Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma
Randomised Study Comparing 6 And 8 Cycles Of Chemotherapy With CHOP ( Cyclophosphamide, Doxorubicin, Vincristine And Prednisone) At 14-Day Intervals (CHOP-14), Both With Or Without The Monoclonal Anti-CD20 Antibody Rituximab In Patients Aged 61 To 80 Years With Aggressive Non-Hodgkin's Lymphoma
3 other identifiers
interventional
1,506
2 countries
174
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without rituximab in treating aggressive non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying how well giving cyclophosphamide, doxorubicin, vincristine, and prednisone together with or without rituximab works in treating older patients who have aggressive non-Hodgkin's lymphoma. (This trial is no longer randomized as of 6/2005).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 lymphoma
Started Jan 2001
Typical duration for phase_3 lymphoma
174 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2001
CompletedFirst Submitted
Initial submission to the registry
January 24, 2003
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 5, 2010
CompletedMay 18, 2021
May 1, 2021
9.6 years
January 24, 2003
May 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to treatment failure at 3 years within the study and then periodically after study completion
3 years within the study and then periodically after study completion
Secondary Outcomes (5)
Complete response rate at 3 years within the study and then periodically after study completion
3 years within the study and then periodically after
Progression rate
3 years within the study and then periodically after
Survival
3 years within the study and then periodically after
Tumor control
3 years within the study and then periodically after
Disease-free survival
3 years within the study and then periodically after
Study Arms (4)
S6
EXPERIMENTAL6x CHOP-14
R6
EXPERIMENTAL6x CHOP-14 + 8x Rituximab
S8
EXPERIMENTAL8x CHOP-14
R8
EXPERIMENTAL8x CHOP-14 + 8x Rituximab
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (174)
Haematologisch Onkologische Praxis
Aachen, 52070, Germany
Klinikum St. Marien
Amberg, D-92224, Germany
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
Ansbach, 91522, Germany
II. Medizinische Klinik
Aschaffenburg, 63739, Germany
Specialist Practice for Oncology
Aschaffenburg, 63739, Germany
Haematologische Praxis
Augsburg, 86150, Germany
Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg
Augsburg, 86150, Germany
Klinikum Augsburg
Augsburg, D-86156, Germany
Kreiskrankenhaus Aurich
Aurich, D-26603, Germany
Regional Hospital Bad Hersfeld
Bad Hersfeld, 36251, Germany
Humaine - Clinic
Bad Saarow, 15523, Germany
Krankenhaus Hohe Warte Mediziniche Klinik
Bayreuth, D-95445, Germany
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
Berlin, 13125, Germany
Haematologisch-Onkologische Schwerpunktpraxis
Berlin, 13357, Germany
Hospital Complex Bernburg
Bernburg, 06406, Germany
Krankenhaus Bietigheim
Bietigheim, D-74321, Germany
Saint Agnes Hospital
Bocholt, 46397, Germany
Saint Josef Hospital
Bochum, 44791, Germany
Knappschaft Krankenhaus
Bochum, D-44892, Germany
Medizinische Poliklinik
Bonn, D-53111, Germany
Rheinische Friedrich-Wilhelms-Universitat
Bonn, D-53113, Germany
DIAKO Ev. Diakonie Krankenhaus gGmbH
Bremen, 28239, Germany
