Rituximab and Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, stage I grade 3 follicular lymphoma, contiguous stage II adult diffuse large cell lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult diffuse mixed cell lymphoma, nodal marginal zone B-cell lymphoma, anaplastic large cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, stage I adult immunoblastic large cell lymphoma, contiguous stage II adult Burkitt lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II adult Burkitt lymphoma, noncontiguous stage II mantle cell lymphoma, stage I adult Burkitt lymphoma, stage I mantle cell lymphoma, contiguous stage II marginal zone lymphoma, noncontiguous stage II marginal zone lymphoma, stage I marginal zone lymphoma, stage III marginal zone lymphoma, stage IV marginal zone lymphoma, stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage IV adult Burkitt lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma, including the following subtypes: Grade 3 follicular lymphoma Diffuse B-cell lymphoma, including diffuse large cell lymphoma with any of the following variants: Centroblastic Immunoblastic Plasmablastic Anaplastic large cell T-cell-rich B-cell lymphoma Primary effusion lymphoma Intravascular B-cell lymphoma Primary mediastinal B-cell lymphoma Burkitt's or Burkitt-like lymphoma Mantle cell lymphoma (blastoid) Aggressive marginal zone lymphoma (monocytoid) Previously untreated disease CD20-positive disease International Prognostic Index (IPI) score 0 No bulky disease Largest single or conglomerate tumor < 7.5 cm in diameter No mucosa-associated lymphoid tissue (MALT) lymphoma No CNS involvement of lymphoma (intracerebral, meningeal, or intraspinal) PATIENT CHARACTERISTICS: ECOG performance status 0-1 Platelet count ≥ 100,000/mm^3 WBC ≥ 2,500/mm^3 Lactate dehydrogenase normal Not pregnant or lactating Fertile patients must use effective contraception during and for 1 year after study participation Negative pregnancy test No known hypersensitivity to the study medications No known HIV-positivity No active hepatitis infection No impaired left ventricular function No severe cardiac arrhythmias No other impaired organ function No other serious disorder No other malignancy within the past 5 years except carcinoma in situ or basal cell skin cancer PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy No prior immunosuppressive treatment with cytostatics No planned radiotherapy to extranodal involvement No concurrent participation in other treatment studies
Sites / Locations
- Haematologisch Onkologische Praxis
- Klinikum Augsburg
- Klinikum Bayreuth
- Haematologisch-Onkologische Schwerpunktpraxis - Weilheim
- Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
- Franziskus Hospital
- Augusta-Kranken-Anstalt gGmbH
- Staedtisches Klinikum Braunschweig
- DIAKO Ev. Diakonie Krankenhaus gGmbH
- Hospital Kuchwald Chemnitz
- Praxis Fuer Haematologie Internistische Onkologie
- Medizinische Universitaetsklinik I at the University of Cologne
- Carl - Thiem - Klinkum Cottbus
- Praxis Dr. Rheinhold Siegmund - Dr. Matthias Penke
- Klinikum Dortmund
- Hans - Susemihl - Krankenhaus
- St. Antonius Hospital
- Universitaetsklinikum Essen
- Klinikum Frankfurt (Oder) GmbH
- Universitaetsklinikum Freiburg
- Klinikum Fulda
- Saint Josef Hospital
- Universitaetsklinikum Goettingen
- Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
- Kreiskrankenhaus Gummersbach GMBH
- St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
- St. Sixtus Hospital
- Asklepios Klinik St. Georg
- University Medical Center Hamburg - Eppendorf
- Haematologisch-Onkologische Praxis Altona
- St. Marien-Hospital Hamm - Klinik Knappenstrasse
- Evangelische Krankenhaus Hamm
- Medizinische Hochschule Hannover
- Ruprecht - Karls - Universitaet Heidelberg
- St. Bernward Krankenhaus
- Universitaetsklinikum des Saarlandes
- Clinic for Bone Marrow Transplantation and Hematology and Oncology
- Staedtisches Klinikum Karlsruhe gGmbH
- St. Vincentius - Kliniken
- Klinikum Kempten Oberallgaeu
- University Hospital Schleswig-Holstein - Kiel Campus
- Caritas - Krakenhaus Lebach
- Klinikum Lippe - Lemgo
- St. Vincenz Hospital Limburg
- Klinikum der Stadt Ludwigshafen am Rhein
- Kreiskrankenhaus Luedenscheid
- Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
- III Medizinische Klinik Mannheim
- Universitaetsklinikum Giessen und Marburg GmbH - Marburg
- Krankenhaus Ludmillenstift
- Krankenhaus Maria Hilf GmbH
- Haematologisch - Onkologische Gemeinschaftspraxis - Muenster
- Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
- Klinikum der Universitaet Muenchen - Grosshadern Campus
- Klinikum Rechts Der Isar - Technische Universitaet Muenchen
- Klinikum Schwaebisch Gmuend Stauferklinik
- Onkologische Schwerwpunktpraxis Dr. Ladda
- Lukaskrankenhaus Neuss
- Schlossbergkliniken Oberstaufen
- Klinikum Oldenburg
- Klinikum Ernst Von Bergmann
- Prosper-Hospital Recklinghausen
- St. Marien - Krankenhaus Siegen GMBH
- Diakonie Klinikum Stuttgart
- Krankenanstalt Mutterhaus der Borromaerinnen
- Southwest German Cancer Center at Eberhard-Karls-University
- Universitaetsklinikum Tuebingen
- Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
- St. Marienhospital - Vechta
- Onkologische Schwerpunktpraxis
- Dr. Horst-Schmidt-Kliniken
- Helios Kliniken Wuppertal University Hospital
- Rabin Medical Center - Beilinson Campus
- Ospedale Civile - Piacenza
- Arcispedale S. Maria Nuova
- Cellulari ed Ematologia Sapienza
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Interventional: 6 R-CHOP-21
Interventional: 4 R-CHOP-21 + 2 x R
Arm I: Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo restaging of their disease. Patients with disease progression proceed to salvage therapy off study. All other patients receive 3 more courses of R-CHOP.
Arm II: Patients receive R-CHOP as in arm I. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo restaging of their disease. Patients with disease progression proceed to salvage therapy off study. All other patients receive 1 more course of R-CHOP followed by 2 courses of rituximab alone.