AzTrials
AzTrials

LymphomaPhase 2NCT00290667

Rituximab and Combination Chemotherapy in Treating Older Patients With Previously Untreated B-Cell Lymphoma

A Phase 2 study testing pegfilgrastim, rituximab and cyclophosphamide in people with Lymphoma, run by German High-Grade Non-Hodgkin's Lymphoma Study Group at 338 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 61 to 80 years
Conditions the study is for
Lymphoma
What is being tested?
pegfilgrastim, rituximab and cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
586 participants
Where
338 sitesin 9 countries
Study dates
Feb 2004to Nov 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 61 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histological diagnosis of aggressive B-cell lymphoma
  • Previously untreated disease
  • Stage I-IV disease
  • CD20-positive disease
  • Any International Prognostic Index (IPI) score
  • No secondary lymphoma after prior chemotherapy or radiotherapy
  • No primary CNS lymphoma
  • No primary gastrointestinal (MALT) lymphoma

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • AST and ALT ≤ 3 times normal unless related to lymphoma
  • Bilirubin ≤ 2 mg/dL unless related to lymphoma
  • Creatinine ≤ 2 times normal unless related to lymphoma
  • Fertile patients must use effective contraception
  • No known allergic reactions against foreign proteins
  • No active infections requiring systemically administered antibiotics or antiviral medications
  • No noncompensated heart failure
  • No dilatative cardiomyopathy
  • No coronary heart disease with ST-segment depression in ECG
  • No myocardial infarction during the past 6 months
  • No chronic lung disease with hypoxemia
  • No severe noncompensated hypertension
  • No severe noncompensated diabetes mellitus
  • No clinical signs of cerebral dysfunction
  • No severe psychiatric disease
  • No known HIV infection
  • No active chronic hepatitis B or C infection
  • No other concurrent diseases that exclude the administration of therapy as outlined by the study protocol

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 12 weeks since prior clinical trial participation
  • No prior participation in this study
  • No prior therapy, including murine antibody, for this cancer
  • No prior organ transplantation
  • No concurrent response-adapted radiotherapy ("iceberg radiotherapy")
  • No other concurrent anticancer chemotherapy or other study medication

Trial locations and contacts

338 sites in 9 countries.