Medizinische Klinik Am Lukas - Krankenhaus
Bünde, D-32257, Germany
General Hospital
Celle, 29223, Germany
Hospital Kuchwald Chemnitz
Chemnitz, 09113, Germany
Praxis Fuer Haematologie Internistische Onkologie
Cologne, D-50677, Germany
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, D-50924, Germany
Unknown Facility
Cologne-Kalk, D-51105, Germany
Lung Clinic Cologne-Merheim
Cologne-Merheim, D-51109, Germany
Carl - Thiem - Klinkum Cottbus
Cottbus, 03048, Germany
Klinikum Darmstadt
Darmstadt, D-64283, Germany
Saint Johannes Hospital Dortmund
Dortmund, 44137, Germany
Universitatsklinikum Carl Gustav Carus
Dresden, D-01307, Germany
St. Johannes Hospital - Medical Klinik II
Duisburg, 47166, Germany
Franz Hospital Dulmen
Dülmen, 48249, Germany
Florence-Nightingale-Krankenhause, Deaconess Kaiserswerth
Düsseldorf, 40489, Germany
Hans - Susemihl - Krankenhaus
Emden, 26721, Germany
Klinikum Erfurt
Erfurt, D-99089, Germany
St. Antonius Hospital
Eschweiler, 52249, Germany
Universitaetsklinikum Essen
Essen, 45147, Germany
Krankenhaus Nordwest
Frankfurt, D-60488, Germany
Klinikum Frankfurt (Oder) GmbH
Frankfurt (Oder), D-15236, Germany
Evang. Deaconess Hospital Freiburg
Freiburg im Breisgau, 79110, Germany
Municipal Hospital Complex
Fulda, D-36043, Germany
Robert - Koch Hospital
Gehrden, 30989, Germany
Centre for Internal Medicine Gieben
Giessen, 35392, Germany
Universitaetsklinikum Goettingen
Göttingen, 37075, Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, 17489, Germany
Staedtisches Klinikum Guetersloh
Gütersloh, 33332, Germany
Allgemeines Krankenhaus Hagen
Hagen, 58095, Germany
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
Hagen, 58095, Germany
Krankenhaus St. Elisabeth und St. Barbara
Halle, 06110, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle, 06120, Germany
Universitaetsklinikum Halle
Halle, D-06120, Germany
Unknown Facility
Hamburg, 20095, Germany
University Medical Center Hamburg - Eppendorf
Hamburg, 20251, Germany
Asklepios Klinik Nord Heidberg
Hamburg, 22413, Germany
Allgemeines Krankenhaus Altona
Hamburg, 22763, Germany
Haematologisch-Onkologische Praxis Altona
Hamburg, D-22767, Germany
Evangelische Krankenhaus Hamm
Hamm, 59063, Germany
Unknown Facility
Hanover, 30159, Germany
Henriettenstiftung Krankenhaus
Hanover, 30559, Germany
Krankenhaus Siloah - Medizinische Klinik II
Hanover, D-30449, Germany
Medizinische Hochschule Hannover
Hanover, D-30625, Germany
Oncology Specialists Clinic
Harrislee, D-24955, Germany
Thoraxklinik Heidelberg
Heidelberg, 69126, Germany
Medizinische Universitaetsklinik und Poliklinik
Heidelberg, D-69115, Germany
Regional Hospital Heidenheim
Heidenheim, 89522, Germany
Regional Hospital Am Plattenwald - Bad Friedrichshall
Heilbronn, 74177, Germany
Klinikum Herford
Herford, D-32049, Germany
Marienhospital at Ruhr University Bochum
Herne, D-44625, Germany
Privatklinik Dr. R. Schindlbeck GmbH & Co. KG
Herrsching am Ammersee, D-82211, Germany
Onkologische Schwerpunktpraxis
Hildesheim, D-31134, Germany
Evang. Hospital
Holzminden, 37603, Germany
Medical University Hospital Homburg
Homburg, D-66421, Germany
Hospital Complex Hoyerswerda
Hoyerswerda, 02977, Germany
Gemeinschaftspraxis Innere Medizin
Jena, D-07743, Germany
Klinikum der Friedrich-Schiller Universitaet Jena
Jena, D-07747, Germany
