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

Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00290667
• Other study ID #: CDR0000454505
• Secondary ID: DSHNHL-2004-1EU-
• Status: Completed
• Phase: Phase 2
• Start date: February 2004
• Est. completion date: November 2015

Study information

• Verified date: May 2021
• Source: Universität des Saarlandes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 586
• Est. completion date: November 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 61 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

Biological:
• pegfilgrastim

• rituximab

Drug:
• cyclophosphamide

• doxorubicin hydrochloride

• prednisone

• vincristine sulfate

Other:
• pharmacological study

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Czechia	University Hospital Brno	Brno
Czechia	Charles University Hospital	Prague 5
France	Hopital Debrousse	Lyon
Germany	Haematologisch Onkologische Praxis	Aachen
Germany	Ostalb-Klinikum Aalen	Aalen
Germany	Klinikum St. Marien	Amberg
Germany	Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie	Ansbach
Germany	II. Medizinische Klinik	Aschaffenburg
Germany	Specialist Practice for Oncology	Aschaffenburg
Germany	Haematologische Praxis	Augsburg
Germany	Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg	Augsburg
Germany	Klinikum Augsburg	Augsburg
Germany	Kreiskrankenhaus Aurich	Aurich
Germany	Regional Hospital Bad Hersfeld	Bad Hersfeld
Germany	HELIOS Klinikum Bad Saarow	Bad Saarow
Germany	Kreiskrankenhaus Bad Saeckingen	Bad Säckingen
Germany	Internistische Praxis - Bad Salzuflen	Bad Salzuflen
Germany	Onkologische Schwerpunktpraxis und Tagesklinik Dres	Bad Soden
Germany	Ermstalklinik Bad Urach	Bad Urach
Germany	Klinikum am Bamberg	Bamberg
Germany	Klinikum Bayreuth	Bayreuth
Germany	Krankenhaus Hohe Warte Mediziniche Klinik	Bayreuth
Germany	Praxis Dr. med. Stefan Korsten	Bergisch Gladbach
Germany	Charite - Campus Charite Mitte	Berlin
Germany	Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin	Berlin
Germany	DRK Kliniken Berlin - Koepenick	Berlin
Germany	Evang. Waldkrankenhaus Spandau	Berlin
Germany	Haematologisch-Onkologische Schwerpunktpraxis	Berlin
Germany	Internistische Gemeinschaftspraxis - Berlin	Berlin
Germany	Internistische Gemeinschaftspraxis - Berlin	Berlin
Germany	Onkolog - Haematolog Schwerpunktpraxis	Berlin
Germany	Onkologisches Versorgungszentrum Friedrichshain	Berlin
Germany	Robert Roessle Comprehensive Cancer Center - Charite Campus Buch	Berlin
Germany	Vivantes Klinikum Neukoelln	Berlin
Germany	Hospital Complex Bernburg	Bernburg
Germany	Franziskus Hospital	Bielefeld
Germany	Krankenhaus Bietigheim	Bietigheim
Germany	Saint Agnes Hospital	Bocholt
Germany	Augusta-Kranken-Anstalt gGmbH	Bochum
Germany	Knappschaftskrankenhaus Bochum-Langendreer	Bochum
Germany	St. Josef-Hospital - Bochum	Bochum
Germany	Johanniter-Krankenhaus Bonn	Bonn
Germany	Medizinische Poliklinik	Bonn
Germany	Universitaetsklinikum Bonn	Bonn
Germany	Praxis fuer Haematologie und Internistische Onkologie - Borken	Borken
Germany	Knappschaftskrankenhaus Bottrop	Bottrop
Germany	Hamatologische Sprechstunde	Brandenburg
Germany	Staedtisches Klinikum Braunschweig	Braunschweig
Germany	DIAKO Ev. Diakonie Krankenhaus gGmbH	Bremen
Germany	Klinikum Bremen-Mitte	Bremen