314 sites in 9 countries

Germany300 sites

  • Haematologisch Onkologische Praxis

    Aachen, 52070

  • Ostalb-Klinikum Aalen

    Aalen, D-73430

  • Klinikum St. Marien

    Amberg, D-92224

  • Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie

    Ansbach, 91522

  • Specialist Practice for Oncology

    Aschaffenburg, 63739

  • II. Medizinische Klinik

    Aschaffenburg, RG 63739

  • Haematologische Praxis

    Augsburg, 86150

  • Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg

    Augsburg, 86150

  • Klinikum Augsburg

    Augsburg, DOH-86156

  • Kreiskrankenhaus Aurich

    Aurich, 26603

  • Regional Hospital Bad Hersfeld

    Bad Hersfeld, 36251

  • HELIOS Klinikum Bad Saarow

    Bad Saarow, 15526

  • Kreiskrankenhaus Bad Saeckingen

    Bad Säckingen, 79704

  • Internistische Praxis - Bad Salzuflen

    Bad Salzuflen, 32105

  • Onkologische Schwerpunktpraxis und Tagesklinik Dres

    Bad Soden, 65812

  • Ermstalklinik Bad Urach

    Bad Urach, D-72574

  • Klinikum am Bamberg

    Bamberg, 96049

  • Krankenhaus Hohe Warte Mediziniche Klinik

    Bayreuth, 95445

  • Klinikum Bayreuth

    Bayreuth, D-95445

  • Praxis Dr. med. Stefan Korsten

    Bergisch Gladbach, D-51429

  • Onkologisches Versorgungszentrum Friedrichshain

    Berlin, 10249

  • DRK Kliniken Berlin - Koepenick

    Berlin, 12559

  • Internistische Gemeinschaftspraxis - Berlin

    Berlin, 13347

  • Haematologisch-Onkologische Schwerpunktpraxis

    Berlin, 13357

  • Evang. Waldkrankenhaus Spandau

    Berlin, 13589

  • Internistische Gemeinschaftspraxis - Berlin

    Berlin, 14195

  • Charite - Campus Charite Mitte

    Berlin, D-10117

  • Onkolog - Haematolog Schwerpunktpraxis

    Berlin, D-10559

  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, D-12200

  • Vivantes Klinikum Neukoelln

    Berlin, D-12351

  • Robert Roessle Comprehensive Cancer Center - Charite Campus Buch

    Berlin, D-13125

  • Hospital Complex Bernburg

    Bernburg, 06406

  • Franziskus Hospital

    Bielefeld, D-33615

  • Krankenhaus Bietigheim

    Bietigheim, 74319

  • Saint Agnes Hospital

    Bocholt, DOH-463974290

  • Augusta-Kranken-Anstalt gGmbH

    Bochum, D-44791

  • St. Josef-Hospital - Bochum

    Bochum, D-44791

  • Knappschaftskrankenhaus Bochum-Langendreer

    Bochum, D-44892

  • Johanniter-Krankenhaus Bonn

    Bonn, 53113

  • Universitaetsklinikum Bonn

    Bonn, D-53105

  • Medizinische Poliklinik

    Bonn, D-53111

  • Praxis fuer Haematologie und Internistische Onkologie - Borken

    Borken, 46325

  • Knappschaftskrankenhaus Bottrop

    Bottrop, D-46242

  • Hamatologische Sprechstunde

    Brandenburg, 14770

  • Staedtisches Klinikum Braunschweig

    Braunschweig, G-38114

  • Praxis Dres. F.& G. Doering

    Bremen, 28209

  • Klinikum Bremen-Mitte

    Bremen, D-28205

  • DIAKO Ev. Diakonie Krankenhaus gGmbH

    Bremen, D-28239

  • St. Joseph Hospital

    Bremerhaven, D-27568

  • Zentralkrankenhaus

    Bremerhaven, N 27574

  • Medizinische Klinik am Lukas - Krankenhaus

    Bünde, 32257

  • Praxis fuer Haematologie und Onkologie - Burgwedel

    Burgwedel, 30938

  • General Hospital

    Celle, 29223

  • Onkologische Schwerpunktpraxis Celle

    Celle, D-29221

  • Hospital Kuchwald Chemnitz

    Chemnitz, D-09113

  • Klinikum Coburg

    Coburg, 96450

  • Internistische Praxis - Coesfeld

    Coesfeld, 48653

  • Praxis Internistischer Onkologie und Haematologie - Koeln

    Cologne, 50674

  • Kliniken der Stadt Koeln gGmbH - Krankenhaus Holweide

    Cologne, 51067

  • Praxis fuer Onkologie - Kalk

    Cologne, 51105

  • Praxis Fuer Haematologie Internistische Onkologie

    Cologne, D-50677

  • Medizinische Universitaetsklinik I at the University of Cologne

    Cologne, D-50924

  • Lung Clinic Cologne-Merheim

    Cologne-Merheim, D-51109

  • Carl - Thiem - Klinkum Cottbus

    Cottbus, D-03048

  • Praxis Dr. Rheinhold Siegmund - Dr. Matthias Penke

    Damme, D-49401

  • Klinikum Darmstadt

    Darmstadt, D-64283

  • Staedtisches Klinikum Dessau

    Dessau, 06822

  • Internistische Praxis

    Detmold, 32756

  • Saint Johannes Hospital Dortmund

    Dortmund, 44137

  • Klinikum Dortmund

    Dortmund, D-44137

  • Universitatsklinikum Carl Gustav Carus

    Dresden, D-01307

  • Johanniter-Krankenhaus Rheinhausen GmbH

    Duisburg, 47228

  • St. Johannes Hospital - Medical Klinik II

    Duisburg, D-47166

  • Franz Hospital Dulmen

    Dülmen, 48249

  • Florence-Nightingale-Krankenhause, Deaconess Kaiserswerth

    Düsseldorf, 40489

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, D-40225

  • Klinikum Barnim GmbH, Werner Forssmann Krankenhaus

    Eberswalde, 16225

  • Virngrund-Klinik Ellwangen

    Ellwangen, 73479

  • Hans - Susemihl - Krankenhaus

    Emden, 26721

  • Helios Klinikum Erfurt

    Erfurt, 99089

  • Medizinische Klinik III - Universitaetsklinikum Erlangen

    Erlangen, D-91054

  • St. Antonius Hospital

    Eschweiler, DOH-52249

  • Universitaetsklinikum Essen

    Essen, D-45122

  • Evangelisches Krankenhaus Essen Werden

    Essen, D-45239

  • Staedtische Kliniken Esslingen

    Esslingen am Neckar, D-73730

  • Schwerpunktpraxis fuer Haematologie und Onkologie - Flensburg

    Flensburg, 24939

  • Gemeinschaftspraxis fuer Internistische - Frankenthal

    Frankenthal, 67227

  • Onkologie Bethanien

    Frankfurt, D-60389

  • Krankenhaus Nordwest

    Frankfurt, D-60488

  • Klinikum der J.W. Goethe Universitaet

    Frankfurt, D-60590

  • Klinikum Frankfurt (Oder) GmbH

    Frankfurt (Oder), D-15236

  • St. Marienkrankenhaus - Frankfurt am Main

    Frankfurt am Main, 60318

  • Praxis Internistischer Onkologie und Haematologie - Frechen

    Frechen, 50226

  • Gemeinschaftspraxis - Freiburg

    Freiburg im Breisgau, 79098

  • Evang. Deaconess Hospital Freiburg

    Freiburg im Breisgau, 79110

  • Praxis fur Interdisziplinaere Onkologie

    Freiburg im Breisgau, D-79106

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, D-79106

  • Municipal Hospital Complex

    Fulda, 36043

  • Klinikum Garmisch - Partenkirchen GmbH

    Garmisch-Partenkirchen, D-82467

  • Robert - Koch Hospital

    Gehrden, 30989

  • Saint Josef Hospital

    Gelsenkirchen, D-45899

  • Internistische Praxisgemeinschaft

    Germering, 82110

  • Centre for Internal Medicine Giessen

    Giessen, 35392

  • Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie

    Giessen, 35392

  • Wilhelm-Anton-Hospital gGmbH, Goch

    Goch, D-47574

  • Staedtisches Klinikum Görlitz GmbH

    Görlitz, 02828

  • DR Herbert - Nieper Krankenhaus Goslar

    Goslar, 38642

  • Universitaetsklinikum Göttingen

    Göttingen, D-37075

  • Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

    Greifswald, 17487

  • Kreiskrankenhaus Gummersbach GMBH

    Gummersbach, D-51643

  • Internistisch-Haematologische Gemeinschaftspraxis - Gustrow

    Güstrow, 18273

  • Staedtisches Klinikum Gütersloh

    Gütersloh, D-33332

  • Allgemeines Krankenhaus Hagen

    Hagen, D-58095

  • St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

    Hagen, D-58095

  • St. Salvator Krankenhaus

    Halberstadt, D 38820

  • Internistische Gemeinschaftspraxis - Halle

    Halle, 06110

  • Universitaetsklinikum Halle

    Halle, D-06097

  • Krankenhaus St. Elisabeth und St. Barbara

    Halle, D-06110

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH

    Halle, D-06120

  • St. Sixtus Hospital

    Haltern, D-45721

  • Praxis fuer Innere Medizin - Bergedorf

    Hamburg, 21029

  • Marienkrankenhaus

    Hamburg, 22087

  • Allgemeines Krankenhaus Altona

    Hamburg, 22763

  • Onkologische Schwerpunktpraxis Dr. med. Verpoort, PD Dr. med. Zeller and Dr. med. Wierecky

