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

• Status: Unknown status
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital

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