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.
Min. 3, max. 8 induction cycles. Maintenance with rituximab q. 2 months x 12/24 months, started 2 months after last chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.
Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.
Doxorubicin 50 mg/m2 i.v. d. 1 q. 21 d.
Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.
Prednisone 100 mg p.o. d. 1-5 q. 21 d.
Prednisone 40 mg/m2 p.o. d. 1-5 q. 21 d.
Podkarpacki Oncology Centre
Brzozów, Poland
Voivodeship Hospital, Oncology Ward
Elblag, Poland
Academic Clinical Centre, Hospital of Medical Academy, Clinic of Haematology and Transplantology
Gdansk, Poland
Silesian Medical University, Chair and Clinic of Haematology and Bone Marrow Transplantation
Katowice, Poland
Collegium Medicum Jagiellonian University, Clinic of Haematology
Krakow, Poland
Regional Oncology Centre, Ward of Proliferative Diseases
Lodz, Poland
Oncology Centre of Lublin Region
Lublin, Poland
Central Clinical Hospital, Ministry of Internal Matters and Administration; Clinic of Oncology, Haematology and Internal Diseases
Warsaw, Poland
Institute of Haematology and Transfusiology
Warsaw, Poland
M.Sklodowska-Curie Institute - Oncology Centre
Warsaw, Poland
...and 2 more locations
Event Free Survival
Time frame: +3 yrs
Response Rate
Time frame: +2 yrs
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