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

NCT ID: NCT00052936

Last Updated: 2021-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1506 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2010-08-05

Brief Summary

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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).

Detailed Description

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OBJECTIVES:

Primary

* 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.

Secondary

* 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.

Conditions

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Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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S6

6x CHOP-14

Group Type EXPERIMENTAL

filgrastim

Intervention Type BIOLOGICAL

CHOP regimen

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

prednisone

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

36Gy on BULK and extranodal involvement

R6

6x CHOP-14 + 8x Rituximab

Group Type EXPERIMENTAL

filgrastim

Intervention Type BIOLOGICAL

rituximab

Intervention Type BIOLOGICAL

CHOP regimen

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

prednisone

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

36Gy on BULK and extranodal involvement

S8

8x CHOP-14

Group Type EXPERIMENTAL

filgrastim

Intervention Type BIOLOGICAL

CHOP regimen

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

prednisone

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

36Gy on BULK and extranodal involvement

R8

8x CHOP-14 + 8x Rituximab

Group Type EXPERIMENTAL

filgrastim

Intervention Type BIOLOGICAL

rituximab

Intervention Type BIOLOGICAL

CHOP regimen

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

prednisone

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

36Gy on BULK and extranodal involvement

Interventions

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filgrastim

Intervention Type BIOLOGICAL

rituximab

Intervention Type BIOLOGICAL

CHOP regimen

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

prednisone

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

radiation therapy

36Gy on BULK and extranodal involvement

Intervention Type RADIATION

Eligibility Criteria

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Inclusion 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

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/mm\^3
* Platelet count at least 100,000/mm\^3

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

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
Minimum Eligible Age

61 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael G.M. Pfreundschuh, MD

Role: STUDY_CHAIR

Universitaetsklinikum des Saarlandes

Locations

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Haematologisch Onkologische Praxis

Aachen, , Germany

Site Status

Klinikum St. Marien

Amberg, , Germany

Site Status

Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie

Ansbach, , Germany

Site Status

II. Medizinische Klinik

Aschaffenburg, , Germany

Site Status

Specialist Practice for Oncology

Aschaffenburg, , Germany

Site Status

Haematologische Praxis

Augsburg, , Germany

Site Status

Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg

Augsburg, , Germany

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Klinikum Augsburg

Augsburg, , Germany

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Kreiskrankenhaus Aurich

Aurich, , Germany

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Regional Hospital Bad Hersfeld

Bad Hersfeld, , Germany

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Humaine - Clinic

Bad Saarow, , Germany

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Krankenhaus Hohe Warte Mediziniche Klinik

Bayreuth, , Germany

Site Status

Robert Roessle Comprehensive Cancer Center - Charite Campus Buch

Berlin, , Germany

Site Status

Haematologisch-Onkologische Schwerpunktpraxis

Berlin, , Germany

Site Status

Hospital Complex Bernburg

Bernburg, , Germany

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Krankenhaus Bietigheim

Bietigheim, , Germany

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Saint Agnes Hospital

Bocholt, , Germany

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Saint Josef Hospital

Bochum, , Germany

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Knappschaft Krankenhaus

Bochum, , Germany

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Medizinische Poliklinik

Bonn, , Germany

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Rheinische Friedrich-Wilhelms-Universitat

Bonn, , Germany

Site Status

DIAKO Ev. Diakonie Krankenhaus gGmbH

Bremen, , Germany

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Medizinische Klinik Am Lukas - Krankenhaus

Bünde, , Germany

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General Hospital

Celle, , Germany

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Hospital Kuchwald Chemnitz

Chemnitz, , Germany

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Praxis Fuer Haematologie Internistische Onkologie

Cologne, , Germany

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Medizinische Universitaetsklinik I at the University of Cologne

Cologne, , Germany

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Cologne-Kalk, , Germany

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Lung Clinic Cologne-Merheim

Cologne-Merheim, , Germany

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Carl - Thiem - Klinkum Cottbus

Cottbus, , Germany

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Klinikum Darmstadt

Darmstadt, , Germany

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Saint Johannes Hospital Dortmund

Dortmund, , Germany

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Universitatsklinikum Carl Gustav Carus

Dresden, , Germany

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St. Johannes Hospital - Medical Klinik II

Duisburg, , Germany

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Franz Hospital Dulmen

Dülmen, , Germany

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Florence-Nightingale-Krankenhause, Deaconess Kaiserswerth

Düsseldorf, , Germany

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Hans - Susemihl - Krankenhaus

Emden, , Germany

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Klinikum Erfurt

Erfurt, , Germany

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St. Antonius Hospital

Eschweiler, , Germany

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Universitaetsklinikum Essen

Essen, , Germany

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Krankenhaus Nordwest

Frankfurt, , Germany

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Klinikum Frankfurt (Oder) GmbH