Germany	Praxis Dres. F.& G. Doering	Bremen
Germany	St. Joseph Hospital	Bremerhaven
Germany	Zentralkrankenhaus	Bremerhaven
Germany	Medizinische Klinik am Lukas - Krankenhaus	Bünde
Germany	Praxis fuer Haematologie und Onkologie - Burgwedel	Burgwedel
Germany	General Hospital	Celle
Germany	Onkologische Schwerpunktpraxis Celle	Celle
Germany	Hospital Kuchwald Chemnitz	Chemnitz
Germany	Klinikum Coburg	Coburg
Germany	Internistische Praxis - Coesfeld	Coesfeld
Germany	Kliniken der Stadt Koeln gGmbH - Krankenhaus Holweide	Cologne
Germany	Medizinische Universitaetsklinik I at the University of Cologne	Cologne
Germany	Praxis Fuer Haematologie Internistische Onkologie	Cologne
Germany	Praxis fuer Onkologie - Kalk	Cologne
Germany	Praxis Internistischer Onkologie und Haematologie - Koeln	Cologne
Germany	Lung Clinic Cologne-Merheim	Cologne-Merheim
Germany	Carl - Thiem - Klinkum Cottbus	Cottbus
Germany	Praxis Dr. Rheinhold Siegmund - Dr. Matthias Penke	Damme
Germany	Klinikum Darmstadt	Darmstadt
Germany	Staedtisches Klinikum Dessau	Dessau
Germany	Internistische Praxis	Detmold
Germany	Klinikum Dortmund	Dortmund
Germany	Saint Johannes Hospital Dortmund	Dortmund
Germany	Universitatsklinikum Carl Gustav Carus	Dresden
Germany	Universitaetsklinikum Duesseldorf	Duesseldorf
Germany	Johanniter-Krankenhaus Rheinhausen GmbH	Duisburg
Germany	St. Johannes Hospital - Medical Klinik II	Duisburg
Germany	Franz Hospital Dulmen	Dulmen
Germany	Florence-Nightingale-Krankenhause, Deaconess Kaiserswerth	Dusseldorf
Germany	Klinikum Barnim GmbH, Werner Forssmann Krankenhaus	Eberswalde
Germany	Virngrund-Klinik Ellwangen	Ellwangen
Germany	Hans - Susemihl - Krankenhaus	Emden
Germany	Helios Klinikum Erfurt	Erfurt
Germany	Medizinische Klinik III - Universitaetsklinikum Erlangen	Erlangen
Germany	St. Antonius Hospital	Eschweiler
Germany	Evangelisches Krankenhaus Essen Werden	Essen
Germany	Universitaetsklinikum Essen	Essen
Germany	Staedtische Kliniken Esslingen	Esslingen
Germany	Schwerpunktpraxis fuer Haematologie und Onkologie - Flensburg	Flensburg
Germany	Gemeinschaftspraxis fuer Internistische - Frankenthal	Frankenthal
Germany	Klinikum der J.W. Goethe Universitaet	Frankfurt
Germany	Krankenhaus Nordwest	Frankfurt
Germany	Onkologie Bethanien	Frankfurt
Germany	Klinikum Frankfurt (Oder) GmbH	Frankfurt (Oder)
Germany	St. Marienkrankenhaus - Frankfurt am Main	Frankfurt am Main
Germany	Praxis Internistischer Onkologie und Haematologie - Frechen	Frechen
Germany	Evang. Deaconess Hospital Freiburg	Freiburg
Germany	Gemeinschaftspraxis - Freiburg	Freiburg
Germany	Praxis fur Interdisziplinaere Onkologie	Freiburg
Germany	Universitaetsklinikum Freiburg	Freiburg
Germany	Municipal Hospital Complex	Fulda
Germany	Klinikum Garmisch - Partenkirchen GmbH	Garmisch-Partenkirchen
Germany	Robert - Koch Hospital	Gehrden
Germany	Saint Josef Hospital	Gelsenkirchen
Germany	Internistische Praxisgemeinschaft	Germering
Germany	Centre for Internal Medicine Giessen	Giessen
Germany	Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie	Giessen
Germany	Wilhelm-Anton-Hospital gGmbH, Goch	Goch
Germany	Staedtisches Klinikum Görlitz GmbH	Görlitz
Germany	DR Herbert - Nieper Krankenhaus Goslar	Goslar
Germany	Universitaetsklinikum Göttingen	Göttingen
