Rituximab and Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Registration Number
- NCT00278421
- Lead Sponsor
- German High-Grade Non-Hodgkin's Lymphoma Study Group
- Brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which schedule of rituximab and combination chemotherapy is more effective in treating non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and combination chemotherapy to compare how well they work in treating patients with aggressive B-cell non-Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
Primary
* Compare the efficacy of 2 different schedules of immunochemotherapy comprising rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone in patients with previously untreated, low-risk, aggressive B-cell non-Hodgkin's lymphoma.
* Compare acute and chronic side effects in patients treated with these regimens.
* Compare time to treatment failure in patients treated with these regimens.
Secondary
* Compare the time to progression in patients treated with these regimens.
* Compare the overall and disease-free/relapse-free survival of patients treated with these regimens.
* Compare the complete response rate in patients treated with these regimens.
* Compare the tumor control in patients treated with these regimens.
* Compare the safety of these regimens in these patients.
* Compare the pharmacoeconomics of these regimens.
* Compare patient adherence to these regimens.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
All patients are given the option of receiving a 1-week course of pretreatment therapy comprising vincristine IV once on day -6 and oral prednisone once daily on days -6 to 0.
* 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.
All patients undergo final restaging after 6 courses of rituximab. Patients with disease progression, stable disease, or partial response proceed to salvage therapy off study.
After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 622 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 592
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interventional: 6 R-CHOP-21 vincristine sulfate 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. Interventional: 4 R-CHOP-21 + 2 x R rituximab 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. Interventional: 6 R-CHOP-21 rituximab 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. Interventional: 4 R-CHOP-21 + 2 x R vincristine sulfate 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. Interventional: 6 R-CHOP-21 cyclophosphamide 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. Interventional: 6 R-CHOP-21 doxorubicin hydrochloride 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. Interventional: 6 R-CHOP-21 prednisone 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. Interventional: 4 R-CHOP-21 + 2 x R cyclophosphamide 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. Interventional: 4 R-CHOP-21 + 2 x R doxorubicin hydrochloride 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. Interventional: 4 R-CHOP-21 + 2 x R prednisone 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.
- Primary Outcome Measures
Name Time Method Time to treatment failure (TTF) measured from day 1 of course 1 of Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (CHOP) therapy up to 3 years on study with life-long follow-up through study completion
- Secondary Outcome Measures
Name Time Method Tumor control measured from day 1 of course 1 of CHOP therapy (non-tumor related events are censored) through study completion Disease-free survival measured from day 1 of course 1 of CHOP therapy through study completion Safety (adverse events, serious adverse events) assessed at 3 months after treatment through study completion Complete response (CR) rate duration until first relapse through study completion Progression rate during treatment through study completion Survival through study completion
Trial Locations
- Locations (76)
Klinikum Lippe - Lemgo
🇩🇪Lemgo, Germany
Onkologische Schwerpunktpraxis
🇩🇪Wendlingen, Germany
Klinikum Frankfurt (Oder) GmbH
🇩🇪Frankfurt (Oder), Germany
