Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	61 to 80	Other	DSHNHL-1999-1A EU-20243, NCT00052936

Objectives

Primary

1. Compare the efficacy of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with vs without rituximab in elderly patients with aggressive non-Hodgkin's lymphoma.
2. Compare the efficacy of 6 vs 8 courses of CHOP chemotherapy in patients treated with these regimens.
3. 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.
4. Compare the safety and side effects of these regimens in these patients.

Secondary

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

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy

Surgery

• Not specified

Other

• 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

Patient Characteristics:

Age

• 61 to 80

Performance status

• ECOG 0-2

  OR

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 2,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

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

Renal

• Creatinine no greater than 2 times ULN

Cardiovascular

• 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

Pulmonary

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

Other

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

Expected Enrollment

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

Outcomes

Time to treatment failure at 3 years within the study and then periodically after study completion

Complete response rate at 3 years within the study and then periodically after study completion
Progression rate
Survival
Tumor control
Disease-free survival

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.

Pfreundschuh M, Schubert J, Ziepert M, et al.: Six versus eight cycles of bi-weekly CHOP-14 with or without rituximab in elderly patients with aggressive CD20+ B-cell lymphomas: a randomised controlled trial (RICOVER-60). Lancet Oncol 9 (2): 105-16, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

German High-Grade Non-Hodgkin's Lymphoma Study Group

Michael Pfreundschuh, MD, Protocol chair		Ph: 49-6841-162-3084 Email: michael.pfreundschuh@uniklinik-saarland.de