Germany	Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet	Greifswald
Germany	Kreiskrankenhaus Gummersbach GMBH	Gummersbach
Germany	Internistisch-Haematologische Gemeinschaftspraxis - Gustrow	Gustrow
Germany	Staedtisches Klinikum Gütersloh	Gütersloh
Germany	Allgemeines Krankenhaus Hagen	Hagen
Germany	St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH	Hagen
Germany	St. Salvator Krankenhaus	Halberstadt
Germany	Internistische Gemeinschaftspraxis - Halle	Halle
Germany	Krankenhaus Martha-Maria Halle-Doelau gGmbH	Halle
Germany	Krankenhaus St. Elisabeth und St. Barbara	Halle
Germany	Universitaetsklinikum Halle	Halle
Germany	St. Sixtus Hospital	Haltern
Germany	Allgemeines Krankenhaus Altona	Hamburg
Germany	Asklepios Klinik Nord Heidberg	Hamburg
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Haematologisch-Onkologische Praxis Altona	Hamburg
Germany	Marienkrankenhaus	Hamburg
Germany	Onkologische Schwerpunktpraxis Dr. med. Verpoort, PD Dr. med. Zeller and Dr. med. Wierecky	Hamburg
Germany	Praxis fuer Innere Medizin - Bergedorf	Hamburg
Germany	University Medical Center Hamburg - Eppendorf	Hamburg
Germany	Evangelische Krankenhaus Hamm	Hamm
Germany	St. Marien Hospital	Hamm
Germany	Klinikum Stadt Hanau	Hanau
Germany	Henriettenstiftung Frauenklinik	Hannover
Germany	Krankenhaus Siloah - Medizinische Klinik II	Hannover
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Schwerpunktpraxis Haematologie/Onkologie - Hannover	Hannover
Germany	Oncology Specialists Clinic	Harrislee
Germany	Ruprecht - Karls - Universitaet Heidelberg	Heidelberg
Germany	Thoraxklinik Heidelberg	Heidelberg
Germany	Regional Hospital Heidenheim	Heidenheim
Germany	Regional Hospital Am Plattenwald Bad Friedrichshall	Heilbronn
Germany	Klinikum Herford	Herford
Germany	Marienhospital at Ruhr University Bochum	Herne
Germany	Privatklinik Dr. R. Schindlbeck GmbH & Co. KG	Herrsching Am Ammersee
Germany	Onkologische Schwerpunktpraxis	Hildesheim
Germany	St. Bernward Krankenhaus	Hildesheim
Germany	Staedtisches Krankenhaus Hildesheim	Hildesheim
Germany	Evang. Hospital	Holzminden
Germany	Haematologie und Internistische Onkologie Praxis	Homberg
Germany	Universitaetsklinikum des Saarlandes	Homburg
Germany	Hospital Complex Hoyerswerda	Hoyerswerda
Germany	Clinic for Bone Marrow Transplantation and Hematology and Oncology	Idar-Oberstein
Germany	Internistische Gemeinschaftspraxis - Jena	Jena
Germany	Klinikum der Friedrich-Schiller Universitaet Jena	Jena
Germany	Onkologische Gemeinschaftspraxis - Kaiserslautern	Kaiserslautern
Germany	Westpfalz-Klinikum GmbH	Kaiserslautern
Germany	St. Vincentius - Kliniken	Karlsruhe
Germany	Staedtisches Klinikum Karlsruhe gGmbH	Karlsruhe
Germany	Internistische Gemeinschaftspraxis - Kassel	Kassel
Germany	Red Cross Hospital Kassel	Kassel
Germany	Klinikum Kempten Oberallgaeu	Kempten
Germany	Staedtisches Krankenhaus Kiel	Kiel
Germany	Praxis fuer Haematologie und Onkologie	Koblenz
Germany	Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH	Koblenz
Germany	Leonardis Clinic	Kornwestheim
Germany	Haematologische / Onkologische Schwerpunktpraxis	Krefeld
Germany	Klinikum Krefeld GmbH	Krefeld
Germany	Frankenwald Klinik	Kronach
Germany	Internistische Onkologische Praxis - Kronach	Kronach
Germany	Internistische Praxis - Landshut	Landshut
Germany	Klinikum Landshut	Landshut
Germany	Caritas - Krakenhaus Lebach	Lebach
Germany	Onkologische Schwerpunktpraxis - Leer	Leer
Germany	Forschungsgesellschaft mbH	Leipzig
Germany	Gemeinschaftspraxis fuer Dres. Aldaoud und Schwarzer	Leipzig
Germany	Klinikum "St. Georg" Leipzig	Leipzig
Germany	Praxis fuer Onkologie am Diakonissenhaus	Leipzig
Germany	University Leipzig Clinic of Internal Medicine	Leipzig
Germany	Klinikum Lippe - Lemgo	Lemgo
Germany	St. Vincenz Hospital Limburg	Limburg
Germany	St. Bonifatius Hospital Lingen	Lingen
Germany	Dreifaltigkeits Hospital	Lippstadt
Germany	Kreiskrankenhaus Loerrach	Loerrach
Germany	Onkologische Schwerpunktpraxis	Loerrach
Germany	Klinikum Ludwigsburg	Ludwigsburg
Germany	St. Marien Hospital Ludwighafen	Ludwigshafen
Germany	Klinikum der Stadt Ludwigshafen am Rhein	Ludwigshafen am Rhein
Germany	Sana Kliniken Luebeck	Luebeck
Germany	Schwerpunktpraxis fuer Haematologie und Onkologie - Luebeck	Luebeck
Germany	Universitaetsklinikum Schleswig-Holstein - Campus Luebeck	Luebeck
Germany	Kreiskrankenhaus Luedenscheid	Luedenscheid
Germany	Internistische Gemeinschaftspraxis - Magdeburg	Magdeburg
Germany	Staedtisches Klinikum Magdeburg - Altstadt	Magdeburg
Germany	Universitatsklinikum der MA	Magdeburg
Germany	Johannes Gutenberg University	Mainz
Germany	St. Vincenz und Elisabeth Hospital	Mainz
Germany	Gemeinschaftspraxis	Mannheim
Germany	III Medizinische Klinik Mannheim	Mannheim
Germany	Schwerpunktpraxis Internist Onkologie - Marburg	Marburg
Germany	Universitaetsklinikum Giessen und Marburg GmbH - Marburg	Marburg
Germany	Regional Hospital Mayen	Mayen
Germany	Gemeinschaftspraxis Dres. med. Ellbrueck/Goeller/Kraenzle/Niedermeier/Jocham	Memmingen
Germany	Krankenhaus Ludmillenstift	Meppen
Germany	Gemeinschaftspraxis - Minden	Minden
Germany	Klinikum Minden	Minden
Germany	Haematologische Praxis - Moenchengladbach	Moenchengladbach
Germany	Krankenhaus Maria Hilf GmbH	Moenchengladbach
Germany	Ev. Hospital Bethesda	Monchengladbach
Germany	Evangelisches Krankenhaus - Muelheim	Muelheim an der Ruhr
Germany	St. Marien Hospital - Muelheim an der Ruhr	Muelheim An Der Ruhr
Germany	Gemeinschaftspraxis - Muenster	Muenster
Germany	Haematologisch - Onkologische Gemeinschaftspraxis - Muenster	Muenster
Germany	Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster	Muenster
Germany	Kreiskrankenhaus Muenchberg	Münchberg
Germany	Klinikum der Universitaet Muenchen - Grosshadern Campus	Munich
Germany	Klinikum Rechts Der Isar - Technische Universitaet Muenchen	Munich
Germany	Krankenhaus Muenchen Schwabing	Munich
Germany	Munich Oncologic Practice at Elisenhof	Munich
Germany	Municipal Hospital Munich	Munich
Germany	Staedtisches Krankenhaus Muenchen - Harlaching	Munich
Germany	Universitaets - Kinderpoliklinik	Munich
Germany	Klinikum Schwaebisch Gmuend Stauferklinik	Mutlangen
Germany	Staedtisches Krankenhaus Nettetal GmbH	Nettetal
Germany	Klinikum Neubrandenburg	Neubrandenburg
Germany	Onkologische Schwerwpunktpraxis Dr. Ladda	Neumarkt
Germany	Regional Hospital Neumarkt	Neumarkt
Germany	Onkologische Schwerpunktpraxis Dr. Schmidt	Neunkirchen
Germany	Staedtisches Klinikum Neunkirchen gGmbH	Neunkirchen
Germany	Internistische Praxis - Neuss	Neuss
Germany	Lukaskrankenhaus Neuss	Neuss
Germany	DRK Krankenhaus Neuwied	Neuwied
