60
Participants
Start Date
February 3, 2015
Primary Completion Date
July 13, 2021
Study Completion Date
July 13, 2022
Rituximab sc
All patients will receive 4 courses of rituximab on days 1, 8, 15 and 22. Rituximab will be administered as a single therapeutic agent at a standard dosage of 375 mg/m2 infused intravenously at day 1. Three subsequent single therapeutic agent applications of rituximab will be administered subcutaneously at a fixed dose of 1400 mg once a week for 3 weeks at days 8, 15 and 22.
Rituximab sc consolidation
Patients considered low-risk will receive four more single therapeutic agent applications of rituximab administered subcutaneously at a fixed dose of 1400 mg once every three weeks at days 50, 71, 92 and 113.
Rituximab sc combined with CHOP chemotherapy
Patients considered high-risk will receive four more applications of rituximab administered subcutaneously at a fixed dose of 1400 mg combined with CHOP chemotherapy every 3 weeks at days 50, 71, 92 and 113. CHOP chemotherapy will be administered at standard doses: cyclophosphamide 750 mg/m2, adriamycine 50 mg/m2, vincristine 1.4mg/m2 (maximum total dose: 2mg) and prednisone 100mg (at day 1 to 5 of each cycle). Cyclophosphamid, adriamycine and vincristine will be infused intravenously. Prednison will be administered orally in a single dose. At day 3-4 of each treatment cycle either a single dose of 6 mg Peg-GCSF or repetitive doses of 5 µg/kg GCSF until recovery of WBC will be applied subcutaneously, as per institutional practice.
Rituximab sc combined with alternating chemotherapy with CHOP and DHAOx
Patients considered very high-risk will receive six more applications of rituximab sc at a fixed dose of 1400 mg combined with chemotherapy every 3 weeks. Chemotherapy is CHOP at days 50, 92 and 134 (cyclophosphamide IV 750 mg/m2, adriamycine IV 50 mg/m2, vincristine IV 1.4mg/m2 (maximum total dose: 2mg) and prednisone PO 100mg (at day 1 to 5 of each cycles). Chemotherapy is DHAOx at days 71, 113 and 155 (oxaliplatin (130 mg/m2, day 1) and cytarabine (ARA-C, 2x 1000 mg/m2 at day 2) dexamethasone PO (40 mg/m2, day 1)), as per institutional practice. At day 3-4 of each treatment cycle either a single dose of 6 mg Peg-GCSF or repetitive doses of 5 µg/kg GCSF until recovery of WBC will be applied subcutaneously, as per institutional practice.
Charite Universitätsmedizin Berlin Campus Mitte, Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie, Berlin
Charité - Universitätsmedizin Berlin CCM Medizinische Klinik m. S. Nephrologie, Berlin
Universitätsmedizin Rostock Klinik für Innere Medizin III Hämatologie, Onkologie, Palliativmedizin, Rostock
II. Medizinische Klinik, Universitätsklinikum Schleswig-Holstein Campus Kiel, Kiel
Malteser Krankenhaus St. Franziskus-Hospital Med. Klinik 1, Flensburg
Klinikum Oldenburg gGmbH Klinik für Innere Medizin II, Oldenburg
DIAKO Bremen gGmbH, Klinik für Hämatologie und Onkologie, Bremen
Medizinische Hochschule Hannover Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Hanover
Universitätsklinikum Gießen Med. Klinik IV, Giessen
Universitätsklinikum Essen Klinik für Hämatologie, Essen
Uniklinik RWTH Aaachen Klinik für Onkologie, Hämatologie und Stammzell-transplantation Med. Klinik IV, Aachen
Universitätsklinikum Bonn Med. Klinik III/ZIM Hämatologie/Onkologie, Bonn
Universitätsmedizin der Johannes-Gutenberg-Universität III. Medizinische Klinik, Mainz
Universitätsklinikum Frankfurt Med. Klinik III, Nephrologie, Frankfurt am Main
Klinikum Stuttgart Klinik für Hämatologie und int. Onkologie, Stuttgart
Klinikum der Universität München-Großhadern Med. Klinik III, München
Universitätsklinikum Erlangen Med. Klinik 5 Hämatologie und Intern. Onkologie, Erlangen
Klinikum Passau II. Med. Klinik, Passau
Diako Ev. Diakonie-Krankenhaus gemeinnützige GmbH
OTHER