Frankfurt (Oder), , Germany

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Evang. Deaconess Hospital Freiburg

Freiburg im Breisgau, , Germany

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Municipal Hospital Complex

Fulda, , Germany

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Robert - Koch Hospital

Gehrden, , Germany

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Centre for Internal Medicine Gieben

Giessen, , Germany

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Universitaetsklinikum Goettingen

Göttingen, , Germany

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

Greifswald, , Germany

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Staedtisches Klinikum Guetersloh

Gütersloh, , Germany

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Allgemeines Krankenhaus Hagen

Hagen, , Germany

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St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

Hagen, , Germany

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Krankenhaus St. Elisabeth und St. Barbara

Halle, , Germany

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Krankenhaus Martha-Maria Halle-Doelau gGmbH

Halle, , Germany

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Universitaetsklinikum Halle

Halle, , Germany

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Hamburg, , Germany

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University Medical Center Hamburg - Eppendorf

Hamburg, , Germany

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Asklepios Klinik Nord Heidberg

Hamburg, , Germany

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Allgemeines Krankenhaus Altona

Hamburg, , Germany

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Haematologisch-Onkologische Praxis Altona

Hamburg, , Germany

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Evangelische Krankenhaus Hamm

Hamm, , Germany

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Hanover, , Germany

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Henriettenstiftung Krankenhaus

Hanover, , Germany

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Krankenhaus Siloah - Medizinische Klinik II

Hanover, , Germany

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Medizinische Hochschule Hannover

Hanover, , Germany

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Oncology Specialists Clinic

Harrislee, , Germany

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Thoraxklinik Heidelberg

Heidelberg, , Germany

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Medizinische Universitaetsklinik und Poliklinik

Heidelberg, , Germany

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Regional Hospital Heidenheim

Heidenheim, , Germany

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Regional Hospital Am Plattenwald - Bad Friedrichshall

Heilbronn, , Germany

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Klinikum Herford

Herford, , Germany

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Marienhospital at Ruhr University Bochum

Herne, , Germany

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Privatklinik Dr. R. Schindlbeck GmbH & Co. KG

Herrsching am Ammersee, , Germany

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Onkologische Schwerpunktpraxis

Hildesheim, , Germany

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Evang. Hospital

Holzminden, , Germany

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Medical University Hospital Homburg

Homburg, , Germany

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Hospital Complex Hoyerswerda

Hoyerswerda, , Germany

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Gemeinschaftspraxis Innere Medizin

Jena, , Germany

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Klinikum der Friedrich-Schiller Universitaet Jena

Jena, , Germany

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Municipal Hospital Complex of the University

Kaiserslautern, , Germany

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Staedtisches Klinikum Karlsruhe gGmbH

Karlsruhe, , Germany

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Red Cross Hospital Kassel

Kassel, , Germany

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Staedtisches Krankenhaus Kiel

Kiel, , Germany

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Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH

Koblenz, , Germany

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Praxis fuer Haematologie und Onkologie

Koblenz, , Germany

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Leonardis Clinic

Kornwestheim, , Germany

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Klinikum Krefeld GmbH

Krefeld, , Germany

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Frankenwald Klinik

Kronach, , Germany

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Caritas - Krakenhaus Lebach

Lebach, , Germany

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University Leipzig Clinic of Internal Medicine

Leipzig, , Germany

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Klinikum "St. Georg" Leipzig

Leipzig, , Germany

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Leipzig, , Germany

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Klinikum Lippe - Lemgo

Lemgo, , Germany

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St. Vincenz Hospital Limburg

Limburg, , Germany

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St. Bonifatius Hospital Lingen

Lingen, , Germany

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Dreifaltigkeits Hospital

Lippstadt, , Germany

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Klinikum Ludwigsburg

Ludwigsburg, , Germany

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St. Marien Hospital Ludwighafen

Ludwigshafen, , Germany

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Municipal Complex of Ludwigshafen

Ludwigshafen, , Germany

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Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

Lübeck, , Germany

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Staedtisches Klinikum Magdeburg - Altstadt

Magdeburg, , Germany

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Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

Magdeburg, , Germany

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Johannes Gutenberg University

Mainz, , Germany

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III Medizinische Klinik Mannheim

Mannheim, , Germany

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Marburg, , Germany

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Universitaetsklinikum Giessen und Marburg GmbH - Marburg

Marburg, , Germany

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Regional Hospital Mayen

Mayen, , Germany

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Klinikum Minden

Minden, , Germany

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Minden, , Germany

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Monchenglasbach/Rheydt, , Germany

