Rituximab and Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma
Conditions
Lymphoma
Conditions: official terms
Lymphoma
Conditions: Keywords
contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, stage I grade 3 follicular lymphoma, contiguous stage II adult diffuse large cell lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult diffuse mixed cell lymphoma, nodal marginal zone B-cell lymphoma, anaplastic large cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, stage I adult immunoblastic large cell lymphoma, contiguous stage II adult Burkitt lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II adult Burkitt lymphoma, noncontiguous stage II mantle cell lymphoma, stage I adult Burkitt lymphoma, stage I mantle cell lymphoma, contiguous stage II marginal zone lymphoma, noncontiguous stage II marginal zone lymphoma, stage I marginal zone lymphoma, stage III marginal zone lymphoma, stage IV marginal zone lymphoma, stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage IV adult Burkitt lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: rituximab Type: Biological
Name: cyclophosphamide Type: Drug
Name: doxorubicin hydrochloride Type: Drug
Name: prednisone Type: Drug
Name: vincristine sulfate Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 60 Years
Minimum Age: 18 Years
Gender: Both
Criteria: DISEASE CHARACTERISTICS:

- Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma, including the following subtypes:

- Grade 3 follicular lymphoma

- Diffuse B-cell lymphoma, including diffuse large cell lymphoma with any of the following variants:

- Centroblastic

- Immunoblastic

- Plasmablastic

- Anaplastic large cell

- T-cell-rich B-cell lymphoma

- Primary effusion lymphoma

- Intravascular B-cell lymphoma

- Primary mediastinal B-cell lymphoma

- Burkitt's or Burkitt-like lymphoma

- Mantle cell lymphoma (blastoid)

- Aggressive marginal zone lymphoma (monocytoid)

- Previously untreated disease

- CD20-positive disease

- International Prognostic Index (IPI) score 0

- No bulky disease

- Largest single or conglomerate tumor < 7.5 cm in diameter

- No mucosa-associated lymphoid tissue (MALT) lymphoma

- No CNS involvement of lymphoma (intracerebral, meningeal, or intraspinal)

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Platelet count ≥ 100,000/mm^3

- WBC ≥ 2,500/mm^3

- Lactate dehydrogenase normal

- Not pregnant or lactating

- Fertile patients must use effective contraception during and for 1 year after study participation

- Negative pregnancy test

- No known hypersensitivity to the study medications

- No known HIV-positivity

- No active hepatitis infection

- No impaired left ventricular function

- No severe cardiac arrhythmias

- No other impaired organ function

- No other serious disorder

- No other malignancy within the past 5 years except carcinoma in situ or basal cell skin cancer