Municipal Hospital Complex of the University
Kaiserslautern, D-67655, Germany
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, 76133, Germany
Red Cross Hospital Kassel
Kassel, 34121, Germany
Staedtisches Krankenhaus Kiel
Kiel, 23116, Germany
Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH
Koblenz, 56068, Germany
Praxis fuer Haematologie und Onkologie
Koblenz, D-56068, Germany
Leonardis Clinic
Kornwestheim, D-70806, Germany
Klinikum Krefeld GmbH
Krefeld, D-47805, Germany
Frankenwald Klinik
Kronach, 96317, Germany
Caritas - Krakenhaus Lebach
Lebach, 66822, Germany
University Leipzig Clinic of Internal Medicine
Leipzig, 04103, Germany
Klinikum "St. Georg" Leipzig
Leipzig, 04129, Germany
Unknown Facility
Leipzig, D-04103, Germany
Klinikum Lippe - Lemgo
Lemgo, D-32657, Germany
St. Vincenz Hospital Limburg
Limburg, 65549, Germany
St. Bonifatius Hospital Lingen
Lingen, 49808, Germany
Dreifaltigkeits Hospital
Lippstadt, 59555, Germany
Klinikum Ludwigsburg
Ludwigsburg, D-71640, Germany
St. Marien Hospital Ludwighafen
Ludwigshafen, 67067, Germany
Municipal Complex of Ludwigshafen
Ludwigshafen, D-67063, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Lübeck, D-23538, Germany
Staedtisches Klinikum Magdeburg - Altstadt
Magdeburg, 39104, Germany
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, 39120, Germany
Johannes Gutenberg University
Mainz, 55131, Germany
III Medizinische Klinik Mannheim
Mannheim, D-68305, Germany
Unknown Facility
Marburg, D-35037, Germany
Universitaetsklinikum Giessen und Marburg GmbH - Marburg
Marburg, D-35043, Germany
Regional Hospital Mayen
Mayen, 56727, Germany
Klinikum Minden
Minden, D-32423, Germany
Unknown Facility
Minden, D-32427, Germany
Unknown Facility
Monchenglasbach/Rheydt, D-41239, Germany
Ev. Hospital Bethesda
Mönchengladbach, 41061, Germany
Hospital Maria-Hilf II
Mönchengladbach, 41063, Germany
Munich Oncologic Practice at Elisenhof
Munich, D-80335, Germany
Klinikum der Universitaet Muenchen - Innenstadt Campus
Munich, D-80336, Germany
Krankenhaus Muenchen Schwabing
Munich, D-80804, Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, D-81377, Germany
Municipal Hospital Munich
Munich, D-81737, Germany
Evangelisches Krankenhaus - Mulheim
Mülheim, 45466, Germany
St. Marien Hospital - Muelheim an der Ruhr
Mülheim, 45468, Germany
Kreiskrankenhaus Muenchberg
Münchberg, 95213, Germany
Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
Münster, D-48129, Germany
Regional Hospital Neumarkt
Neumarkt, 92318, Germany
Staedtisches Klinikum Neunkirchen gGmbH
Neunkirchen, 66538, Germany
Lukaskrankenhaus Neuss
Neuss, D-41464, Germany
Klinikum Nuernberg - Klinikum Nord
Nuremberg, D-90340, Germany
Klinikum Offenburg
Offenburg, D-77654, Germany
Hematologische Praxis
Oldenburg, 26121, Germany
Ev. Hospital Oldenburg
Oldenburg, 26122, Germany
Klinikum Oldenburg
Oldenburg, D-26133, Germany
Paracelsus - Klinik Osnabrueck
Osnabrück, D-49076, Germany
Municipal Hospital Complex
Pforzheim, D-75175, Germany
Klinikum Ernst Von Bergmann
Potsdam, D-14467, Germany
Kreiskrankenhaus Radebeul
Radebeul, D-01445, Germany
Krankenhaus St. Elisabeth - Ravensburg
Ravensburg, 88212, Germany
Klinikum der Universitaet Regensburg
Regensburg, 93042, Germany
Hematologische Onkologische Praxis
Regensburg, 93047, Germany