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Ev. Hospital Bethesda

Mönchengladbach, , Germany

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Hospital Maria-Hilf II

Mönchengladbach, , Germany

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Munich Oncologic Practice at Elisenhof

Munich, , Germany

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Klinikum der Universitaet Muenchen - Innenstadt Campus

Munich, , Germany

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Krankenhaus Muenchen Schwabing

Munich, , Germany

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Klinikum der Universitaet Muenchen - Grosshadern Campus

Munich, , Germany

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Municipal Hospital Munich

Munich, , Germany

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Evangelisches Krankenhaus - Mulheim

Mülheim, , Germany

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St. Marien Hospital - Muelheim an der Ruhr

Mülheim, , Germany

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Kreiskrankenhaus Muenchberg

Münchberg, , Germany

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Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster

Münster, , Germany

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Regional Hospital Neumarkt

Neumarkt, , Germany

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Staedtisches Klinikum Neunkirchen gGmbH

Neunkirchen, , Germany

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Lukaskrankenhaus Neuss

Neuss, , Germany

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Klinikum Nuernberg - Klinikum Nord

Nuremberg, , Germany

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Klinikum Offenburg

Offenburg, , Germany

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Hematologische Praxis

Oldenburg, , Germany

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Ev. Hospital Oldenburg

Oldenburg, , Germany

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Klinikum Oldenburg

Oldenburg, , Germany

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Paracelsus - Klinik Osnabrueck

Osnabrück, , Germany

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Municipal Hospital Complex

Pforzheim, , Germany

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Klinikum Ernst Von Bergmann

Potsdam, , Germany

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Kreiskrankenhaus Radebeul

Radebeul, , Germany

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Krankenhaus St. Elisabeth - Ravensburg

Ravensburg, , Germany

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Klinikum der Universitaet Regensburg

Regensburg, , Germany

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Hematologische Onkologische Praxis

Regensburg, , Germany

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Krankenhaus Barmherzige Brueder Regensburg

Regensburg, , Germany

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Jakobi Krankenhaus

Rheine, , Germany

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Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock

Rostock, , Germany

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Klinik und Poliklinik fuer Strahlentherapie - Universitaetsklinikum Rostock

Rostock, , Germany

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Rostock, , Germany

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Caritasklinik St. Theresia

Saarbrücken, , Germany

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Schwerpunktpraxis fuer Haematologie und Onkologie

Saarbrücken, , Germany

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St. Elizabeth-Klinik Saarlouis

Saarlouis, , Germany

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Martin - Luther Hospital

Schleswig, , Germany

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Deaconess Hospital

Schwäbisch Hall, , Germany

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Leopoldina - Krankenhaus

Schweinfurt, , Germany

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Evang. Jung-Stilling Hospital

Siegen, , Germany

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St. Lukas - Clinic Solingen

Solingen, , Germany

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Klinik fuer Onkologie - Katharinenhospital Stuttgart

Stuttgart, , Germany

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Diakonie Klinikum Stuttgart

Stuttgart, , Germany

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Klinikum Stuttgart - Buergerhospital

Stuttgart, , Germany

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Hospital Bad Cannstatt

Stuttgart, , Germany

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Robert-Bosch-Krankenhaus

Stuttgart, , Germany

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St. Elisabeth Hospital Thuine

Thuine, , Germany

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Regional Hospital Traunstein

Traunstein, , Germany

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Krankenanstalt Mutterhaus der Borromaerinnen

Trier, , Germany

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Trier, , Germany

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Krankenhaus Barmherzigen Brueder

Trier, , Germany

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Hospital Tutzing

Tutzing, , Germany

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Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Ulm, , Germany

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Ev. Hospital Unna

Unna, , Germany

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St. Marienhospital - Vechta

Vechta, , Germany

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Municipal Hospital Complex

Villingen-Schwenningen, , Germany

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Regional Hospital Waldbrol

Waldbröl, , Germany

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Evangelisches Krankenhaus Essen Werden

Werden, , Germany

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Hospital Wetzler

Wetzlar, , Germany

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Deutsche Klinik fuer Diagnostik

Wiesbaden, , Germany

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Dr. Horst-Schmidt-Kliniken

Wiesbaden, , Germany

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Ev. Hospital Witten-Herdecke

Witten, , Germany

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Kliniken St. Antonius

Wuppertal, , Germany

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University Wurzburg

Würzburg, , Germany

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Municipal Hospital Complex Zwickau

Zwickau, , Germany

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City Hospital Triemli

Zurich, , Switzerland

Site Status

UniversitaetsSpital Zuerich

Zurich, , Switzerland

Site Status

Countries

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Germany Switzerland

References

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Pfreundschuh M, Schubert J, Ziepert M, Schmits R, Mohren M, Lengfelder E, Reiser M, Nickenig C, Clemens M, Peter N, Bokemeyer C, Eimermacher H, Ho A, Hoffmann M, Mertelsmann R, Trumper L, Balleisen L, Liersch R, Metzner B, Hartmann F, Glass B, Poeschel V, Schmitz N, Ruebe C, Feller AC, Loeffler M; German High-Grade Non-Hodgkin Lymphoma Study Group (DSHNHL). 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. 2008 Feb;9(2):105-16. doi: 10.1016/S1470-2045(08)70002-0. Epub 2008 Jan 15.