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy or radiotherapy

- No prior immunosuppressive treatment with cytostatics

- No planned radiotherapy to extranodal involvement

- No concurrent participation in other treatment studies
Locations
Haematologisch Onkologische Praxis
Aachen, Germany
Status: Recruiting
Contact: D. Tummes, MD - 49-241-990-0550 - tummes@onkologie-aachen.de
Klinikum Augsburg
Augsburg, Germany
Status: Recruiting
Contact: Gunter Schlimok, MD - 49-821-400-2353 - schlimok@klinikum-augsburg.de
Klinikum Bayreuth
Bayreuth, Germany
Status: Recruiting
Contact: Contact Person - 49-921-400-00
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, Germany
Status: Recruiting
Contact: Eckhard Thiel, MD - 49-30-8445-2337 - haema.cbf@charite.de
Haematologisch-Onkologische Schwerpunktpraxis - Weilheim
Berlin, Germany
Status: Recruiting
Contact: Ilona Blau, MD - 49-30-461-4857
Franziskus Hospital
Bielefeld, Germany
Status: Recruiting
Contact: H.J. Weh, MD - 49-521-5897-1200
Augusta-Kranken-Anstalt gGmbH
Bochum, Germany
Status: Recruiting
Contact: D. Behringer, MD - 49-234-517-2430 - behringer@augusta-bochum.de
Staedtisches Klinikum Braunschweig
Braunschweig, Germany
Status: Recruiting
Contact: Contact Person - 49-531-595-3224
DIAKO Ev. Diakonie Krankenhaus gGmbH
Bremen, Germany
Status: Recruiting
Contact: Karl-Heinz Pflueger, MD - 49-421-6102-1481 - pfluegerkh@diako-bremen.de
Hospital Kuchwald Chemnitz
Chemnitz, Germany
Status: Recruiting
Contact: Contact Person - 49-371-333-42700
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, Germany
Status: Recruiting
Contact: Michael Hallek, MD - 49-221-478-4400
Praxis Fuer Haematologie Internistische Onkologie
Cologne, Germany
Status: Recruiting
Contact: C. Gabor, MD - 49-221-931-8220
Carl - Thiem - Klinkum Cottbus
Cottbus, Germany
Status: Recruiting
Contact: H. B. Steinhauer, MD - 49-355-462-223
Praxis Dr. Rheinhold Siegmund - Dr. Matthias Penke
Damme, Germany
Status: Recruiting
Contact: Rheinhold Siegmund, MD - 49-554-91-90-90-80
Klinikum Dortmund
Dortmund, Germany
Status: Recruiting
Contact: Michael Heike, MD - 49-231-9532-1770 - michael.heike@klinikumdo.de
Hans - Susemihl - Krankenhaus
Emden, Germany
Status: Recruiting
Contact: H. Becker, MD - 49-4921-981-295 - h.becker@hsk-emden.de
St. Antonius Hospital
Eschweiler, Germany
Status: Recruiting
Contact: Roland Fuchs, MD - 49-240-376-1280 - info@onkologie-eschweiler.de
Universitaetsklinikum Essen
Essen, Germany
Status: Recruiting
Contact: Ulrich Duehrsen, MD - 49-41-945-000 - ulrich.duehrsen@uk-essen.de
Klinikum Frankfurt (Oder) GmbH
Frankfurt (Oder), Germany
Status: Recruiting
Contact: Michael G. Kiehl, MD, PhD - 49-335-548-4601 - m.kiehl.km@klinikumffo.de
Universitaetsklinikum Freiburg
Freiburg, Germany
Status: Recruiting
Contact: Roland H. Mertelsmann, MD, PhD - 49-761-270-7367 - mertelsmann@mmll.ukl.uni-freiburg.de
Klinikum Fulda
Fulda, Germany
Status: Recruiting
Contact: Heinz-Gert Hoeffkes, MD - 49-661-84-54-81 - hoeffkes.tumorklinik@klinikum-fulda.de
Saint Josef Hospital
Gelsenkirchen, Germany
Status: Recruiting
Contact: Contact Person - 49-209-504-5300
Universitaetsklinikum Goettingen
Goettingen, Germany
Status: Recruiting
Contact: L. Trumper - 49-551-396-810
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, Germany
Status: Recruiting
Contact: Gottfried Doelken, MD - 49-3834-866-698 - doelken@uni-greifswald.de
Kreiskrankenhaus Gummersbach GMBH
Gummersbach, Germany
Status: Recruiting
Contact: Sieber, MD - 49-2261-171-350
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
Hagen, Germany
Status: Recruiting
Contact: Hartmut Eimermacher, MD - 49-2331-129-250
St. Sixtus Hospital
Haltern, Germany
Status: Recruiting
Contact: A. Bracht, MD - 49-2364-1040
Asklepios Klinik St. Georg
Hamburg, Germany
Status: Recruiting
Contact: Contact Person - 49-40-1818-8511
Haematologisch-Onkologische Praxis Altona
Hamburg, Germany
Status: Recruiting
Contact: Wiebke Hollburg, MD - 49-40-3802-1280
University Medical Center Hamburg - Eppendorf
Hamburg, Germany
Status: Recruiting
Contact: Carsten Bokemeyer, MD - 49-40-428-030 - c.bokemeyer@uke.uni-hamburg.de
Evangelische Krankenhaus Hamm
Hamm, Germany
Status: Recruiting
Contact: Leopold Balleisen, MD - 49-2381-589-1275 - LBalleisen@evkhamm.de
St. Marien-Hospital Hamm - Klinik Knappenstrasse
Hamm, Germany
Status: Recruiting
Contact: Heinz A. Duerk, MD, PhD - 49-2381-18-22-51 - heinz.duerk@marienhospital-hamm.de
Medizinische Hochschule Hannover
Hannover, Germany
Status: Recruiting
Contact: Arnold Ganser, PhD, MD - 49-511-532-3020 - ganser.arnold@mh-hannover.de
Ruprecht - Karls - Universitaet Heidelberg
Heidelberg, Germany
Status: Recruiting
Contact: Anthony D. Ho, MD, PhD - 49-6221-56-8001 - anthony_ho@med.uni-heidelberg.de
St. Bernward Krankenhaus
Hildesheim, Germany
Status: Recruiting
Contact: Ulrich Kaiser, MD - 49-5-121-90-12-73 - u.kaiser@bernward-khs.de
Universitaetsklinikum des Saarlandes
Homburg, Germany
Status: Recruiting
Contact: Michael G.M. Pfreundschuh, MD - 49-6841-162-3084 - michael.pfreundschuh@uniklinik-saarland.de
Clinic for Bone Marrow Transplantation and Hematology and Oncology
Idar-Oberstein, Germany
Status: Recruiting
Contact: Axel A. Fauser, MD, PhD - 49-6781-66-1590
St. Vincentius - Kliniken
Karlsruhe, Germany
Status: Recruiting
Contact: J. Mezger, MD - 49-721-8108-3014
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, Germany
Status: Recruiting
Contact: Martin Bentz - 49-721-974-3001
Klinikum Kempten Oberallgaeu
Kempten, Germany
Status: Recruiting
Contact: Otto Pruemmer, MD - 49-549-19-09-08-0 - otto.pruemmer@klinikum-kempten.de
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, Germany
Status: Recruiting
Contact: Michael Kneba - 49-431-1697-1201
Caritas - Krakenhaus Lebach
Lebach, Germany
Status: Recruiting
Contact: Stephan Kremers, MD - 49-68-881-5010
Klinikum Lippe - Lemgo
Lemgo, Germany
Status: Recruiting
Contact: Frank Hartmann, MD - 49-5261-264-123 - frank.hartmann@klinikum-lippe.de
St. Vincenz Hospital Limburg
Limburg, Germany
Status: Recruiting
Contact: K. P. Schalk, MD - 49-6431-292-4330
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen am Rhein, Germany
Status: Recruiting
Contact: Martin Hoffmann, MD - 49-621-503-3942 - hoffmanm@klilu.de
Kreiskrankenhaus Luedenscheid
Luedenscheid, Germany
Status: Recruiting
Contact: Gerhard Heil, MD - 49-235-1460
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, Germany
Status: Recruiting
Contact: Martin Mohren, MD - 49-391-671-3266 - martin.mohren@medizin.uni-magdeburg.de
III Medizinische Klinik Mannheim
Mannheim, Germany
Status: Recruiting
Contact: Ruediger Hehlmann, MD - 49-621-383-4115 - Ruediger.Hehlmann@med3.ma.uni-heidelberg.de
Universitaetsklinikum Giessen und Marburg GmbH - Marburg
Marburg, Germany
Status: Recruiting
Contact: Andreas Neubauer, MD - 49-6421-28-66-273 - neubauer@mailer.uni-marburg.de
Krankenhaus Ludmillenstift
Meppen, Germany
Status: Recruiting
Contact: Ulrich Ohl, MD - 49-5931-152-1400
Krankenhaus Maria Hilf GmbH
Moenchengladbach, Germany
Status: Recruiting
Contact: Ullrich Graeven, MD, PhD - 49-2161-892-2212 - inneren@mariahilf.de
Haematologisch - Onkologische Gemeinschaftspraxis - Muenster
Muenster, Germany
Status: Recruiting
Contact: Christian Lerchenmueller, MD - 49-251-620-080
Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
Muenster, Germany
Status: Recruiting
Contact: Contact Person - 49-251-837-586
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, Germany
Status: Recruiting
Contact: Wolfgang Hiddemann, MD, PhD - 49-89-7095-2551
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, Germany
Status: Recruiting
Contact: Ulrich Keller, MD - 49-89-4140-7435 - ulrich.keller@lrz.tum.de
Klinikum Schwaebisch Gmuend Stauferklinik
Mutlangen, Germany
Status: Recruiting
Contact: Holger Hebart, MD - 49-7171-701-1302 - holger.hebart@klinikum-sgd.de
Onkologische Schwerwpunktpraxis Dr. Ladda
Neumarkt, Germany
Status: Recruiting
Contact: Ekkehart Ladda, MD - 49-91-8146-4526 - ekkehart.ladda@gmx.de
Lukaskrankenhaus Neuss
Neuss, Germany
Status: Recruiting
Contact: Contact Person - 49-2131-888-2701
Schlossbergkliniken Oberstaufen
Oberstaufen, Germany
Status: Recruiting
Contact: Contact Person - 49-8386-7010
Klinikum Oldenburg
Oldenburg, Germany
Status: Recruiting
Contact: Claus-Henning Koehne, MD - 49-441-403-2648 - onkologie@klinikum-oldenburg.de
Pforzheim, Germany
Status: Recruiting
Contact: Yves Dencausse, MD - 49-7231-280-3780
Klinikum Ernst Von Bergmann
Potsdam, Germany
Status: Recruiting
Contact: Georg Maschmeyer, MD - 49-331-241-6002 - gmaschmeyer@klinikumevb.de
Prosper-Hospital Recklinghausen
Recklinghausen, Germany
Status: Recruiting
Contact: Thomas Hoehler, MD - 49-2361-54-26-51
Rostock, Germany
Status: Recruiting
Contact: Volker Lakner, MD - 49-381-493-4276
St. Marien - Krankenhaus Siegen GMBH
Siegen, Germany
Status: Recruiting
Contact: Winfried Gassmann, MD - 49-271-231-1310
Diakonie Klinikum Stuttgart
Stuttgart, Germany
Status: Recruiting
Contact: Contact Person - 49-711-991-3500
Krankenanstalt Mutterhaus der Borromaerinnen
Trier, Germany
Status: Recruiting
Contact: Michael Clemens, MD - 49-651-947-2376 - clemens@uni-trier.de
Southwest German Cancer Center at Eberhard-Karls-University
Tuebingen, Germany
Status: Recruiting
Contact: Lothar Kanz, MD - 49-7071-298-2726 - lothar.kanz@med.uni-tuebingen.de
Universitaetsklinikum Tuebingen
Tuebingen, Germany
Status: Recruiting
Contact: Contact Person - 49-7071-298-2087
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, Germany
Status: Recruiting
Contact: Hartmut Doehner, MD - 49-731-3002-4401 - hartmut.doehner@uniklinik-ulm.de
St. Marienhospital - Vechta
Vechta, Germany
Status: Recruiting
Contact: J. Diers, MD - 49-4441-99-1201
Onkologische Schwerpunktpraxis
Wendlingen, Germany
Status: Recruiting
Contact: Robert Eckert, MD - 49-70-242-331
Dr. Horst-Schmidt-Kliniken
Wiesbaden, Germany
Status: Recruiting
Contact: Norbert Frickhofen, MD - 49-611-433-018 - norbert.frickhofen@hsk-wiesbaden.de
Helios Kliniken Wuppertal University Hospital
Wuppertal, Germany
Status: Recruiting
Contact: Contact Person - 49-202-896-2820
Rabin Medical Center - Beilinson Campus
Petah-Tikva, Israel
Status: Recruiting
Contact: Contact Person - 972-3-937-7377
Ospedale Civile - Piacenza
Piacenza, Italy
Status: Recruiting
Contact: Contact Person - 39-523-490-872
Arcispedale S. Maria Nuova
Reggio Emilia, Italy
Status: Recruiting
Contact: Contact Person - 39-0522-296-623
Cellulari ed Ematologia Sapienza
Roma, Italy
Status: Recruiting
Contact: Contact Person - 49-6-857-951
Start Date
November 2005
Sponsors
German High-Grade Non-Hodgkin's Lymphoma Study Group
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page