    Hamburg, D-20095

  • Asklepios Klinik St. Georg

    Hamburg, D-20099

  • University Medical Center Hamburg - Eppendorf

    Hamburg, D-20246

  • Asklepios Klinik Nord Heidberg

    Hamburg, D-22417

  • Haematologisch-Onkologische Praxis Altona

    Hamburg, D-22767

  • St. Marien Hospital

    Hamm, 59065

  • Evangelische Krankenhaus Hamm

    Hamm, D-59063

  • Klinikum Stadt Hanau

    Hanau, 63450

  • Schwerpunktpraxis Haematologie/Onkologie - Hannover

    Hanover, 30169

  • Krankenhaus Siloah - Medizinische Klinik II

    Hanover, D-30449

  • Henriettenstiftung Frauenklinik

    Hanover, D-30559

  • Medizinische Hochschule Hannover

    Hanover, D-30625

  • Oncology Specialists Clinic

    Harrislee, D-24955

  • Ruprecht - Karls - Universitaet Heidelberg

    Heidelberg, D-69117

  • Thoraxklinik Heidelberg

    Heidelberg, D-69126

  • Regional Hospital Heidenheim

    Heidenheim, 89522

  • Regional Hospital Am Plattenwald Bad Friedrichshall

    Heilbronn, 74177

  • Klinikum Herford

    Herford, D-32049

  • Marienhospital at Ruhr University Bochum

    Herne, D-44625

  • Privatklinik Dr. R. Schindlbeck GmbH & Co. KG

    Herrsching am Ammersee, D-82211

  • Onkologische Schwerpunktpraxis

    Hildesheim, D-31134

  • St. Bernward Krankenhaus

    Hildesheim, D-31134

  • Staedtisches Krankenhaus Hildesheim

    Hildesheim, D-31134

  • Evang. Hospital

    Holzminden, 37603

  • Haematologie und Internistische Onkologie Praxis

    Homberg (Efze), D-34576

  • Universitaetsklinikum des Saarlandes

    Homburg, D-66424

  • Hospital Complex Hoyerswerda

    Hoyerswerda, 02977

  • Clinic for Bone Marrow Transplantation and Hematology and Oncology

    Idar-Oberstein, D-55743

  • Internistische Gemeinschaftspraxis - Jena

    Jena, 07743

  • Klinikum der Friedrich-Schiller Universitaet Jena

    Jena, 07747

  • Onkologische Gemeinschaftspraxis - Kaiserslautern

    Kaiserslautern, 67655

  • Westpfalz-Klinikum GmbH

    Kaiserslautern, D-67653

  • Staedtisches Klinikum Karlsruhe gGmbH

    Karlsruhe, 76133

  • St. Vincentius - Kliniken

    Karlsruhe, D-76137

  • Red Cross Hospital Kassel

    Kassel, 34121

  • Internistische Gemeinschaftspraxis - Kassel

    Kassel, D-34117

  • Klinikum Kempten Oberallgaeu

    Kempten, D-87439

  • Staedtisches Krankenhaus Kiel

    Kiel, 23116

  • Praxis fuer Haematologie und Onkologie

    Koblenz, D-56068

  • Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH

    Koblenz, D-56068

  • Leonardis Clinic

    Kornwestheim, D-70806

  • Haematologische / Onkologische Schwerpunktpraxis

    Krefeld, 47798

  • Klinikum Krefeld GmbH

    Krefeld, D-47805

  • Internistische Onkologische Praxis - Kronach

    Kronach, 96317

  • Frankenwald Klinik

    Kronach, D-96317

  • Internistische Praxis - Landshut

    Landshut, 84028

  • Klinikum Landshut

    Landshut, 84034

  • Caritas - Krakenhaus Lebach

    Lebach, 66822

  • Onkologische Schwerpunktpraxis - Leer

    Leer, D-26789

  • Praxis fuer Onkologie am Diakonissenhaus

    Leipzig, 04179

  • Forschungsgesellschaft mbH

    Leipzig, 04289

  • Gemeinschaftspraxis fuer Dres. Aldaoud und Schwarzer

    Leipzig, 04289

  • University Leipzig Clinic of Internal Medicine

    Leipzig, D-04103

  • Klinikum "St. Georg" Leipzig

    Leipzig, D-04129

  • Klinikum Lippe - Lemgo

    Lemgo, D-32657

  • St. Vincenz Hospital Limburg

    Limburg, D-65549

