Overview

This trial is active, not recruiting.

Conditions diffuse large b-cell lymphoma, follicular lymphoma grade 3b
Treatments r-ceop-70, r-ceop-90, r-chop-50
Phase phase 3
Sponsor Ruijin Hospital
Start date May 2013
End date April 2017
Trial size 648 participants
Trial identifier NCT01852435, NHL-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
r-chop-50
(Experimental)
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-ceop-70
(Experimental)
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-90

Primary Outcomes

Measure
progression free survival
time frame: 2 year

Secondary Outcomes

Measure
overall survival
time frame: 2 year
Response rate
time frame: Every 4 cycles during treatment and then every 3 months for 2 years
Safety as assessed using the CTCAE
time frame: Days 1 of each course and then every 3 months for 2 years

Eligibility Criteria

Male or female participants from 16 years up to 80 years old.

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

Additional Information

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
Principal investigator Weili Zhao, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Ruijin Hospital.