Spots Global Cancer Trial Database for First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.
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Trial Identification
Brief Title: First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.
Official Title: First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.A Multicentre, Phase III Randomized Study by the PLRG.
Study ID: NCT00801281
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Podkarpacki Oncology Centre, Brzozów, , Poland
Voivodeship Hospital, Oncology Ward, Elbląg, , Poland
Academic Clinical Centre, Hospital of Medical Academy, Clinic of Haematology and Transplantology, Gdańsk, , Poland
Silesian Medical University, Chair and Clinic of Haematology and Bone Marrow Transplantation, Katowice, , Poland
Collegium Medicum Jagiellonian University, Clinic of Haematology, Kraków, , Poland
Oncology Centre of Lublin Region, Lublin, , Poland
Central Clinical Hospital, Ministry of Internal Matters and Administration; Clinic of Oncology, Haematology and Internal Diseases, Warszawa, , Poland
Institute of Haematology and Transfusiology, Warszawa, , Poland
M.Sklodowska-Curie Institute - Oncology Centre, Warszawa, , Poland
Medical Academy in Wrocław; Chair and Clinic of Haematology, Blood Neoplasm and Bone Marrow Transplantation, Wrocław, , Poland
SP ZOZ Silesian Centre of Cellular Transplantation, Wrocław, , Poland
Regional Oncology Centre, Ward of Proliferative Diseases, Łódź, , Poland
Contact Details
Name: Jan A Walewski, Prof.
Affiliation: Vice-president of PLRG
Role: PRINCIPAL_INVESTIGATOR
Name: Maria Podolak-Dawidziak, Prof.
Affiliation: PLRG Board Member
Role: STUDY_CHAIR
Name: Beata Stella-Hołowiecka, Assoc. Prof.
Affiliation: PLRG Member
Role: STUDY_CHAIR
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