Germany	Praxis fuer Haematologie und Interne Onkologie	Norderstedt
Germany	Gemeinschaftspraxis fuer Onkologie - Nordhorn	Nordhorn
Germany	Gemeinschaftspraxis fuer Haematologie - Northeim	Northeim
Germany	Klinikum Nuernberg - Klinikum Nord	Nuremberg
Germany	Praxisklinik fuer Innere Medizin - Nuernberg	Nuremberg
Germany	Schlossbergkliniken Oberstaufen	Oberstaufen
Germany	Internistische Gemeinschaftspraxis - Offenbach	Offenbach
Germany	Klinikum Offenburg	Offenburg
Germany	Ev. Hospital Oldenburg	Oldenburg
Germany	Internistische Gemeinschaftspraxis - Oldenburg	Oldenburg
Germany	Klinikum Oldenburg	Oldenburg
Germany	Pius Hospital - Oldenburg	Oldenburg
Germany	St. Martinus Hospital - Olpe	Olpe
Germany	Klinikum Osnabrück GmbH	Osnabrück
Germany	Marien Hospital	Osnabrück
Germany	Paracelsus - Klinik Osnabrück	Osnabrück
Germany	Bruederkrankenhaus St. Josef Paderborn	Paderborn
Germany	Asklepios Klinik - Parchim	Parchim
Germany	Krankenhaus Siloah - Pforzheim	Pforzheim
Germany	Praxis fuer Innere Medizin am Krankenhaus Siloah - Pforzheim	Pforzheim
Germany	Staedtisches Krankenhaus	Pforzheim
Germany	Gemeinschaftspraxis - Pinneberg	Pinneberg
Germany	Klinikum Ernst Von Bergmann	Potsdam
Germany	Kreiskrankenhaus Radebeul	Radebeul
Germany	Gemeinschaftspraxis - Ravensburg	Ravensburg
Germany	Krankenhaus St. Elisabeth - Ravensburg	Ravensburg
Germany	Elisabeth Krankenhaus	Recklinghausen
Germany	Prosper-Hospital Recklinghausen	Recklinghausen
Germany	Hematologische Onkologische Praxis	Regensburg
Germany	Klinikum der Universitaet Regensburg	Regensburg
Germany	Krankenhaus Barmherzige Brueder Regensburg	Regensburg
Germany	Internistische Praxis Dres. Hempel und Hochdorfer	Rehling
Germany	Klinikum Remscheid GmbH	Remscheid
Germany	Jakobi Krankenhaus	Rheine
Germany	Haematologische/Onkologische Schwerpunktpraxis - Rostock	Rostock
Germany	Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock	Rostock
Germany	Klinikum Suedstadt Rostock	Rostock
Germany	Diakonie - Krankenhaus	Rotenburg
Germany	Internistische Schwerpunktpraxis	Russelsheim
Germany	Caritasklinik St. Theresia	Saarbrucken
Germany	Gemeinschaftspraxis - Saarbruecken	Saarbruecken
Germany	St. Elizabeth-Klinik Saarlouis	Saarlouis
Germany	Martin - Luther Hospital	Schleswig
Germany	Praxis fur Innere Medizin - Schmiedeberg	Schmiedeberg
Germany	Deaconess Hospital	Schwabisch Hall
Germany	Gemeinschaftspraxis fuer Haematologie und Internist - Schweinfurt	Schweinfurt
Germany	Leopoldina - Krankenhaus	Schweinfurt
Germany	HELIOS Klinikum - Schwelm	Schwelm
Germany	Klinikum Schwerin	Schwerin
Germany	Evang. Jung-Stilling Hospital	Siegen
Germany	St. Marien - Krankenhaus Siegen GMBH	Siegen
Germany	St. Lukas - Clinic Solingen	Solingen
Germany	Krankenhaus Maria-Hilf - Stadtlohn	Stadtlohn
Germany	Onkologische Schwerpunktpraxis - Straubing	Straubing
Germany	Diakonie Klinikum Stuttgart	Stuttgart
Germany	Gastroenterologische und Haematologisch-Onkologische Praxis E. M. Dr. Hoering von Ehr Respondek	Stuttgart
Germany	Haematologische Praxis	Stuttgart
Germany	Hospital Bad Cannstatt	Stuttgart
Germany	Klinik fuer Onkologie - Katharinenhospital Stuttgart	Stuttgart
Germany	Klinikum Stuttgart - Buergerhospital	Stuttgart
Germany	Robert-Bosch-Krankenhaus	Stuttgart
Germany	St. Elisabeth Hospital Thuine	Thuine
