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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 3

Conditions: Diffuse Large B-cell Lymphoma; Follicular Lymphoma Grade 3B

Treatments: Drug: R-CEOP-70; Drug: R-CHOP-50; Drug: R-CEOP-90

Study type: Interventional

Funder types: Other

Identifiers

NCT01852435

NHL-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 648 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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648 participants in 3 patient groups

R-CHOP-50

Active Comparator group

Description:

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.

Treatment:

Drug: R-CHOP-50

R-CEOP-70

Experimental group

Description:

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.

Treatment:

Drug: R-CEOP-70

R-CEOP-90

Experimental group

Description:

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.

Treatment:

Drug: R-CEOP-90