Germany
	Aachen
	Haematologisch Onkologische Praxis
		D. Tummes, MD	Ph:  49-241-50-0051
			Email: tummes@onkologie-aachen.de
	Amberg
	Klinikum St. Marien
		Contact Person	Ph:  49-9621-380
	Ansbach
	Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
		Sebastian Mueller, MD	Ph:  49-981-970-790
			Email: onkologie-ansbach@t-online.de
	Aschaffenburg
	II. Medizinische Klinik
		Contact Person	Ph:  49-6021-320
	Specialist Practice for Oncology
		Martine Klausmann, MD	Ph:  49-6021-34270
	Augsburg
	Haematologische Praxis
		Hans Rainer Slawik, MD	Ph:  49-821-513143
	Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg
		Olaf Brudler, MD	Ph:  49-821-344-650
	Klinikum Augsburg
		Contact Person	Ph:  49-82-14-00-01
	Aurich
	Kreiskrankenhaus Aurich
		Contact Person	Ph:  49-4941-94-18-02
	Bad Friedrichshall
	Regional Hospital Am Plattenwald
		Contact Person	Ph:  49-71-36280
	Bad Hersfeld
	Regional Hospital Bad Hersfeld
		Contact Person	Ph:  49-6621-880
	Bad Saarow
	Humaine - Clinic
		Contact Person	Ph:  49-336-3170
	Bayreuth
	Krankenhaus Hohe Warte Mediziniche Klinik
		Contact Person	Ph:  49-921-2800
	Berlin
	Haematologisch-Onkologische Schwerpunktpraxis
		Ilona Blau, MD	Ph:  49-30-461-4857
	Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
		Contact Person	Ph:  49-9417-1492
	Bernburg
	Hospital Complex Bernburg
		Contact Person	Ph:  49-3471-340
	Bietigheim
	Krankenhaus Bietigheim
		Contact Person	Ph:  49-7142-790
	Bocholt
	Saint Agnes Hospital
		Contact Person	Ph:  49-2871-200
	Bochum
	Knappschaft Krankenhaus
		Contact Person	Ph:  49-234-2990
	Saint Josef Hospital
		Contact Person	Ph:  49-234-509421
	Bonn
	Medizinische Poliklinik
		Contact Person	Ph:  49-228-2870
	Rheinische Friedrich-Wilhelms-Universitat
		Contact Person	Ph:  49-228-287-5159
	Bremen
	DIAKO Ev. Diakonie Krankenhaus gGmbH
		Contact Person	Ph:  49-421-6102
	Bunde
	Medizinische Klinik Am Lukas - Krankenhaus
		Contact Person	Ph:  49-52-23-16-70
	Celle
	General Hospital
		Contact Person	Ph:  49-723124
	Chemnitz
	Hospital Kuchwald Chemnitz
		Contact Person	Ph:  49-371-333-42700
	Cologne
	Medizinische Universitaetsklinik I at the University of Cologne
		Contact Person	Ph:  49-221-47-84-40-0
	Praxis Fuer Haematologie Internistische Onkologie
		Stephan Schmitz, MD	Ph:  49 221 932 1620
			Email: schmitz@oncokoeln.de
	Cologne-Kalk
		Stephen Mainka, MD	Ph:  49-221-872-047
	Cologne-Merheim
	Lung Clinic Cologne-Merheim
		Contact Person	Ph:  49-221-89-07
	Cottbus
	Carl - Thiem - Klinkum Cottbus
		Contact Person	Ph:  49-355-460
	Darmstadt
	Klinikum Darmstadt
		Contact Person	Ph:  49-6151-1070
	Dortmund
	Saint Johannes Hospital Dortmund
		Contact Person	Ph:  49-231-18430
	Dresden
	Universitatsklinikum Carl Gustav Carus
		Contact Person	Ph:  49-351-4500
	Duisburg
	St. Johannes Hospital - Medical Klinik II
		Contact Person	Ph:  49-203-5462480
	Dulmen
	Franz Hospital Dulmen
		Contact Person	Ph:  49-2594-9200
	Dusseldorf
	Florence-Nightingale-Krankenhause, Deaconess Kaiserswerth
		Contact Person	Ph:  49-211-4090
	Emden
	Hans - Susemihl - Krankenhaus
		Contact Person	Ph:  49-4921-980
	Erfurt
	Klinikum Erfurt
		Contact Person	Ph:  49-361-78-10
	Eschweiler
	St. Antonius Hospital
		Contact Person	Ph:  49-2403-761280
	Essen
	Universitaetsklinikum Essen
		Contact Person	Ph:  49-201-72311
	Essen-Werden
	Evangelisches Krankenhaus Essen Werden
		Contact Person	Ph:  49-201-40890
	Frankfurt
	Krankenhaus Nordwest
		Contact Person	Ph:  49-69-7601
	Frankfurt/Oder
	Klinikum Frankfurt (Oder) GmbH