  • St. Bonifatius Hospital Lingen

    Lingen, D-49808

  • Dreifaltigkeits Hospital

    Lippstadt, D-59555

  • Kreiskrankenhaus Loerrach

    Loerrach, 79539

  • Onkologische Schwerpunktpraxis

    Loerrach, D-79539

  • Schwerpunktpraxis fuer Haematologie und Onkologie - Luebeck

    Lübeck, 23562

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lübeck, D-23538

  • Sana Kliniken Luebeck

    Lübeck, D-23560

  • Kreiskrankenhaus Luedenscheid

    Lüdenscheid, 58515

  • Klinikum Ludwigsburg

    Ludwigsburg, D-71640

  • St. Marien Hospital Ludwighafen

    Ludwigshafen, D-67067

  • Klinikum der Stadt Ludwigshafen am Rhein

    Ludwigshafen am Rhein, D-67063

  • Universitatsklinikum der MA

    Magdeburg, 39120

  • Staedtisches Klinikum Magdeburg - Altstadt

    Magdeburg, D-39002

  • Internistische Gemeinschaftspraxis - Magdeburg

    Magdeburg, D-39104

  • St. Vincenz und Elisabeth Hospital

    Mainz, 55131

  • Johannes Gutenberg University

    Mainz, D-55101

  • Gemeinschaftspraxis

    Mannheim, D-68161

  • III Medizinische Klinik Mannheim

    Mannheim, D-68305

  • Schwerpunktpraxis Internist Onkologie - Marburg

    Marburg, 35057

  • Universitaetsklinikum Giessen und Marburg GmbH - Marburg

    Marburg, D-35043

  • Regional Hospital Mayen

    Mayen, D-56727

  • Gemeinschaftspraxis Dres. med. Ellbrueck/Goeller/Kraenzle/Niedermeier/Jocham

    Memmingen, 87700

  • Krankenhaus Ludmillenstift

    Meppen, 49716

  • Gemeinschaftspraxis - Minden

    Minden, 32427

  • Klinikum Minden

    Minden, D-32423

  • Ev. Hospital Bethesda

    Mönchengladbach, D-41061

  • Krankenhaus Maria Hilf GmbH

    Mönchengladbach, D-41063

  • Haematologische Praxis - Moenchengladbach

    Mönchengladbach, D-41239

  • Evangelisches Krankenhaus - Muelheim

    Mülheim, 45466

  • St. Marien Hospital - Muelheim an der Ruhr

    Mülheim, D-45468

  • Kreiskrankenhaus Muenchberg

    Münchberg, D-95213

  • Universitaets - Kinderpoliklinik

    Munich, 80336

  • Krankenhaus Muenchen Schwabing

    Munich, 80804

  • Munich Oncologic Practice at Elisenhof

    Munich, D-80335

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377

  • Staedtisches Krankenhaus Muenchen - Harlaching

    Munich, D-81545

  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen

    Munich, D-81675

  • Municipal Hospital Munich

    Munich, D-81737

  • Gemeinschaftspraxis - Muenster

    Münster, 48145

  • Haematologisch - Onkologische Gemeinschaftspraxis - Muenster

    Münster, D-48149

  • Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster

    Münster, D-48149

  • Klinikum Schwaebisch Gmuend Stauferklinik

    Mutlangen, D-73557

  • Staedtisches Krankenhaus Nettetal GmbH

    Nettetal, 41334

  • Klinikum Neubrandenburg

    Neubrandenburg, 17036

  • Onkologische Schwerwpunktpraxis Dr. Ladda

    Neumarkt, D-92318

  • Regional Hospital Neumarkt

    Neumarkt, D-92318

  • Onkologische Schwerpunktpraxis Dr. Schmidt

    Neunkirchen, D-66538

  • Staedtisches Klinikum Neunkirchen gGmbH

    Neunkirchen, D-66538

  • Internistische Praxis - Neuss

    Neuss, 41460

  • Lukaskrankenhaus Neuss

    Neuss, D-41464

  • DRK Krankenhaus Neuwied

    Neuwied, 56564

  • Praxis fuer Haematologie und Interne Onkologie

    Norderstedt, 22844

  • Gemeinschaftspraxis fuer Onkologie - Nordhorn

    Nordhorn, 48527

  • Gemeinschaftspraxis fuer Haematologie - Northeim

    Northeim, 37154

  • Praxisklinik fuer Innere Medizin - Nuernberg

    Nuremberg, 90449

  • Klinikum Nuernberg - Klinikum Nord

    Nuremberg, D-90419

  • Schlossbergkliniken Oberstaufen

    Oberstaufen, D-87534

  • Internistische Gemeinschaftspraxis - Offenbach

    Offenbach, D-63065

  • Klinikum Offenburg

    Offenburg, D-77654

  • Pius Hospital - Oldenburg

    Oldenburg, 26121

  • Internistische Gemeinschaftspraxis - Oldenburg

    Oldenburg, D-26121

  • Ev. Hospital Oldenburg

    Oldenburg, D-26122

  • Klinikum Oldenburg

    Oldenburg, D-26133

  • St. Martinus Hospital - Olpe

    Olpe, 57462

  • Marien Hospital

    Osnabrück, D-49074

  • Klinikum Osnabrück GmbH

    Osnabrück, D-49076

  • Paracelsus - Klinik Osnabrück

    Osnabrück, D-49076

  • Bruederkrankenhaus St. Josef Paderborn

    Paderborn, D-33098

  • Asklepios Klinik - Parchim

    Parchim, 19370

  • Staedtisches Krankenhaus

    Pforzheim, 75175

  • Krankenhaus Siloah - Pforzheim

    Pforzheim, 75179

  • Praxis fuer Innere Medizin am Krankenhaus Siloah - Pforzheim

    Pforzheim, 75179

  • Gemeinschaftspraxis - Pinneberg

    Pinneberg, 25421

  • Klinikum Ernst Von Bergmann

    Potsdam, D-14467

  • Kreiskrankenhaus Radebeul

    Radebeul, D-01445

  • Gemeinschaftspraxis - Ravensburg

    Ravensburg, 88212

  • Krankenhaus St. Elisabeth - Ravensburg

    Ravensburg, D-88212

  • Elisabeth Krankenhaus

    Recklinghausen, 45661

  • Prosper-Hospital Recklinghausen

    Recklinghausen, DOH-45659

  • Hematologische Onkologische Praxis

    Regensburg, 93047

  • Klinikum der Universitaet Regensburg

    Regensburg, D-93042

  • Krankenhaus Barmherzige Brueder Regensburg

    Regensburg, D-93049

  • Internistische Praxis Dres. Hempel und Hochdorfer

    Rehling, 86508

  • Klinikum Remscheid GmbH

    Remscheid, D-42859

  • Jakobi Krankenhaus

    Rheine, 48431

  • Haematologische/Onkologische Schwerpunktpraxis - Rostock

    Rostock, 18057

  • Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock

    Rostock, D-18055

  • Klinikum Suedstadt Rostock

    Rostock, D-18059

  • Diakonie - Krankenhaus

    Rotenburg (Wümme), DOH-27356

  • Internistische Schwerpunktpraxis

    Rüsselsheim am Main, 65428

  • Gemeinschaftspraxis - Saarbruecken

    Saarbrücken, 66113

  • Caritasklinik St. Theresia

    Saarbrücken, D-66113

  • St. Elizabeth-Klinik Saarlouis

    Saarlouis, D-66713

  • Martin - Luther Hospital

    Schleswig, D-24837

  • Praxis fur Innere Medizin - Schmiedeberg

    Schmiedeberg, 01762

  • Deaconess Hospital

    Schwäbisch Hall, D-74523

  • Gemeinschaftspraxis fuer Haematologie und Internist - Schweinfurt

    Schweinfurt, 97421

  • Leopoldina - Krankenhaus

    Schweinfurt, D-97422

  • HELIOS Klinikum - Schwelm

    Schwelm, 58332

  • Klinikum Schwerin

    Schwerin, D-19049

  • St. Marien - Krankenhaus Siegen GMBH

    Siegen, D-57072

  • Evang. Jung-Stilling Hospital

    Siegen, D-57074

  • St. Lukas - Clinic Solingen

    Solingen, D-42697

  • Krankenhaus Maria-Hilf - Stadtlohn

    Stadtlohn, 48703

  • Onkologische Schwerpunktpraxis - Straubing

    Straubing, 94315

  • Hospital Bad Cannstatt

    Stuttgart, 70374

  • Haematologische Praxis

    Stuttgart, D-70173

  • Klinik fuer Onkologie - Katharinenhospital Stuttgart

    Stuttgart, D-70174

  • Diakonie Klinikum Stuttgart

    Stuttgart, D-70176

  • Gastroenterologische und Haematologisch-Onkologische Praxis E. M. Dr. Hoering von Ehr Respondek

