AzTrials
AzTrials

LymphomaPhase 3NCT00052936

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

A Phase 3 study testing filgrastim, rituximab and CHOP regimen in people with Lymphoma, run by German High-Grade Non-Hodgkin's Lymphoma Study Group at 174 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 61 to 80 years
Conditions the study is for
Lymphoma
What is being tested?
filgrastim, rituximab and CHOP regimen
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,506 participants
Where
174 sitesin 2 countries
Study dates
Jan 2001to 5 Aug 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 61 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

174 sites in 2 countries.

174 sites in 2 countries

Germany172 sites

  • Haematologisch Onkologische Praxis

    Aachen, 52070

  • Klinikum St. Marien

    Amberg, D-92224

  • Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie

    Ansbach, 91522

  • II. Medizinische Klinik

    Aschaffenburg, 63739

  • Specialist Practice for Oncology

    Aschaffenburg, 63739

  • Haematologische Praxis

    Augsburg, 86150

  • Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg

    Augsburg, 86150

  • Klinikum Augsburg

    Augsburg, D-86156

  • Kreiskrankenhaus Aurich

    Aurich, D-26603

  • Regional Hospital Bad Hersfeld

    Bad Hersfeld, 36251

  • Humaine - Clinic

    Bad Saarow, 15523

  • Krankenhaus Hohe Warte Mediziniche Klinik

    Bayreuth, D-95445

  • Robert Roessle Comprehensive Cancer Center - Charite Campus Buch

    Berlin, 13125

  • Haematologisch-Onkologische Schwerpunktpraxis

    Berlin, 13357

  • Hospital Complex Bernburg

    Bernburg, 06406

  • Krankenhaus Bietigheim

    Bietigheim, D-74321

  • Saint Agnes Hospital

    Bocholt, 46397

  • Saint Josef Hospital

    Bochum, 44791

  • Knappschaft Krankenhaus

    Bochum, D-44892

  • Medizinische Poliklinik

    Bonn, D-53111

  • Rheinische Friedrich-Wilhelms-Universitat

    Bonn, D-53113

  • DIAKO Ev. Diakonie Krankenhaus gGmbH

    Bremen, 28239

  • Medizinische Klinik Am Lukas - Krankenhaus

    Bünde, D-32257

  • General Hospital

    Celle, 29223

  • Hospital Kuchwald Chemnitz

    Chemnitz, 09113

  • Praxis Fuer Haematologie Internistische Onkologie

    Cologne, D-50677

  • Medizinische Universitaetsklinik I at the University of Cologne

    Cologne, D-50924

  • Study site

    Cologne-Kalk, D-51105

  • Lung Clinic Cologne-Merheim

    Cologne-Merheim, D-51109

  • Carl - Thiem - Klinkum Cottbus

    Cottbus, 03048

  • Klinikum Darmstadt

    Darmstadt, D-64283

  • Saint Johannes Hospital Dortmund

    Dortmund, 44137

  • Universitatsklinikum Carl Gustav Carus

    Dresden, D-01307

  • St. Johannes Hospital - Medical Klinik II

    Duisburg, 47166

  • Franz Hospital Dulmen

    Dülmen, 48249

  • Florence-Nightingale-Krankenhause, Deaconess Kaiserswerth

    Düsseldorf, 40489

  • Hans - Susemihl - Krankenhaus

    Emden, 26721

  • Klinikum Erfurt

    Erfurt, D-99089

  • St. Antonius Hospital

    Eschweiler, 52249

  • Universitaetsklinikum Essen

    Essen, 45147

  • Krankenhaus Nordwest

    Frankfurt, D-60488

  • Klinikum Frankfurt (Oder) GmbH

    Frankfurt (Oder), D-15236

  • Evang. Deaconess Hospital Freiburg

    Freiburg im Breisgau, 79110

  • Municipal Hospital Complex

    Fulda, D-36043

  • Robert - Koch Hospital

    Gehrden, 30989

  • Centre for Internal Medicine Gieben

    Giessen, 35392

  • Universitaetsklinikum Goettingen

    Göttingen, 37075

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

    Greifswald, 17489

  • Staedtisches Klinikum Guetersloh

    Gütersloh, 33332

  • Allgemeines Krankenhaus Hagen

    Hagen, 58095

  • St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

    Hagen, 58095

  • Krankenhaus St. Elisabeth und St. Barbara

    Halle, 06110

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH

    Halle, 06120

  • Universitaetsklinikum Halle

    Halle, D-06120

  • Study site

    Hamburg, 20095

  • University Medical Center Hamburg - Eppendorf

    Hamburg, 20251

  • Asklepios Klinik Nord Heidberg

    Hamburg, 22413

  • Allgemeines Krankenhaus Altona

    Hamburg, 22763

  • Haematologisch-Onkologische Praxis Altona

    Hamburg, D-22767

  • Evangelische Krankenhaus Hamm

    Hamm, 59063

  • Study site

    Hanover, 30159

  • Henriettenstiftung Krankenhaus

    Hanover, 30559

  • Krankenhaus Siloah - Medizinische Klinik II

    Hanover, D-30449

  • Medizinische Hochschule Hannover

    Hanover, D-30625

  • Oncology Specialists Clinic

    Harrislee, D-24955

  • Thoraxklinik Heidelberg

    Heidelberg, 69126

  • Medizinische Universitaetsklinik und Poliklinik

    Heidelberg, D-69115

  • Regional Hospital Heidenheim

    Heidenheim, 89522

  • Regional Hospital Am Plattenwald - Bad Friedrichshall

    Heilbronn, 74177

  • Klinikum Herford

    Herford, D-32049

  • Marienhospital at Ruhr University Bochum

    Herne, D-44625

  • Privatklinik Dr. R. Schindlbeck GmbH & Co. KG

    Herrsching am Ammersee, D-82211

  • Onkologische Schwerpunktpraxis

    Hildesheim, D-31134

  • Evang. Hospital

    Holzminden, 37603

  • Medical University Hospital Homburg

    Homburg, D-66421

  • Hospital Complex Hoyerswerda

    Hoyerswerda, 02977

  • Gemeinschaftspraxis Innere Medizin

    Jena, D-07743

  • Klinikum der Friedrich-Schiller Universitaet Jena

    Jena, D-07747

  • Municipal Hospital Complex of the University

    Kaiserslautern, D-67655

  • Staedtisches Klinikum Karlsruhe gGmbH

    Karlsruhe, 76133

  • Red Cross Hospital Kassel

    Kassel, 34121

  • Staedtisches Krankenhaus Kiel

    Kiel, 23116

  • Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH

    Koblenz, 56068

  • Praxis fuer Haematologie und Onkologie

    Koblenz, D-56068

  • Leonardis Clinic

    Kornwestheim, D-70806

  • Klinikum Krefeld GmbH

    Krefeld, D-47805

  • Frankenwald Klinik

    Kronach, 96317

  • Caritas - Krakenhaus Lebach

    Lebach, 66822

  • University Leipzig Clinic of Internal Medicine

    Leipzig, 04103

  • Klinikum "St. Georg" Leipzig

    Leipzig, 04129

  • Study site

    Leipzig, D-04103

  • Klinikum Lippe - Lemgo

    Lemgo, D-32657

  • St. Vincenz Hospital Limburg

    Limburg, 65549

  • St. Bonifatius Hospital Lingen

    Lingen, 49808

  • Dreifaltigkeits Hospital

    Lippstadt, 59555

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lübeck, D-23538

  • Klinikum Ludwigsburg

    Ludwigsburg, D-71640

  • St. Marien Hospital Ludwighafen

    Ludwigshafen, 67067

  • Municipal Complex of Ludwigshafen

    Ludwigshafen, D-67063

  • Staedtisches Klinikum Magdeburg - Altstadt

    Magdeburg, 39104

  • Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

    Magdeburg, 39120

  • Johannes Gutenberg University

    Mainz, 55131

  • III Medizinische Klinik Mannheim

    Mannheim, D-68305

  • Study site

    Marburg, D-35037

  • Universitaetsklinikum Giessen und Marburg GmbH - Marburg

    Marburg, D-35043

  • Regional Hospital Mayen

    Mayen, 56727

  • Klinikum Minden

    Minden, D-32423

  • Study site

    Minden, D-32427

  • Ev. Hospital Bethesda

    Mönchengladbach, 41061

  • Hospital Maria-Hilf II

    Mönchengladbach, 41063

  • Study site

    Monchenglasbach/Rheydt, D-41239

  • Evangelisches Krankenhaus - Mulheim

    Mülheim, 45466

  • St. Marien Hospital - Muelheim an der Ruhr

    Mülheim, 45468

  • Kreiskrankenhaus Muenchberg

    Münchberg, 95213

  • Munich Oncologic Practice at Elisenhof

    Munich, D-80335

  • Klinikum der Universitaet Muenchen - Innenstadt Campus

    Munich, D-80336

  • Krankenhaus Muenchen Schwabing

    Munich, D-80804

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377

  • Municipal Hospital Munich

    Munich, D-81737

  • Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster

    Münster, D-48129

  • Regional Hospital Neumarkt

    Neumarkt, 92318

  • Staedtisches Klinikum Neunkirchen gGmbH

    Neunkirchen, 66538

  • Lukaskrankenhaus Neuss

    Neuss, D-41464

  • Klinikum Nuernberg - Klinikum Nord

    Nuremberg, D-90340

  • Klinikum Offenburg

    Offenburg, D-77654

  • Hematologische Praxis

    Oldenburg, 26121

  • Ev. Hospital Oldenburg

    Oldenburg, 26122

  • Klinikum Oldenburg

    Oldenburg, D-26133

  • Paracelsus - Klinik Osnabrueck

    Osnabrück, D-49076

  • Municipal Hospital Complex

    Pforzheim, D-75175

  • Klinikum Ernst Von Bergmann

    Potsdam, D-14467

  • Kreiskrankenhaus Radebeul

    Radebeul, D-01445

  • Krankenhaus St. Elisabeth - Ravensburg

    Ravensburg, 88212

  • Klinikum der Universitaet Regensburg

    Regensburg, 93042

  • Hematologische Onkologische Praxis

    Regensburg, 93047

  • Krankenhaus Barmherzige Brueder Regensburg

    Regensburg, D-93049

  • Jakobi Krankenhaus

    Rheine, 48431

  • Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock

    Rostock, 18057

  • Klinik und Poliklinik fuer Strahlentherapie - Universitaetsklinikum Rostock

    Rostock, 18059

  • Study site

    Rostock, D-18257

  • Caritasklinik St. Theresia

    Saarbrücken, 66113

  • Schwerpunktpraxis fuer Haematologie und Onkologie

    Saarbrücken, D-66113

  • St. Elizabeth-Klinik Saarlouis

    Saarlouis, 66713

  • Martin - Luther Hospital

    Schleswig, D-24837

  • Deaconess Hospital

    Schwäbisch Hall, 74523

  • Leopoldina - Krankenhaus

    Schweinfurt, D-97422

  • Evang. Jung-Stilling Hospital

    Siegen, 57074

  • St. Lukas - Clinic Solingen

    Solingen, 42697

  • Klinik fuer Onkologie - Katharinenhospital Stuttgart

    Stuttgart, 70174

  • Diakonie Klinikum Stuttgart

    Stuttgart, 70176

  • Klinikum Stuttgart - Buergerhospital

    Stuttgart, 70191

  • Hospital Bad Cannstatt

    Stuttgart, 70374

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

  • St. Elisabeth Hospital Thuine

    Thuine, 49832

  • Regional Hospital Traunstein

    Traunstein, 83278

  • Krankenanstalt Mutterhaus der Borromaerinnen

    Trier, D-54290

  • Study site

    Trier, D-54290

  • Krankenhaus Barmherzigen Brueder

    Trier, D-54292

  • Hospital Tutzing

    Tutzing, 82327

  • Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

    Ulm, 89081

  • Ev. Hospital Unna

    Unna, 59403

  • St. Marienhospital - Vechta

    Vechta, 49377

  • Municipal Hospital Complex

    Villingen-Schwenningen, D-78045

  • Regional Hospital Waldbrol

    Waldbröl, 51545

  • Evangelisches Krankenhaus Essen Werden

    Werden, 45239

  • Hospital Wetzler

    Wetzlar, 35578

  • Deutsche Klinik fuer Diagnostik

    Wiesbaden, 65191

  • Dr. Horst-Schmidt-Kliniken

    Wiesbaden, 65199

  • Ev. Hospital Witten-Herdecke

    Witten, 58455

  • Kliniken St. Antonius

    Wuppertal, 42283

  • University Wurzburg

    Würzburg, 97070

  • Municipal Hospital Complex Zwickau

    Zwickau, D-08060

Other trials in Germany

Switzerland2 sites

  • City Hospital Triemli

    Zurich, 8063

  • UniversitaetsSpital Zuerich

    Zurich, 8091

Other trials in Switzerland

About this study

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

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).

Read the detailed description