Krankenhaus Barmherzige Brueder Regensburg
Regensburg, D-93049, Germany
Jakobi Krankenhaus
Rheine, 48431, Germany
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
Rostock, 18057, Germany
Klinik und Poliklinik fuer Strahlentherapie - Universitaetsklinikum Rostock
Rostock, 18059, Germany
Unknown Facility
Rostock, D-18257, Germany
Caritasklinik St. Theresia
Saarbrücken, 66113, Germany
Schwerpunktpraxis fuer Haematologie und Onkologie
Saarbrücken, D-66113, Germany
St. Elizabeth-Klinik Saarlouis
Saarlouis, 66713, Germany
Martin - Luther Hospital
Schleswig, D-24837, Germany
Deaconess Hospital
Schwäbisch Hall, 74523, Germany
Leopoldina - Krankenhaus
Schweinfurt, D-97422, Germany
Evang. Jung-Stilling Hospital
Siegen, 57074, Germany
St. Lukas - Clinic Solingen
Solingen, 42697, Germany
Klinik fuer Onkologie - Katharinenhospital Stuttgart
Stuttgart, 70174, Germany
Diakonie Klinikum Stuttgart
Stuttgart, 70176, Germany
Klinikum Stuttgart - Buergerhospital
Stuttgart, 70191, Germany
Hospital Bad Cannstatt
Stuttgart, 70374, Germany
Robert-Bosch-Krankenhaus
Stuttgart, 70376, Germany
St. Elisabeth Hospital Thuine
Thuine, 49832, Germany
Regional Hospital Traunstein
Traunstein, 83278, Germany
Krankenanstalt Mutterhaus der Borromaerinnen
Trier, D-54290, Germany
Unknown Facility
Trier, D-54290, Germany
Krankenhaus Barmherzigen Brueder
Trier, D-54292, Germany
Hospital Tutzing
Tutzing, 82327, Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, 89081, Germany
Ev. Hospital Unna
Unna, 59403, Germany
St. Marienhospital - Vechta
Vechta, 49377, Germany
Municipal Hospital Complex
Villingen-Schwenningen, D-78045, Germany
Regional Hospital Waldbrol
Waldbröl, 51545, Germany
Evangelisches Krankenhaus Essen Werden
Werden, 45239, Germany
Hospital Wetzler
Wetzlar, 35578, Germany
Deutsche Klinik fuer Diagnostik
Wiesbaden, 65191, Germany
Dr. Horst-Schmidt-Kliniken
Wiesbaden, 65199, Germany
Ev. Hospital Witten-Herdecke
Witten, 58455, Germany
Kliniken St. Antonius
Wuppertal, 42283, Germany
University Wurzburg
Würzburg, 97070, Germany
Municipal Hospital Complex Zwickau
Zwickau, D-08060, Germany
City Hospital Triemli
Zurich, 8063, Switzerland
UniversitaetsSpital Zuerich
Zurich, 8091, Switzerland
Related Publications (8)
Pfreundschuh M, Schubert J, Ziepert M, Schmits R, Mohren M, Lengfelder E, Reiser M, Nickenig C, Clemens M, Peter N, Bokemeyer C, Eimermacher H, Ho A, Hoffmann M, Mertelsmann R, Trumper L, Balleisen L, Liersch R, Metzner B, Hartmann F, Glass B, Poeschel V, Schmitz N, Ruebe C, Feller AC, Loeffler M; German High-Grade Non-Hodgkin Lymphoma Study Group (DSHNHL). Six versus eight cycles of bi-weekly CHOP-14 with or without rituximab in elderly patients with aggressive CD20+ B-cell lymphomas: a randomised controlled trial (RICOVER-60). Lancet Oncol. 2008 Feb;9(2):105-16. doi: 10.1016/S1470-2045(08)70002-0. Epub 2008 Jan 15.
PMID: 18226581RESULTChristofyllakis K, Kaddu-Mulindwa D, Lesan V, Rixecker T, Kos IA, Held G, Regitz E, Pfreundschuh M, Bittenbring JT, Thurner L, Poeschel V, Ziepert M, Altmann B, Bewarder M. An inherited genetic variant of the CEP72 gene is associated with the development of vincristine-induced peripheral neuropathy in female patients with aggressive B-cell lymphoma. Ann Hematol. 2024 Nov;103(11):4599-4606. doi: 10.1007/s00277-024-05973-9. Epub 2024 Sep 4.
PMID: 39227453DERIVEDKuhnl A, Cunningham D, Counsell N, Hawkes EA, Qian W, Smith P, Chadwick N, Lawrie A, Mouncey P, Jack A, Pocock C, Ardeshna KM, Radford J, McMillan A, Davies J, Turner D, Kruger A, Johnson PW, Gambell J, Rosenwald A, Ott G, Horn H, Ziepert M, Pfreundschuh M, Linch D. Outcome of elderly patients with diffuse large B-cell lymphoma treated with R-CHOP: results from the UK NCRI R-CHOP14v21 trial with combined analysis of molecular characteristics with the DSHNHL RICOVER-60 trial. Ann Oncol. 2017 Jul 1;28(7):1540-1546. doi: 10.1093/annonc/mdx128.
PMID: 28398499DERIVEDPfreundschuh M, Poeschel V, Zeynalova S, Hanel M, Held G, Schmitz N, Viardot A, Dreyling MH, Hallek M, Mueller C, Wiesen MH, Witzens-Harig M, Truemper L, Keller U, Rixecker T, Zwick C, Murawski N. Optimization of rituximab for the treatment of diffuse large B-cell lymphoma (II): extended rituximab exposure time in the SMARTE-R-CHOP-14 trial of the german high-grade non-Hodgkin lymphoma study group. J Clin Oncol. 2014 Dec 20;32(36):4127-33. doi: 10.1200/JCO.2013.54.6861. Epub 2014 Nov 17.
PMID: 25403207DERIVEDBittenbring JT, Neumann F, Altmann B, Achenbach M, Reichrath J, Ziepert M, Geisel J, Regitz E, Held G, Pfreundschuh M. Vitamin D deficiency impairs rituximab-mediated cellular cytotoxicity and outcome of patients with diffuse large B-cell lymphoma treated with but not without rituximab. J Clin Oncol. 2014 Oct 10;32(29):3242-8. doi: 10.1200/JCO.2013.53.4537. Epub 2014 Aug 18.
PMID: 25135997DERIVEDHeld G, Murawski N, Ziepert M, Fleckenstein J, Poschel V, Zwick C, Bittenbring J, Hanel M, Wilhelm S, Schubert J, Schmitz N, Loffler M, Rube C, Pfreundschuh M. Role of radiotherapy to bulky disease in elderly patients with aggressive B-cell lymphoma. J Clin Oncol. 2014 Apr 10;32(11):1112-8. doi: 10.1200/JCO.2013.51.4505. Epub 2014 Feb 3.
PMID: 24493716DERIVEDHorn H, Ziepert M, Becher C, Barth TF, Bernd HW, Feller AC, Klapper W, Hummel M, Stein H, Hansmann ML, Schmelter C, Moller P, Cogliatti S, Pfreundschuh M, Schmitz N, Trumper L, Siebert R, Loeffler M, Rosenwald A, Ott G; German High-Grade Non-Hodgkin Lymphoma Study Group. MYC status in concert with BCL2 and BCL6 expression predicts outcome in diffuse large B-cell lymphoma. Blood. 2013 Mar 21;121(12):2253-63. doi: 10.1182/blood-2012-06-435842. Epub 2013 Jan 18.
PMID: 23335369DERIVEDMuller C, Murawski N, Wiesen MH, Held G, Poeschel V, Zeynalova S, Wenger M, Nickenig C, Peter N, Lengfelder E, Metzner B, Rixecker T, Zwick C, Pfreundschuh M, Reiser M. The role of sex and weight on rituximab clearance and serum elimination half-life in elderly patients with DLBCL. Blood. 2012 Apr 5;119(14):3276-84. doi: 10.1182/blood-2011-09-380949. Epub 2012 Feb 15.
PMID: 22337718DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael G.M. Pfreundschuh, MD
Universitaetsklinikum des Saarlandes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2003
First Posted
January 27, 2003
Study Start
January 1, 2001
Primary Completion
August 5, 2010
Study Completion
August 5, 2010
Last Updated
May 18, 2021
Record last verified: 2021-05