Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-CHOP-50 | Active Comparator | 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 | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-CEOP-70 | Drug |
| ||
| R-CEOP-90 |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 2 year | |
| Response rate | 21 days as one cycle | Every 4 cycles during treatment and then every 3 months for 2 years |
Not provided
Inclusion Criteria:
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)
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Weili Zhao, MD, PhD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Hospital | Chongqing | Chongqing Municipality | China | |||
| Fujian Medical University Union Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33107145 | Derived | 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. | |
| 31126528 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| R-CHOP-50 | Drug |
|
| Safety as assessed using the CTCAE |
21 days as one cycle |
| Days 1 of each course and then every 3 months for 2 years |
| 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 |
| 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. |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided