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Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00052936
Recruitment Status : Unknown
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : March 12, 2010
Information provided by:
National Cancer Institute (NCI)

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).

Condition or disease Intervention/treatment Phase
Lymphoma Biological: filgrastim Biological: rituximab Drug: CHOP regimen Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Radiation: radiation therapy Phase 3

Detailed Description:



  • Compare the efficacy of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with vs without rituximab in elderly patients with aggressive non-Hodgkin's lymphoma.
  • Compare the efficacy of 6 vs 8 courses of CHOP chemotherapy in patients treated with these regimens.
  • Compare the rate of complete remission, rate of primary progression, tumor control, disease-free survival, overall survival, and relapse after radiotherapy in patients treated with these regimens.
  • Compare the safety and side effects of these regimens in these patients.


  • Compare short-term and long-term side effects of these regimens in these patients.
  • Compare quality of life of patients treated with these regimens.
  • Compare the cost of these regimens in these patients.
  • Determine relapse in patients treated with these regimens who received involved-field radiotherapy.

OUTLINE: This is a randomized (randomized part of study completed as of 6/2005), open-label, multicenter study. Patients are stratified according to participating center, value for serum lactic dehydrogenase (no greater than upper limit of normal [ULN] vs greater than ULN), bulky disease present (no vs yes), stage (I or II vs III or IV), general ECOG status of patient (0 or 1 vs 2), and age (61 to 70 vs 71-80). Patients are randomized to 1 of 4 treatment arms. Patients with CD20-negative lymphoma are randomized to arms I or II only.

  • Prephase treatment:Patients receive vincristine IV on day -6 and prednisone on day -6 to day 0 before initiating CHOP chemotherapy.
  • Arm I (closed to accrual as of 7/25/2005): Patients receive standard CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 6-12 of each CHOP course. Treatment repeats every 2 weeks for 6 courses.
  • Arm II (closed to accrual as of 7/25/2005): Patients receive standard CHOP chemotherapy and G-CSF as in arm I for a total of 8 courses.
  • Arm III: Patients receive standard CHOP chemotherapy and G-CSF as in arm I. Patients also receive rituximab IV before CHOP every 2 weeks for a total of 8 courses.
  • Arm IV (closed to accrual as of 7/25/2005): Patients receive standard CHOP chemotherapy and G-CSF as in arm II. Patients also receive rituximab IV before CHOP every 2 weeks for a total of 8 courses.

In all arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Beginning 3-6 weeks after completion of the last chemotherapy course, after complete recovery of bone marrow, and after complete remision of mucositis, patients with sites of initial bulky disease or extranodal involvement undergo radiotherapy 5 times a week for 4 weeks.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 1580 patients will be accrued for this study within 5 years.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1580 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2001

Primary Outcome Measures :
  1. Time to treatment failure at 3 years within the study and then periodically after study completion

Secondary Outcome Measures :
  1. Complete response rate at 3 years within the study and then periodically after study completion
  2. Progression rate
  3. Survival
  4. Tumor control
  5. Disease-free survival

Information from the National Library of Medicine

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Ages Eligible for Study:   61 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) by an excisional biopsy of a lymph node or an extensive biopsy of an extranodal involvement (if there is no lymph node involvement)
  • CD20^+ B-cell lymphoma or CD20^- B-cell and T-cell lymphoma allowed
  • B-cell NHL including the following:

    • Stage III follicular lymphoma
    • Stage III follicular lymphoma and diffuse B-cell lymphoma
    • Lymphoblastic precursor B-cell lymphoma
    • Diffuse large cell B-cell lymphoma

      • Centroblastic
      • Immunoblastic
      • Plasmablastic
      • Anaplastic large cell
      • T-cell-rich B-cell lymphoma
      • Primary effusion lymphoma
      • Intravasal B-cell lymphoma
      • Primary mediastinal B-cell lymphoma
    • Mantle zone lymphoma, blastoid
    • Burkitt's lymphoma
    • Burkitt-like lymphoma
    • Aggressive marginal zone lymphoma (monocytoid)
  • T-cell NHL including the following:

    • Lymphoblastic precursor T-cell lymphoma
    • Peripheral T-cell lymphoma (PTCL) not otherwise specified (NOS)

      • Lennert's lymphoma
      • T-zone lymphoma
    • T-cell lymphoma of the angioimmunoblastic lymphadenopathy with dysproteinemia (AILD) type
    • Anaplastic large cell lymphoma

      • ALK^+
      • ALK^-
    • Extranodal NK/T-cell lymphoma, nasal type
    • Intestinal T/NK-cell lymphoma (with or without enteropathy)

      • Hepatosplenic gamma-delta lymphoma
      • Subcutaneous panniculitis-like PTCL
      • Aggressive T/NK PTCL
    • Anaplastic large-cell NHL, NOS
  • Bone marrow involvement no more than 25%
  • No lymphoma that is clearly restricted to the CNS or originating from the gastrointestinal tract



  • 61 to 80

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • Not specified


  • WBC at least 2,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • No active hepatitis infection


  • Creatinine no greater than 2 times ULN


  • No Canadian Cardiovascular Society class III or IV angina pectoris
  • No New York Heart Association class III or IV cardiac failure
  • Ejection fraction at least 50%
  • Fractional shortenings at least 25% by echocardiography or nuclear medicine examination


  • FEV1 at least 50%
  • Diffusion capacity at least 50%


  • No uncontrolled diabetes mellitus
  • No known hypersensitivity to any study medications
  • No other concurrent malignancy
  • HIV negative


Biologic therapy

  • Not specified


  • No prior chemotherapy

Endocrine therapy

  • Not specified


  • No prior radiotherapy


  • Not specified


  • Must not have already initiated lymphoma therapy (except for the prephase treatment specified for this study)
  • No other concurrent lymphoma therapy
  • No concurrent participation in another treatment study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00052936

  Hide Study Locations
Haematologisch Onkologische Praxis
Aachen, Germany, 52070
Klinikum St. Marien
Amberg, Germany, D-92224
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
Ansbach, Germany, 91522
II. Medizinische Klinik
Aschaffenburg, Germany, 63739
Specialist Practice for Oncology
Aschaffenburg, Germany, 63739
Haematologische Praxis
Augsburg, Germany, 86150
Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg
Augsburg, Germany, 86150
Klinikum Augsburg
Augsburg, Germany, D-86156
Kreiskrankenhaus Aurich
Aurich, Germany, D-26603
Regional Hospital Am Plattenwald
Bad Friedrichshall, Germany, 74172
Regional Hospital Bad Hersfeld
Bad Hersfeld, Germany, 36251
Humaine - Clinic
Bad Saarow, Germany, 15523
Krankenhaus Hohe Warte Mediziniche Klinik
Bayreuth, Germany, D-95445
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
Berlin, Germany, 13125
Haematologisch-Onkologische Schwerpunktpraxis
Berlin, Germany, 13357
Hospital Complex Bernburg
Bernburg, Germany, 06406
Krankenhaus Bietigheim
Bietigheim, Germany, D-74321
Saint Agnes Hospital
Bocholt, Germany, 46397
Saint Josef Hospital
Bochum, Germany, 44791
Knappschaft Krankenhaus
Bochum, Germany, D-44892
Medizinische Poliklinik
Bonn, Germany, D-53111
Rheinische Friedrich-Wilhelms-Universitat
Bonn, Germany, D-53113
DIAKO Ev. Diakonie Krankenhaus gGmbH
Bremen, Germany, 28239
Medizinische Klinik Am Lukas - Krankenhaus
Bunde, Germany, D-32257
General Hospital
Celle, Germany, 29223
Hospital Kuchwald Chemnitz
Chemnitz, Germany, 09113
Cologne-Kalk, Germany, D-51105
Lung Clinic Cologne-Merheim
Cologne-Merheim, Germany, D-51109
Praxis Fuer Haematologie Internistische Onkologie
Cologne, Germany, D-50677
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, Germany, D-50924
Carl - Thiem - Klinkum Cottbus
Cottbus, Germany, 03048
Klinikum Darmstadt
Darmstadt, Germany, D-64283
Saint Johannes Hospital Dortmund
Dortmund, Germany, 44137
Universitatsklinikum Carl Gustav Carus
Dresden, Germany, D-01307
St. Johannes Hospital - Medical Klinik II
Duisburg, Germany, 47166
Franz Hospital Dulmen
Dulmen, Germany, 48249
Florence-Nightingale-Krankenhause, Deaconess Kaiserswerth
Dusseldorf, Germany, 40489
Hans - Susemihl - Krankenhaus
Emden, Germany, 26721
Klinikum Erfurt
Erfurt, Germany, D-99089
St. Antonius Hospital
Eschweiler, Germany, 52249
Evangelisches Krankenhaus Essen Werden
Essen-Werden, Germany, 45239
Universitaetsklinikum Essen
Essen, Germany, 45147
Klinikum Frankfurt (Oder) GmbH
Frankfurt/Oder, Germany, D-15236
Krankenhaus Nordwest
Frankfurt, Germany, D-60488
Evang. Deaconess Hospital Freiburg
Freiburg, Germany, 79110
Municipal Hospital Complex
Fulda, Germany, D-36043
Robert - Koch Hospital
Gehrden, Germany, 30989
Centre for Internal Medicine Gieben
Gieben, Germany, 35392
Universitaetsklinikum Goettingen
Goettingen, Germany, 37075
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, Germany, 17489
Staedtisches Klinikum Guetersloh
Gutersloh, Germany, 33332
Allgemeines Krankenhaus Hagen
Hagen, Germany, 58095
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
Hagen, Germany, 58095
Krankenhaus St. Elisabeth und St. Barbara
Halle/Saale, Germany, 06110
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle, Germany, 06120
Universitaetsklinikum Halle
Halle, Germany, D-06120
Hamburg, Germany, 20095
University Medical Center Hamburg - Eppendorf
Hamburg, Germany, 20251
Asklepios Klinik Nord Heidberg
Hamburg, Germany, 22413
Allgemeines Krankenhaus Altona
Hamburg, Germany, 22763
Haematologisch-Onkologische Praxis Altona
Hamburg, Germany, D-22767
Evangelische Krankenhaus Hamm
Hamm, Germany, 59063
Hannover, Germany, 30159
Henriettenstiftung Krankenhaus
Hannover, Germany, 30559
Krankenhaus Siloah - Medizinische Klinik II
Hannover, Germany, D-30449
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Oncology Specialists Clinic
Harrislee, Germany, D-24955
Thoraxklinik Heidelberg
Heidelberg, Germany, 69126
Medizinische Universitaetsklinik und Poliklinik
Heidelberg, Germany, D-69115
Regional Hospital Heidenheim
Heidenheim, Germany, 89522
Klinikum Herford
Herford, Germany, D-32049
Marienhospital at Ruhr University Bochum
Herne, Germany, D-44625
Privatklinik Dr. R. Schindlbeck GmbH & Co. KG
Herrsching, Germany, D-82211
Onkologische Schwerpunktpraxis
Hildesheim, Germany, D-31134
Evang. Hospital
Holzminden, Germany, 37603
Medical University Hospital Homburg
Homburg, Germany, D-66421
Hospital Complex Hoyerswerda
Hoyerswerda, Germany, 02977
Gemeinschaftspraxis Innere Medizin
Jena, Germany, D-07743
Klinikum der Friedrich-Schiller Universitaet Jena
Jena, Germany, D-07747
Municipal Hospital Complex of the University
Kaiserslautern, Germany, D-67655
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, Germany, 76133
Red Cross Hospital Kassel
Kassel, Germany, 34121
Staedtisches Krankenhaus Kiel
Kiel, Germany, 23116
Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH
Koblenz, Germany, 56068
Praxis fuer Haematologie und Onkologie
Koblenz, Germany, D-56068
Leonardis Clinic
Kornwestheim, Germany, D-70806
Klinikum Krefeld GmbH
Krefeld, Germany, D-47805
Frankenwald Klinik
Kronach, Germany, 96317
Caritas - Krakenhaus Lebach
Lebach, Germany, 66822
University Leipzig Clinic of Internal Medicine
Leipzig, Germany, 04103
Klinikum "St. Georg" Leipzig
Leipzig, Germany, 04129
Leipzig, Germany, D-04103
Klinikum Lippe - Lemgo
Lemgo, Germany, D-32657
St. Vincenz Hospital Limburg
Limburg, Germany, 65549
St. Bonifatius Hospital Lingen
Lingen, Germany, 49808
Dreifaltigkeits Hospital
Lippstadt, Germany, 59555
Klinikum Ludwigsburg
Ludwigsburg, Germany, D-71640
St. Marien Hospital Ludwighafen
Ludwigshafen, Germany, 67067
Municipal Complex of Ludwigshafen
Ludwigshafen, Germany, D-67063
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Luebeck, Germany, D-23538
Staedtisches Klinikum Magdeburg - Altstadt
Magdeburg, Germany, 39104
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, Germany, 39120
Johannes Gutenberg University
Mainz, Germany, 55131
III Medizinische Klinik Mannheim
Mannheim, Germany, D-68305
Marburg, Germany, D-35037
Universitaetsklinikum Giessen und Marburg GmbH - Marburg
Marburg, Germany, D-35043
Regional Hospital Mayen
Mayen, Germany, 56727
Klinikum Minden
Minden, Germany, D-32423
Minden, Germany, D-32427
Ev. Hospital Bethesda
Monchengladbach, Germany, 41061
Hospital Maria-Hilf II
Monchengladbach, Germany, 41063
Monchenglasbach/Rheydt, Germany, D-41239
Evangelisches Krankenhaus - Mulheim
Mulheim/Ruhr, Germany, 45466
St. Marien Hospital - Muelheim an der Ruhr
Mulheim/Ruhr, Germany, 45468
Kreiskrankenhaus Muenchberg
Munchberg, Germany, 95213
Munich Oncologic Practice at Elisenhof
Munich, Germany, D-80335
Klinikum der Universitaet Muenchen - Innenstadt Campus
Munich, Germany, D-80336
Krankenhaus Muenchen Schwabing
Munich, Germany, D-80804
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, Germany, D-81377
Municipal Hospital Munich
Munich, Germany, D-81737
Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
Munster, Germany, D-48129
Regional Hospital Neumarkt
Neumarkt, Germany, 92318
Staedtisches Klinikum Neunkirchen gGmbH
Neunkirchen, Germany, 66538
Lukaskrankenhaus Neuss
Neus, Germany, D-41464
Klinikum Nuernberg - Klinikum Nord
Nuremberg, Germany, D-90340
Klinikum Offenburg
Offenburg, Germany, D-77654
Hematologische Praxis
Oldenburg, Germany, 26121
Ev. Hospital Oldenburg
Oldenburg, Germany, 26122
Klinikum Oldenburg
Oldenburg, Germany, D-26133
