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

Conditions

Diffuse Large B-cell Lymphoma, Follicular Lymphoma Grade 3B

Keywords

diffuse large B-cell lymphoma, follicular lymphoma grade 3B

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.

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Interventions

DRUGR-CEOP-70

DRUGR-CEOP-90

DRUGR-CHOP-50

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 80 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
progression free survival	2 year

Secondary

Measure	Time frame	Description
overall survival	2 year	—
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

Countries

China

Outcome results

None listed