R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B
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
1 other identifier
interventional
648
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2013
Longer than P75 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 8, 2013
CompletedFirst Posted
Study publicly available on registry
May 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedNovember 14, 2017
November 1, 2017
4.6 years
May 8, 2013
November 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
progression free survival
2 year
Secondary Outcomes (3)
overall survival
2 year
Response rate
Every 4 cycles during treatment and then every 3 months for 2 years
Safety as assessed using the CTCAE
Days 1 of each course and then every 3 months for 2 years
Study Arms (3)
R-CHOP-50
ACTIVE COMPARATORR-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
EXPERIMENTALR-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
EXPERIMENTALR-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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (12)
Southwest Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Hospital
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The first hospital of China medical university
Shenyang, Liaoning, China
Shanxi Provincial Tumor Hospital
Taiyuan, Shanxi, China
West China Hospital
Chengdu, Sichuan, China
Institute of Hematology and Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Shandong Provincal Hospital
Jinan, China
Shanghai Ruijin Hospital
Shanghai, 200025, China
Related Publications (2)
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.
PMID: 33107145DERIVEDXu 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.
PMID: 31126528DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weili Zhao, MD, PhD
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 8, 2013
First Posted
May 13, 2013
Study Start
May 1, 2013
Primary Completion
December 1, 2017
Study Completion
February 1, 2018
Last Updated
November 14, 2017
Record last verified: 2017-11