    Stuttgart, D-70176

  • Klinikum Stuttgart - Buergerhospital

    Stuttgart, D-70191

  • Robert-Bosch-Krankenhaus

    Stuttgart, D-70376

  • St. Elisabeth Hospital Thuine

    Thuine, D-49832

  • Regional Hospital Traunstein

    Traunstein, D-83278

  • Onkologische Gemeinschaftspraxis - Trier

    Trier, 54290

  • Krankenanstalt Mutterhaus der Borromaerinnen

    Trier, D-54219

  • Krankenhaus Der Barmherzigen Brueder

    Trier, D-54292

  • Praxis Fuer Internistische Haematologie / Onkologie

    Troisdorf, 53840

  • Universitaetsklinikum Tuebingen

    Tübingen, D-72076

  • Hospital Tutzing

    Tutzing, D-82327

  • Praxis fuer Haematologie und Onkologie

    Twistringen, D-27239

Other trials in Germany

Switzerland6 sites

  • Kantonsspital Aarau

    Aarau, CH-5001

  • Universitaets-Kinderspital beider Basel

    Basel, CH-4005

  • Ospedale "la Carita", Locarno

    Locarno, 6600

  • Kinderspital Luzern

    Lucerne, CH-6000

  • Ostschweizer Kinderspital

    Sankt Gallen, CH-9006

  • University Children's Hospital

    Zurich, CH-8032

Other trials in Switzerland

Czechia2 sites

  • University Hospital Brno

    Brno, CZ-662 63

  • Charles University Hospital

    Prague, CZ-150 06

Other trials in Czechia

France1 site

  • Hopital Debrousse

    Lyon, 69322

Other trials in France

Italy1 site

  • Azienda Ospedaliera di Padova

    Padova, 35128

Other trials in Italy

Netherlands1 site

  • Erasmus MC - Sophia Children's Hospital

    Rotterdam, 3015 GJ

Other trials in Netherlands

Poland1 site

  • Akademia Medyczna im. Piastow Slaskich

    Wroclaw, 50-367

Other trials in Poland

Sweden1 site

  • Goeteborg University

    Gothenburg, S-141685

Other trials in Sweden

United Kingdom1 site

  • Royal Manchester Children's Hospital

    Manchester, England, M27 4HA

Other trials in United Kingdom

About this study

Official title: 2-Weekly CHOP Chemotherapy With Dose-Dense Rituximab for the Treatment of Patients Aged 61 to 80 Years With Aggressive CD-20 Positive B-Cell Lymphomas: A Phase-II/Pharmacokinetic Study (CHOP-R-ESC)

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.

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with previously untreated B-cell lymphoma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine a pharmacokinetic profile for pharmacokinetics-based or rituximab within a CHOP-14 regimen comprising cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone in elderly patients with previously untreated aggressive B-cell lymphoma.
  • To determine whether increased single-doses of rituximab for males can compensate their lower serum levels.
  • Evaluate the safety and toxicity profile of this regimen in male patients.

Secondary

  • Determine the rate of complete responses, primary progressions under therapy, event-free survival, progression-free survival, and overall survival in patients treated with this regimen.
  • Determine the rate of primary progression in patients treated with this regimen.

OUTLINE: This is a multicenter study. All patients undergo the following treatment.

  • Prephase treatment: Patients receive vincristine subcutaneously on day -6 and oral prednisone on days -6 to 0.
  • Immunochemotherapy and radiotherapy: Patients receive CHOP chemotherapy comprising cyclophosphamide IV over 15 minutes, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Patients also receive pegfilgrastim subcutaneously on days 4, 18, 32, 46, 60, and 74. Treatment with CHOP chemotherapy repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who show no response after course 4 of CHOP chemotherapy proceed to salvage chemotherapy off study.

Patients are evaluated 2-4 weeks after completion of CHOP. Patients with initial bulky disease (i.e., diameter ≥ 7.5 cm) or extranodal involvement AND achieving complete remission (CR), unconfirmed CR (CRu), or partial remission undergo radiotherapy 5 days a week for 4 weeks. Patients who do not achieve CR or CRu 2 months after completion of radiotherapy proceed to salvage chemotherapy off study.