Paracelsus - Klinik Osnabrueck
Osnabrueck, Germany, D-49076
Municipal Hospital Complex
Pforzheim, Germany, D-75175
Klinikum Ernst Von Bergmann
Potsdam, Germany, D-14467
Kreiskrankenhaus Radebeul
Radebeul, Germany, D-01445
Krankenhaus St. Elisabeth - Ravensburg
Ravensburg, Germany, 88212
Klinikum der Universitaet Regensburg
Regensburg, Germany, 93042
Hematologische Onkologische Praxis
Regensburg, Germany, 93047
Krankenhaus Barmherzige Brueder Regensburg
Regensburg, Germany, D-93049
Jakobi Krankenhaus
Rheine, Germany, 48431
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
Rostock, Germany, 18057
Klinik und Poliklinik fuer Strahlentherapie - Universitaetsklinikum Rostock
Rostock, Germany, 18059
Rostock, Germany, D-18257
Caritasklinik St. Theresia
Saarbrucken, Germany, 66113
Schwerpunktpraxis fuer Haematologie und Onkologie
Saarbruecken, Germany, D-66113
St. Elizabeth-Klinik Saarlouis
Saarlouis, Germany, 66713
Martin - Luther Hospital
Schleswig, Germany, D-24837
Deaconess Hospital
Schwabisch Hall, Germany, 74523
Leopoldina - Krankenhaus
Schweinfurt, Germany, D-97422
Evang. Jung-Stilling Hospital
Siegen, Germany, 57074
St. Lukas - Clinic Solingen
Solingen, Germany, 42697
Klinik fuer Onkologie - Katharinenhospital Stuttgart
Stuttgart, Germany, 70174
Diakonie Klinikum Stuttgart
Stuttgart, Germany, 70176
Klinikum Stuttgart - Buergerhospital
Stuttgart, Germany, 70191
Hospital Bad Cannstatt
Stuttgart, Germany, 70374
Stuttgart, Germany, 70376
St. Elisabeth Hospital Thuine
Thuine, Germany, 49832
Regional Hospital Traunstein
Traunstein, Germany, 83278
Krankenanstalt Mutterhaus der Borromaerinnen
Trier, Germany, D-54290
Trier, Germany, D-54290
Krankenhaus Barmherzigen Brueder
Trier, Germany, D-54292
Hospital Tutzing
Tutzing, Germany, 82327
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, Germany, 89081
Ev. Hospital Unna
Unna, Germany, 59403
St. Marienhospital - Vechta
Vechta, Germany, 49377
Municipal Hospital Complex
Villingen-Schwenningen, Germany, D-78045
Regional Hospital Waldbrol
Waldbrol, Germany, 51545
Hospital Wetzler
Wetzlar, Germany, 35578
Deutsche Klinik fuer Diagnostik
Wiesbaden, Germany, 65191
Dr. Horst-Schmidt-Kliniken
Wiesbaden, Germany, 65199
Ev. Hospital Witten-Herdecke
Witten, Germany, 58455
Kliniken St. Antonius
Wuppertal, Germany, 42283
University Wurzburg
Wurzburg, Germany, 97070
Municipal Hospital Complex Zwickau
Zwickau, Germany, D-08060
City Hospital Triemli
Zurich, Switzerland, 8063
UniversitaetsSpital Zuerich
Zurich, Switzerland, 8091
Sponsors and Collaborators
German High-Grade Non-Hodgkin's Lymphoma Study Group
Study Chair: Michael G.M. Pfreundschuh, MD Universitaetsklinikum des Saarlandes

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00052936     History of Changes
Other Study ID Numbers: CDR0000269015
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 12, 2010
Last Verified: June 2007

Keywords provided by National Cancer Institute (NCI):
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
stage III grade 1 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III grade 2 follicular lymphoma
stage I adult T-cell leukemia/lymphoma
stage II adult T-cell leukemia/lymphoma
stage III adult T-cell leukemia/lymphoma
stage IV adult T-cell leukemia/lymphoma
contiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
stage I adult lymphoblastic lymphoma
stage III adult lymphoblastic lymphoma
stage IV adult lymphoblastic lymphoma
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 mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
stage I mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle 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 marginal zone lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents