NCT00801281

First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.

First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.A Multicentre, Phase III Randomized Study by the PLRG.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Polish Lymphoma Research Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of event free survival (EFS) of patients treated with the study chemotherapy induction program: R-CHOP compared to the standard R-CVP regimen and response rates, time to best response, PFS, OS, neutropenic fever rate, infection rate, change in Ig levels, change in lymphocyte subpopulations counts in previously untreated indolent lymphoma patients in need of systemic treatment.

Detailed description

Min. 3, max. 8 induction cycles. Maintenance with rituximab q. 2 months x 12/24 months, started 2 months after last chemotherapy.

Conditions

• Follicular Lymphoma
• Marginal Zone Lymphoma
• Small Lymphocytic Lymphoma
• Lymphoplasmacytic Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.
DRUG	Cyclophosphamide	Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.
DRUG	Doxorubicin	Doxorubicin 50 mg/m2 i.v. d. 1 q. 21 d.
DRUG	Vincristine	Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.
DRUG	Prednisone 1	Prednisone 100 mg p.o. d. 1-5 q. 21 d.
DRUG	Prednisone 2	Prednisone 40 mg/m2 p.o. d. 1-5 q. 21 d.

Timeline

• Start date: 2007-02-01
• Primary completion: 2017-06-25
• Completion: 2017-06-25
• First posted: 2008-12-03
• Last updated: 2017-07-17

Locations

12 sites across 1 country: Poland