Clinical trial NCT01852435: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diffuse Large B-cell Lymphoma
Follicular Lymphoma Grade 3B
Keywords: diffuse large B-cell lymphoma
follicular lymphoma grade 3B
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2013-05-13
Enrollment: 648
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: progression free survival
timeFrame: 2 year
Secondary outcomes:
measure: overall survival
timeFrame: 2 year
measure: Response rate
timeFrame: Every 4 cycles during treatment and then every 3 months for 2 years
measure: Safety as assessed using the CTCAE
timeFrame: Days 1 of each course and then every 3 months for 2 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Shenyang
country: China
facility: The first hospital of China medical university
state: Liaoning
city: Taiyuan
country: China
facility: Shanxi Provincial Tumor Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Tianjin
country: China
facility: Institute of Hematology and Blood Diseases Hospital
state: Tianjin
city: Jinan
country: China
facility: Shandong Provincal Hospital
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
Study officials:
name: Weili Zhao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.