Patients are then stratified according to center, International Prognostic Index (1-2 vs 3-5), disease involvement (bulky vs extranodal vs bulky and/or extranodal), age (61-70 years old vs 71-80 years old), and gender. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (2-weekly rituximab): Patients receive rituximab IV 375 mg/m^2 (females) and 500 mg/m^2 (males) over 4 hours on days 0, 14, 28, 42, 56, 70, 84, and 98. Patients also receive pegfilgrastim subcutaneously on day 4 of each course.
  • Arm II (pharmacokinetic-based dose-dense rituximab): Patients receive rituximab IV 375 mg/m^2 (females) and 500 mg/m^2 (males) over 4 hours on days -1, 0, 3, 7, 14, 21, 28, and 42. Patients also receive pegfilgrastim subcutaneously on day 4 of each course.

Some patients undergo blood sample collection periodically during and after treatment for pharmacokinetic studies.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then once a year therafter.

Conditions
Lymphoma
Keywords
contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse 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, stage III adult immunoblastic large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, contiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult Burkitt lymphoma, stage I adult Burkitt lymphoma, stage III adult Burkitt lymphoma, stage IV adult Burkitt lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, stage I adult diffuse mixed cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage IV adult diffuse mixed cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Burkitt Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00290667
Study groupRoleWhat they receive
Interventional: CHOP-14 + 8 x 2-weekly rituximabActive comparatorArm I (2-weekly rituximab): Patients receive rituximab IV 375 mg/m^2 (females) and 500 mg/m^2 (males) over 4 hours on days 0, 14, 28, 42, 56, 70, 84, and 98. Patients also receive pegfilgrastim subcutaneously on day 4 of each course.
Receives: Biological: pegfilgrastim; Biological: rituximab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisone; Drug: vincristine sulfate; Other: pharmacological study; Radiation: radiation therapy
Interventional: CHOP-14 + 8 x dose-dense rituximabActive comparatorArm II (pharmacokinetic-based dose-dense rituximab): Patients receive rituximab IV 375 mg/m^2 (females) and 500 mg/m^2 (males) over 4 hours on days -1, 0, 3, 7, 14, 21, 28, and 42. Patients also receive pegfilgrastim subcutaneously on day 4 of each course.
Receives: Biological: pegfilgrastim; Biological: rituximab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisone; Drug: vincristine sulfate; Other: pharmacological study; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics (in first 20 patients of each cohort with a distinct variation of the rituximab schedule) assessed on days -4, -1, 10, 29, 57, 99, 155, 239, 267, 295, 407, and 491 of treatment

    Measured: -4 to 491 days of treatment

  2. Safety and treatment related deaths at 3 months after study completion

    Measured: 3 months after study completion

  3. Toxicity assessed by NCI criteria, adverse events, serious adverse events, protocol adherence, and treatment-related deaths at 3 months after study completion

    Measured: 3 months after study completion

Secondary outcomes (5)

  1. Time to treatment failure assessed at 2 years within the study and periodically thereafter

    Measured: at 2 years within the study and periodically thereafterlif

  2. Complete response rate assessed at 2 years within the study and periodically thereafter

    Measured: at 2 years within the study and periodically thereafter

  3. Progression rate

    Measured: life-long

  4. Survival time

    Measured: life-long

  5. Progression-free survival

    Measured: life-long

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2006 (estimated)
  2. Study startFeb 2004
  3. Primary completionDec 2013
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
586 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00290667
Sponsor's protocol ID
CDR0000454505
Other IDs
DSHNHL-2004-1, EU-20536, DSHNHL-CHOP-R-ESC, EUDRACT-2005-00529-68
Status last verified
May 2021
First submitted
9 Feb 2006
Last updated
18 May 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pegfilgrastim, rituximab and cyclophosphamide in people with Lymphoma, run by German High-Grade Non-Hodgkin's Lymphoma Study Group at 338 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 338 sites in Germany, Switzerland, Czechia, France, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (in first 20 patients of each cohort with a distinct variation of the rituximab schedule) assessed on days -4, -1, 10, 29, 57, 99, 155, 239, 267, 295, 407, and 491 of treatment (time frame: -4 to 491 days of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00290667.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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