		Contact Person	Ph:  49-33-55-480
	Freiburg
	Evang. Deaconess Hospital Freiburg
		Contact Person	Ph:  49-7612700
	Fulda
	Municipal Hospital Complex
		Contact Person	Ph:  49-66-18-40
	Gehrden
	Robert - Koch Hospital
		Contact Person	Ph:  49-5108690
	Gieben
	Centre for Internal Medicine Gieben
		Contact Person	Ph:  49-641994
	Goettingen
	Universitaetsklinikum Goettingen
		Contact Person	Ph:  49-551390
	Greifswald
	Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
		Contact Person	Ph:  49-383477951
	Gutersloh
	Staedtisches Klinikum Guetersloh
		Contact Person	Ph:  49-5241-8324657
	Hagen
	Allgemeines Krankenhaus Hagen
		Contact Person	Ph:  49-23312010
	St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
		Contact Person	Ph:  49-2331
	Halle
	Krankenhaus Martha-Maria Halle-Doelau gGmbH
		Contat Person	Ph:  49-3455590
	Universitaetsklinikum Halle
		Contact Person	Ph:  49-345-5570
	Halle/Saale
	Krankenhaus St. Elisabeth und St. Barbara
		Contact Person	Ph:  49-34521330
	Hamburg
		Wolfgang Zeller, MD	Ph:  49-40-31-43-43
	Allgemeines Krankenhaus Altona
		Contact Person	Ph:  49-40-88220
	Asklepios Klinik Nord Heidberg
		Contact Person	Ph:  49-40-52713449
	Haematologisch-Onkologische Praxis Altona
		Ulrich Kleeberg, MD, PhD	Ph:  49-40-380212
			Email: urkleeberg@hopa-hamburg.de
	University Medical Center Hamburg - Eppendorf
		Contact Person	Ph:  49-40-428030
	Hamm
	Evangelische Krankenhaus Hamm
		Contact Person	Ph:  49-2381-5891333
	Hannover
		Bernd Gaede, MD	Ph:  49-511-302-650
	Henriettenstiftung Krankenhaus
		Contact Person	Ph:  49-511-2893423
	Krankenhaus Siloah - Medizinische Klinik II
		Contat Person	Ph:  49-511-9270
	Medizinische Hochschule Hannover
		Contact Person	Ph:  49-511-53-240
	Harrislee
	Oncology Specialists Clinic
		Wolfgang Grimm, MD	Ph:  49-461-700-0326
			Email: dr.grimm.wolfgang@onlinemed.de
	Heidelberg
	Medizinische Universitaetsklinik und Poliklinik
		Contact Person	Ph:  49-62-21-56-80-11
	Thoraxklinik Heidelberg
		Contact Person	Ph:  49-62213961
	Heidenheim
	Regional Hospital Heidenheim
		Contact Person	Ph:  49-7321330
	Herford
	Klinikum Herford
		Contact Person	Ph:  49-522-19-40
	Herne
	Marienhospital at Ruhr University Bochum
		Contact Person	Ph:  49-232-34-99-13-19
	Herrsching
	Privatklinik Dr. R. Schindlbeck GmbH & Co. KG
		Hermann Dietzfelbinger, MD	Ph:  49-8152-29-260
			Email: h.dietzfelbinger@klinik-schindlbeck.de
	Hildesheim
	Onkologische Schwerpunktpraxis
		Contact Person	Ph:  49-51-21-51-36-55
	Holzminden
	Evang. Hospital
		Contact Person	Ph:  49-5531-7050
	Homburg
	Medical University Hospital Homburg
		Contact Person	Ph:  49-68-41-16-0
	Hoyerswerda
	Hospital Complex Hoyerswerda
		Contact Person	Ph:  49-3571-440
	Jena
	Gemeinschaftspraxis Innere Medizin
		Sabine Hahnfeld, MD	Ph:  49-3641-56246
			Email: SHahnfeld@t-online.de
	Klinikum der Friedrich-Schiller Universitaet Jena
		Contact Person	Ph:  49-36-41-93-91-00
	Kaiserslautern
	Municipal Hospital Complex of the University
		Contact Person	Ph:  49-63-12-030
	Karlsruhe
	Staedtisches Klinikum Karlsruhe gGmbH
		Contact Person	Ph:  49-721-9740
	Kassel
	Red Cross Hospital Kassel
		Contact Person	Ph:  49-561-30860
	Kiel
	Staedtisches Krankenhaus Kiel
		Contact Person	Ph:  49-431-1697
	Koblenz
	Praxis fuer Haematologie und Onkologie
		Hubert Koeppler, MD	Ph:  49-261-304-930
			Email: haem.onc.ko@t-online.de
	Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH
		Contact Person	Ph:  49 261 3170
	Kornwestheim
	Leonardis Clinic
		Contact Person	Ph:  49-221-8907