Germany	Regional Hospital Traunstein	Traunstein
Germany	Krankenanstalt Mutterhaus der Borromaerinnen	Trier
Germany	Krankenhaus Der Barmherzigen Brueder	Trier
Germany	Onkologische Gemeinschaftspraxis - Trier	Trier
Germany	Praxis Fuer Internistische Haematologie / Onkologie	Troisdorf
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Germany	Hospital Tutzing	Tutzing
Germany	Praxis fuer Haematologie und Onkologie	Twistringen
Germany	Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm	Ulm
Germany	Ev. Hospital Unna	Unna
Germany	St. Marienhospital - Vechta	Vechta
Germany	Onkologische Schwerpunktpraxis - Villingen	Villingen
Germany	Municipal Hospital Complex	Villingen-Schwenningen
Germany	Regional Hospital Waldbrol	Waldbrol
Germany	Haematologische Praxis	Weiden
Germany	Gemeinschaftspraxis feur Haemotologie und Onkologie - Weilheim	Weilheim
Germany	Sophien - und Hufeland - Klinikum Weimar gGmbH	Weimar
Germany	Onkologische Schwerpunktpraxis	Wendlingen
Germany	Harz-Klinikum Wernigerode-Blankenburg GmbH	Wernigerode
Germany	Asklepios Nordseeklinik Westerland GmbH	Westerland
Germany	Ammerland-Klinik GmbH	Westerstede
Germany	Hospital Wetzler	Wetzlar
Germany	Deutsche Klinik fuer Diagnostik	Wiesbaden
Germany	Dr. Horst-Schmidt-Kliniken	Wiesbaden
Germany	Ev. Hospital Witten-Herdecke	Witten
Germany	Evangelisches Krankenhaus - Lutherstadt Wittenberg	Wittenberg
Germany	Klinikum der Stadt Wolfsburg	Wolfsburg
Germany	Burkhard and Reimann Gemeinschaftspraxis	Worms
Germany	Medizinische Poliklinik, Universitaet Wuerzburg	Wuerzburg
Germany	Helios Kliniken Wuppertal University Hospital	Wuppertal
Germany	Kliniken St. Antonius	Wuppertal 2
Germany	Heinrich-Braun-Krankenhaus Zwickau	Zwickau
Italy	Azienda Ospedaliera di Padova	Padova
Netherlands	Erasmus MC - Sophia Children's Hospital	Rotterdam
Poland	Akademia Medyczna im. Piastow Slaskich	Wroclaw
Sweden	Goeteborg University	Goeteborg
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	Universitaets-Kinderspital beider Basel	Basel
Switzerland	Ospedale "la Carita", Locarno	Locarno
Switzerland	Kinderspital Luzern	Lucerne 16
Switzerland	Ostschweizer Kinderspital	St. Gallen
Switzerland	University Children's Hospital	Zurich
United Kingdom	Royal Manchester Children's Hospital	Manchester	England

Sponsors (1)

Lead Sponsor	Collaborator
German High-Grade Non-Hodgkin's Lymphoma Study Group

Countries where clinical trial is conducted

Czechia,  France,  Germany,  Italy,  Netherlands,  Poland,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		-4 to 491 days of treatment
Primary	Safety and treatment related deaths at 3 months after study completion		3 months after study completion
Primary	Toxicity assessed by NCI criteria, adverse events, serious adverse events, protocol adherence, and treatment-related deaths at 3 months after study completion		3 months after study completion
Secondary	Time to treatment failure assessed at 2 years within the study and periodically thereafter		at 2 years within the study and periodically thereafterlif
Secondary	Complete response rate assessed at 2 years within the study and periodically thereafter		at 2 years within the study and periodically thereafter
Secondary	Progression rate		life-long
Secondary	Survival time		life-long
Secondary	Progression-free survival		life-long