Reference Type RESULT
PMID: 18226581 (View on PubMed)

Christofyllakis K, Kaddu-Mulindwa D, Lesan V, Rixecker T, Kos IA, Held G, Regitz E, Pfreundschuh M, Bittenbring JT, Thurner L, Poeschel V, Ziepert M, Altmann B, Bewarder M. An inherited genetic variant of the CEP72 gene is associated with the development of vincristine-induced peripheral neuropathy in female patients with aggressive B-cell lymphoma. Ann Hematol. 2024 Nov;103(11):4599-4606. doi: 10.1007/s00277-024-05973-9. Epub 2024 Sep 4.

Reference Type DERIVED
PMID: 39227453 (View on PubMed)

Kuhnl A, Cunningham D, Counsell N, Hawkes EA, Qian W, Smith P, Chadwick N, Lawrie A, Mouncey P, Jack A, Pocock C, Ardeshna KM, Radford J, McMillan A, Davies J, Turner D, Kruger A, Johnson PW, Gambell J, Rosenwald A, Ott G, Horn H, Ziepert M, Pfreundschuh M, Linch D. Outcome of elderly patients with diffuse large B-cell lymphoma treated with R-CHOP: results from the UK NCRI R-CHOP14v21 trial with combined analysis of molecular characteristics with the DSHNHL RICOVER-60 trial. Ann Oncol. 2017 Jul 1;28(7):1540-1546. doi: 10.1093/annonc/mdx128.

Reference Type DERIVED
PMID: 28398499 (View on PubMed)

Pfreundschuh M, Poeschel V, Zeynalova S, Hanel M, Held G, Schmitz N, Viardot A, Dreyling MH, Hallek M, Mueller C, Wiesen MH, Witzens-Harig M, Truemper L, Keller U, Rixecker T, Zwick C, Murawski N. Optimization of rituximab for the treatment of diffuse large B-cell lymphoma (II): extended rituximab exposure time in the SMARTE-R-CHOP-14 trial of the german high-grade non-Hodgkin lymphoma study group. J Clin Oncol. 2014 Dec 20;32(36):4127-33. doi: 10.1200/JCO.2013.54.6861. Epub 2014 Nov 17.

Reference Type DERIVED
PMID: 25403207 (View on PubMed)

Bittenbring JT, Neumann F, Altmann B, Achenbach M, Reichrath J, Ziepert M, Geisel J, Regitz E, Held G, Pfreundschuh M. Vitamin D deficiency impairs rituximab-mediated cellular cytotoxicity and outcome of patients with diffuse large B-cell lymphoma treated with but not without rituximab. J Clin Oncol. 2014 Oct 10;32(29):3242-8. doi: 10.1200/JCO.2013.53.4537. Epub 2014 Aug 18.

Reference Type DERIVED
PMID: 25135997 (View on PubMed)

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Horn H, Ziepert M, Becher C, Barth TF, Bernd HW, Feller AC, Klapper W, Hummel M, Stein H, Hansmann ML, Schmelter C, Moller P, Cogliatti S, Pfreundschuh M, Schmitz N, Trumper L, Siebert R, Loeffler M, Rosenwald A, Ott G; German High-Grade Non-Hodgkin Lymphoma Study Group. MYC status in concert with BCL2 and BCL6 expression predicts outcome in diffuse large B-cell lymphoma. Blood. 2013 Mar 21;121(12):2253-63. doi: 10.1182/blood-2012-06-435842. Epub 2013 Jan 18.

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Muller C, Murawski N, Wiesen MH, Held G, Poeschel V, Zeynalova S, Wenger M, Nickenig C, Peter N, Lengfelder E, Metzner B, Rixecker T, Zwick C, Pfreundschuh M, Reiser M. The role of sex and weight on rituximab clearance and serum elimination half-life in elderly patients with DLBCL. Blood. 2012 Apr 5;119(14):3276-84. doi: 10.1182/blood-2011-09-380949. Epub 2012 Feb 15.

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DSHNHL-1999-1A

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EU-20243

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000269015

Identifier Type: -

Identifier Source: org_study_id

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