R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B
NCT ID: NCT01852435
Last Updated: 2017-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
648 participants
INTERVENTIONAL
2013-05-31
2018-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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R-CHOP-50
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-CHOP-50
R-CEOP-70
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-70
R-CEOP-90
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.
R-CEOP-90
Interventions
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R-CEOP-70
R-CEOP-90
R-CHOP-50
Eligibility Criteria
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Inclusion Criteria
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
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
16 Years
80 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Zhao Weili
Professor
Principal Investigators
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Weili Zhao, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Locations
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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, , China
Countries
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References
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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.
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.
Other Identifiers
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NHL-001
Identifier Type: -
Identifier Source: org_study_id