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

  • Histologically confirmed de novo diffuse large B-cell lymphoma or follicular lymphoma grade 3B
  • Age>=16 y.o.,<=80 y.o.
  • ECOG < 3
  • No past history of malignancy
  • 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.
  • Life expectancy>6 months
  • Informed consented

Exclusion Criteria

  • Chemotherapy before
  • Bone marrow transplantation before
  • History of malignancy
  • Active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy
  • Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
  • Primary cutaneous, CNS, mediastinal DLBCL
  • LVEF≤50%
  • Other uncontrollable medical condition that may that may interfere the participation of the study
  • 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
  • Not able to comply to the protocol for mental or other unknown reasons
  • Pregnant or lactation
  • Active liver or biliary disease
  • 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.
  • 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.