Status:
UNKNOWN
R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B
Lead Sponsor:
Ruijin Hospital
Conditions:
Diffuse Large B-cell Lymphoma
Follicular Lymphoma Grade 3B
Eligibility:
All Genders
16-80 years
Phase:
PHASE3
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 patient...
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
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
648 Patients enrolled
Trial Details
Trial ID
NCT01852435
Start Date
May 1 2013
End Date
February 1 2018
Last Update
November 14 2017
Active Locations (12)
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1
Southwest Hospital
Chongqing, Chongqing Municipality, China
2
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
3
Guangdong General Hospital
Guangzhou, Guangdong, China
4
Henan Cancer Hospital
Zhengzhou, Henan, China