R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B

Phase 3

• Conditions: Diffuse Large B-cell Lymphoma; Follicular Lymphoma Grade 3B
• Interventions: Drug: R-CEOP-90; Drug: R-CEOP-70; Drug: R-CHOP-50

• Registration Number: NCT01852435
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-08
• Study First Submitted QC: 2013-05-10
• Study First Posted: 2013-05-13
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-10
• Last Update Posted: 2017-11-14
• Primary Completion: 2017-12
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 648

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
R-CEOP-90	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-70	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-CHOP-50	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.

Primary Outcome Measures

Name	Time	Method
progression free survival	2 year

Secondary Outcome Measures

Name	Time	Method
Response rate	Every 4 cycles during treatment and then every 3 months for 2 years	21 days as one cycle
Safety as assessed using the CTCAE	Days 1 of each course and then every 3 months for 2 years	21 days as one cycle
overall survival	2 year

Trial Locations

Locations (12)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China

The first hospital of China medical university; 🇨🇳 Shenyang, Liaoning, China

Institute of Hematology and Blood Diseases Hospital; 🇨🇳 Tianjin, Tianjin, China

Shandong Provincal Hospital; 🇨🇳 Jinan, China

Shanghai Ruijin Hospital; 🇨🇳 Shanghai, China

Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China

Shanxi Provincial Tumor Hospital; 🇨🇳 Taiyuan, Shanxi, China

West China Hospital; 🇨🇳 Chengdu, Sichuan, China

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China