Haematologisch Onkologische Praxis
🇩🇪Aachen, Germany
Klinikum Fulda
🇩🇪Fulda, Germany
Saint Josef Hospital
🇩🇪Gelsenkirchen, Germany
Kreiskrankenhaus Gummersbach GMBH
🇩🇪Gummersbach, Germany
Medizinische Universitaetsklinik I at the University of Cologne
🇩🇪Cologne, Germany
Klinikum Dortmund
🇩🇪Dortmund, Germany
St. Antonius Hospital
🇩🇪Eschweiler, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Clinic for Bone Marrow Transplantation and Hematology and Oncology
🇩🇪Idar-Oberstein, Germany
Haematologisch-Onkologische Praxis Altona
🇩🇪Hamburg, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Universitaetsklinikum Freiburg
🇩🇪Freiburg, Germany
St. Bernward Krankenhaus
🇩🇪Hildesheim, Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
🇩🇪Munich, Germany
Universitaetsklinikum Goettingen
🇩🇪Goettingen, Germany
Evangelische Krankenhaus Hamm
🇩🇪Hamm, Germany
St. Marien-Hospital Hamm - Klinik Knappenstrasse
🇩🇪Hamm, Germany
University Medical Center Hamburg - Eppendorf
🇩🇪Hamburg, Germany
Ruprecht - Karls - Universitaet Heidelberg
🇩🇪Heidelberg, Germany
Universitaetsklinikum des Saarlandes
🇩🇪Homburg, Germany
Krankenhaus Ludmillenstift
🇩🇪Meppen, Germany
Staedtisches Klinikum Karlsruhe gGmbH
🇩🇪Karlsruhe, Germany
Klinikum Kempten Oberallgaeu
🇩🇪Kempten, Germany
University Hospital Schleswig-Holstein - Kiel Campus
🇩🇪Kiel, Germany
St. Vincenz Hospital Limburg
🇩🇪Limburg, Germany
St. Vincentius - Kliniken
🇩🇪Karlsruhe, Germany
Klinikum der Stadt Ludwigshafen am Rhein
🇩🇪Ludwigshafen am Rhein, Germany
Prosper-Hospital Recklinghausen
🇩🇪Recklinghausen, Germany
III Medizinische Klinik Mannheim
🇩🇪Mannheim, Germany
Southwest German Cancer Center at Eberhard-Karls-University
🇩🇪Tuebingen, Germany
Helios Kliniken Wuppertal University Hospital
🇩🇪Wuppertal, Germany
Klinikum Schwaebisch Gmuend Stauferklinik
🇩🇪Mutlangen, Germany
Klinikum Ernst Von Bergmann
🇩🇪Potsdam, Germany
Diakonie Klinikum Stuttgart
🇩🇪Stuttgart, Germany
Krankenanstalt Mutterhaus der Borromaerinnen
🇩🇪Trier, Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Dr. Horst-Schmidt-Kliniken
🇩🇪Wiesbaden, Germany
Onkologische Schwerwpunktpraxis Dr. Ladda
🇩🇪Neumarkt, Germany
Klinikum Oldenburg
🇩🇪Oldenburg, Germany
Ospedale Civile - Piacenza
🇮🇹Piacenza, Italy
St. Marien - Krankenhaus Siegen GMBH
🇩🇪Siegen, Germany
St. Marienhospital - Vechta
🇩🇪Vechta, Germany
Rabin Medical Center - Beilinson Campus
🇮🇱Petah-Tikva, Israel
Arcispedale S. Maria Nuova
🇮🇹Reggio Emilia, Italy
Haematologisch-Onkologische Schwerpunktpraxis - Weilheim
🇩🇪Berlin, Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
🇩🇪Berlin, Germany
St. Sixtus Hospital
🇩🇪Haltern, Germany
Klinikum Augsburg
🇩🇪Augsburg, Germany
Klinikum Bayreuth
🇩🇪Bayreuth, Germany
Caritas - Krakenhaus Lebach
🇩🇪Lebach, Germany
Franziskus Hospital
🇩🇪Bielefeld, Germany
DIAKO Ev. Diakonie Krankenhaus gGmbH
🇩🇪Bremen, Germany
Hospital Kuchwald Chemnitz
🇩🇪Chemnitz, Germany
Praxis Dr. Rheinhold Siegmund - Dr. Matthias Penke
🇩🇪Damme, Germany
Augusta-Kranken-Anstalt gGmbH
🇩🇪Bochum, Germany
Staedtisches Klinikum Braunschweig
🇩🇪Braunschweig, Germany
Carl - Thiem - Klinkum Cottbus
🇩🇪Cottbus, Germany
Praxis Fuer Haematologie Internistische Onkologie
🇩🇪Cologne, Germany
Hans - Susemihl - Krankenhaus
🇩🇪Emden, Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
🇩🇪Greifswald, Germany
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
🇩🇪Hagen, Germany
Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
Kreiskrankenhaus Luedenscheid
🇩🇪Luedenscheid, Germany
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
🇩🇪Magdeburg, Germany
Universitaetsklinikum Giessen und Marburg GmbH - Marburg
🇩🇪Marburg, Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
🇩🇪Munich, Germany
Lukaskrankenhaus Neuss
🇩🇪Neuss, Germany
Schlossbergkliniken Oberstaufen
🇩🇪Oberstaufen, Germany
Krankenhaus Maria Hilf GmbH
🇩🇪Moenchengladbach, Germany
Haematologisch - Onkologische Gemeinschaftspraxis - Muenster
🇩🇪Muenster, Germany
Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
🇩🇪Muenster, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Cellulari ed Ematologia Sapienza
🇮🇹Roma, Italy