, Huang HY, Wang L, Cheng S, Shen Y, Xiong H, Chen SJ, Zhao WL. Anthracycline dose optimisation in patients with diffuse large B-cell lymphoma: a multicentre, phase 3, randomised, controlled trial. Lancet Haematol. 2019 Jun;6(6):e328-e337. doi: 10.1016/S2352-3026(19)30051-1.
Results Reference
derived

Learn more about this trial

R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B

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