	Krefeld
	Klinikum Krefeld GmbH
		Contact Person	Ph:  49-21-51-32-28-50
	Kronach
	Frankenwald Klinik
		Contact Person	Ph:  49 9261 590
	Lebach
	Caritas - Krakenhaus Lebach
		Contact Person	Ph:  49 6881 501266
	Leipzig
		Ali Aldaoud, MD	Ph:  49-341-9616-126
	Klinikum "St. Georg" Leipzig
		Contact Person	Ph:  49 341 9090
	University Leipzig Clinic of Internal Medicine
		Contact Person	Ph:  49 341 972
	Lemgo
	Klinikum Lippe - Lemgo
		Contact Person	Ph:  49-52-61-26-41-22
	Limburg
	St. Vincenz Hospital Limburg
		Contact Person	Ph:  49 6431 2920
	Lingen
	St. Bonifatius Hospital Lingen
		Contact Person	Ph:  49-5-91-9100
	Lippstadt
	Dreifaltigkeits Hospital
		Contact Person	Ph:  49 2741 7580
	Ludwigsburg
	Klinikum Ludwigsburg
		Contact Person	Ph:  49-71-41-99-90
	Ludwigshafen
	Municipal Complex of Ludwigshafen
		Contact Person	Ph:  49-62-15-03-0
	St. Marien Hospital Ludwighafen
		Contact Person	Ph:  49 621 55012254
	Luebeck
	Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
		Contact Person	Ph:  49-451-500-0000
	Magdeburg
	Staedtisches Klinikum Magdeburg - Altstadt
		Contact Person	Ph:  49 391 7910
	Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
		Contact Person	Ph:  49-391-672-500
	Mainz
	Johannes Gutenberg University
		Contact Person	Ph:  49 6131 1771
	Mannheim
	III Medizinische Klinik Mannheim
		Contact Person	Ph:  49 21 3833359
	Marburg
		Frank Weidenbach, MD	Ph:  49-6421-9295-0
	Universitaetsklinikum Giessen und Marburg GmbH - Marburg
		Contact Person	Ph:  49-6421-28-62-39
	Mayen
	Regional Hospital Mayen
		Contact Person	Ph:  49 2651 830
	Minden
		Martin Becker, MD
	Klinikum Minden
		Contact Person	Ph:  49-57-18-01-45-01
	Monchengladbach
	Ev. Hospital Bethesda
		Contact Person	Ph:  49 2161 9810
	Hospital Maria-Hilf II
		Contact Person	Ph:  49 2161 892208
	Monchenglasbach/Rheydt
		Ulrich Grabenhorst, MD	Ph:  49-2166-934360
	Mulheim/Ruhr
	Evangelisches Krankenhaus - Mulheim
		Contact Person	Ph:  49 208 3091
	St. Marien Hospital - Muelheim an der Ruhr
		Contact Person	Ph:  49 208 3050
	Munchberg
	Kreiskrankenhaus Muenchberg
		Contact Person	Ph:  49-9281-57-411
	Munich
	Klinikum der Universitaet Muenchen - Grosshadern Campus
		Contact Person	Ph:  49-89-70-95-22-02
	Klinikum der Universitaet Muenchen - Innenstadt Campus
		Contact Person	Ph:  49-89-51-60-22-05
	Krankenhaus Muenchen Schwabing
		Contact Person	Ph:  49-89-30-680
	Munich Oncologic Practice at Elisenhof
		Contact Person	Ph:  49-89-55-07-98-20
	Municipal Hospital Munich
		Contact Person	Ph:  49-89-67-94-26-51
	Munster
	Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
		Contact Person	Ph:  49-251-53-47-617
	Neumarkt
	Regional Hospital Neumarkt
		Contact Person	Ph:  49 9181 4200
	Neunkirchen
	Staedtisches Klinikum Neunkirchen gGmbH
		Contact Person	Ph:  49 6821 180
	Neus
	Lukaskrankenhaus Neuss
		Contact Person	Ph:  49-213-18-88-27-10
	Nuremberg
	Klinikum Nuernberg - Klinikum Nord
		Contact Person	Ph:  49-113-98-24-60
	Offenburg
	Klinikum Offenburg
		Contact Person	Ph:  49-49-78-14-720
	Oldenburg
	Ev. Hospital Oldenburg
		Contact Person	Ph:  49 441 236242
	Hematologische Praxis
		Contact Person	Ph:  49-441-973-6229
	Klinikum Oldenburg
		Contact Person	Ph:  49-44-14-03-26-14
	Osnabrueck
	Paracelsus - Klinik Osnabrueck
		Contact Person	Ph:  49-541-96-60
	Pforzheim
	Municipal Hospital Complex
		Contact Person	Ph:  49-72-31-96-90
	Potsdam
	Klinikum Ernst Von Bergmann
		Contact Person	Ph:  49-331-24-16-002
	Radebeul
	Kreiskrankenhaus Radebeul
		Contact Person	Ph:  49-351-83-30
