NCT01148446

R-CHOP Versus R-mini-CEOP in Elderly Patients(>65)With DLBCL

A Randomized Phase III Randomized Study to Compare R-CHOP Versus R-mini-CEOP in Elderly Patients (>65 Years) With Diffuse Large B Cell Lymphoma (DLBCL)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
• Sex: All
• Age: 66 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study has the purpose to compare R-CHOP versus R-mini-CEOP in elderly patients (\>65 years) with Diffuse Large B Cell Lymphoma (DLBCL).

Conditions

• Elderly Patients (>65 Years)
• Diffuse Large B Cell Lymphoma (DLBCL)

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	750 mg/mq IV, day 1
DRUG	Cyclophosphamide	50 mg/mq IV, day 1
DRUG	Doxorubicin	50 mg/mq IV, day1
DRUG	Vincristine	1,4 mg/mq (max 2 mg)IV, day 1
DRUG	Prednisone	75 mg/mq IV, days 1-5
DRUG	Prednisone	60 mg/mq IV/PO, days 1-5
DRUG	Epirubicin	50 mg/mq IV, day 1
DRUG	Vinblastine	5 mg/mq IV, day 1
DRUG	Rituximab	375 mg/mq IV, day 1
DRUG	G-CSF	300 µg tot., SC; days 7-11

Timeline

• Start date: 2003-01-01
• Primary completion: 2006-01-01
• First posted: 2010-06-22
• Last updated: 2010-06-22

Locations

11 sites across 1 country: Italy