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
Lymphoma
Keywords
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
Medical subject headings
Lymphoma, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Lymphoma, Follicular, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00052936
Study groupRoleWhat they receive
S6Experimental6x CHOP-14
Receives: Biological: filgrastim; Drug: CHOP regimen; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisone; Drug: vincristine sulfate; Radiation: radiation therapy
R6Experimental6x CHOP-14 + 8x Rituximab
Receives: Biological: filgrastim; Biological: rituximab; Drug: CHOP regimen; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisone; Drug: vincristine sulfate; Radiation: radiation therapy
S8Experimental8x CHOP-14
Receives: Biological: filgrastim; Drug: CHOP regimen; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisone; Drug: vincristine sulfate; Radiation: radiation therapy
R8Experimental8x CHOP-14 + 8x Rituximab
Receives: Biological: filgrastim; Biological: rituximab; Drug: CHOP regimen; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisone; Drug: vincristine sulfate; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 years within the study and then periodically after study completion

Secondary outcomes (5)

  1. Complete response rate at 3 years within the study and then periodically after study completion

    Measured: 3 years within the study and then periodically after

  2. Progression rate

    Measured: 3 years within the study and then periodically after

  3. Survival

    Measured: 3 years within the study and then periodically after

  4. Tumor control

    Measured: 3 years within the study and then periodically after

  5. Disease-free survival

    Measured: 3 years within the study and then periodically after

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJan 2001
  3. Primary completion5 Aug 2010
  4. Study completion5 Aug 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
1,506 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00052936
Sponsor's protocol ID
CDR0000269015
Other IDs
DSHNHL-1999-1A, EU-20243
Status last verified
May 2021
First submitted
24 Jan 2003
Last updated
18 May 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18226581

  • 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.

    PubMed 39227453

  • 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.

    PubMed 28398499

  • 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.

    PubMed 25403207

  • 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.

    PubMed 25135997

  • Held G, Murawski N, Ziepert M, Fleckenstein J, Poschel V, Zwick C, Bittenbring J, Hanel M, Wilhelm S, Schubert J, Schmitz N, Loffler M, Rube C, Pfreundschuh M. Role of radiotherapy to bulky disease in elderly patients with aggressive B-cell lymphoma. J Clin Oncol. 2014 Apr 10;32(11):1112-8. doi: 10.1200/JCO.2013.51.4505. Epub 2014 Feb 3.

    PubMed 24493716

  • 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.

    PubMed 23335369

  • 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.

    PubMed 22337718

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing filgrastim, rituximab and CHOP regimen in people with Lymphoma, run by German High-Grade Non-Hodgkin's Lymphoma Study Group at 174 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 174 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to treatment failure at 3 years within the study and then periodically after study completion (time frame: 3 years within the study and then periodically after study completion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00052936, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in