	Ravensburg
	Krankenhaus St. Elisabeth - Ravensburg
		Contact Person	Ph:  49 751 870
	Regensburg
	Hematologische Onkologische Praxis
		Robert Dengler, MD	Ph:  49 941 466342
			Email: robert.dougler@t-online.de
	Klinikum der Universitaet Regensburg
		Contact Person	Ph:  49-941-2080-0
	Krankenhaus Barmherzige Brueder Regensburg
		Contact Person	Ph:  49-941-36-92-151
	Rheine
	Jakobi Krankenhaus
		Contact Person	Ph:  49 5971 460
	Rostock
		Volker Lakner, MD	Ph:  49-381-493-4276
	Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
		Contact Person	Ph:  49 381 4947408
	Klinik und Poliklinik fuer Strahlentherapie - Universitaetsklinikum Rostock
		Contact Person	Ph:  49-381-44-010
	Saarbrucken
	Caritasklinik St. Theresia
		Contact Person	Ph:  49 681 406461
	Saarbruecken
	Schwerpunktpraxis fuer Haematologie und Onkologie
		Generic Person	Ph:  49-681-473-575
			Email: praxis@onkosaar.de
	Saarlouis
	St. Elizabeth-Klinik Saarlouis
		Contact Person	Ph:  49 6831 160
	Schleswig
	Martin - Luther Hospital
		Contact Person	Ph:  49-46-21-81-20
	Schwabisch Hall
	Deaconess Hospital
		Contact Person	Ph:  49 791 7531
	Schweinfurt
	Leopoldina - Krankenhaus
		Contact Person	Ph:  49-97-17-20-31-11
	Siegen
	Evang. Jung-Stilling Hospital
		Contact Person	Ph:  49 271 3333
	Solingen
	St. Lukas - Clinic Solingen
		Contact Person	Ph:  49 212 7051
	Stuttgart
	Diakonie Klinikum Stuttgart
		Contact Person	Ph:  49 711 9910
	Hospital Bad Cannstatt
		Contact Person	Ph:  49 711 52050
	Klinik fuer Onkologie - Katharinenhospital Stuttgart
		Contact Person	Ph:  49 711 278 5601
	Klinikum Stuttgart - Buergerhospital
		Contact Person	Ph:  49 711 253 2000
	Robert-Bosch-Krankenhaus
		Contact Person	Ph:  49 711 81010
	Thuine
	St. Elisabeth Hospital Thuine
		Contact Person	Ph:  49 5902 9510
	Traunstein
	Regional Hospital Traunstein
		Contact Person	Ph:  49 861 988760
	Trier
		Monika Grundheber, MD	Ph:  49-65-147-479
			Email: dr.med.monikagrundheber@t-online.de
	Krankenanstalt Mutterhaus der Borromaerinnen
		Contact Person	Ph:  49-651-94-72-377
	Krankenhaus Barmherzigen Brueder
		Contact Person	Ph:  49-651-20-80
	Tutzing
	Hospital Tutzing
		Contact Person	Ph:  49 8158 230
	Ulm
	Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
		Contact Person	Ph:  49 731 5024391
	Unna
	Ev. Hospital Unna
		Contact Person	Ph:  49 2303 106 385
	Vechta
	St. Marienhospital - Vechta
		Contact Person	Ph:  49 444 1990
	Villingen-Schwenningen
	Municipal Hospital Complex
		Contact Person	Ph:  49-77-21-930
	Waldbrol
	Regional Hospital Waldbrol
		Contact Person	Ph:  49 2291 821313
	Wetzlar
	Hospital Wetzler
		Contact Person	Ph:  49 644 1791
	Wiesbaden
	Deutsche Klinik fuer Diagnostik
		Contact Person	Ph:  49 611 577648
	Dr. Horst-Schmidt-Kliniken
		Contact Person	Ph:  49 611 433009
	Witten
	Ev. Hospital Witten-Herdecke
		Contact Person	Ph:  49 42302 1750
	Wuppertal
	Kliniken St. Antonius
		Contact Person	Ph:  49 202 2992595
	Wurzburg
	University Wurzburg
		Contact Person	Ph:  49 931 201 7007
	Zwickau
	Municipal Hospital Complex Zwickau
		Contact Person	Ph:  49- 37-55-10
Switzerland
	Zurich
	City Hospital Triemli
		Contact Person	Ph:  41 14662202
	UniversitaetsSpital Zuerich
		Contact Person	Ph:  41 1255 1111

Registry Information
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
Trial Start Date		2001-01-04
Registered in ClinicalTrials.gov		NCT00052936
Date Submitted to PDQ		2002-11-12
Information Last Verified		2007-06-01

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