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

Diffuse Large B-cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01852435
• Other study ID #: NHL-001
• Status: Active, not recruiting
• Phase: Phase 3
• First received: May 8, 2013
• Last updated: November 10, 2017
• Start date: May 2013
• Est. completion date: February 2018

Study information

• Verified date: November 2017
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 648
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Follicular Lymphoma Grade 3B
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Follicular
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• R-CEOP-70

• R-CEOP-90

• R-CHOP-50

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan
China	Southwest Hospital	Chongqing	Chongqing
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Shandong Provincal Hospital	Jinan
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Shanghai Ruijin Hospital	Shanghai
China	The first hospital of China medical university	Shenyang	Liaoning
China	Shanxi Provincial Tumor Hospital	Taiyuan	Shanxi
China	Institute of Hematology and Blood Diseases Hospital	Tianjin	Tianjin
China	Tongji Hospital	Wuhan	Hubei
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		2 year
Secondary	overall survival		2 year
Secondary	Response rate	21 days as one cycle	Every 4 cycles during treatment and then every 3 months for 2 years
Secondary	Safety as assessed using the CTCAE	21 days as one cycle	Days 1 of each course and then every 3 months for 2 years