AzTrials
AzTrials

LymphomaPhase 3NCT00278408

Rituximab and Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With B-Cell Non-Hodgkin's Lymphoma

A Phase 3 study testing filgrastim, rituximab and cyclophosphamide in people with Lymphoma, run by German High-Grade Non-Hodgkin's Lymphoma Study Group at 152 sites in 4 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: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Lymphoma
What is being tested?
filgrastim, rituximab and cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
152 sitesin 4 countries
Study dates
2 Jan 2006to Feb 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma, including the following subtypes:
  • Grade 3 follicular lymphoma
  • Diffuse B-cell lymphoma, including diffuse large cell lymphoma with the following variants:
  • Centroblastic
  • Immunoblastic
  • Plasmablastic
  • Anaplastic large cell
  • T-cell-rich B-cell lymphoma
  • Primary effusion lymphoma
  • Intravascular B-cell lymphoma
  • Primary mediastinal B-cell lymphoma
  • Burkitt's or Burkitt-like lymphoma
  • Mantle cell lymphoma (blastoid)
  • Aggressive marginal zone lymphoma (monocytoid)
  • Previously untreated disease
  • CD20-positive disease
  • International prognostic index (IPI) score 0 or 1 (age-adjusted)
  • Only patients with bulky disease, as defined by largest single or conglomerate tumor ≥ 7.5 cm in diameter, are allowed to have an IPI score of 0
  • No mucosa-associated lymphoid tissue (MALT) lymphoma
  • No CNS involvement of lymphoma (intracerebral, meningeal, or intraspinal)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Platelet count ≥ 100,000/mm³
  • WBC ≥ 2,500/mm³
  • No known hypersensitivity to the study medications
  • No known HIV-positivity
  • No active hepatitis infection
  • Not pregnant or lactating
  • Negative pregnancy test
  • No other malignancy within the past 5 years except carcinoma in situ or basal cell skin cancer
  • No impaired left ventricular function
  • No severe cardiac arrhythmias
  • No other impaired organ function
  • No other serious disorder

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy
  • No prior immunosuppressive treatment with cytostatics
  • No concurrent participation in other treatment studies

Trial locations and contacts

152 sites in 4 countries.

152 sites in 4 countries

Germany138 sites

  • GMP Tummes/Weinberg

    Aachen

  • Klinikum St. Marien

    Amberg, D-92224

  • Klinikum Augsburg

    Augsburg, DOH-86156

  • Kreiskrankenhaus Aurich

    Aurich, 26603

  • Klinikum Bayreuth

    Bayreuth, D-95445

  • Charite - Campus Charite Mitte

    Berlin, D-10117

  • Charite University Hospital - Campus Virchow Klinikum

    Berlin, D-13353

  • Helios Klinikum Berlin-Buch, Department of Hematology and Stem Cell Transplantation

    Berlin

  • Franziskus Hospital

    Bielefeld, D-33615

  • Augusta-Kranken-Anstalt gGmbH

    Bochum, D-44791

  • Johanniter Krankenhaus Bonn

    Bonn

  • Universitätsklinikum Bonn

    Bonn

  • Staedtisches Klinikum Braunschweig

    Braunschweig, D-38114

  • Klinikum Bremen-Mitte

    Bremen, D-28205

  • Evangelisches Diakonie-Krankenhaus gGmbH, Department of Internal Medicine

    Bremen

  • Praxis Dr. Obst

    Burgwedel

  • Onkologische Schwerpunktpraxis Celle

    Celle, D-29221

  • Hospital Kuchwald Chemnitz - Department of Internal Medicine III

    Chemnitz, 09113

  • Klinikum Chemnitz

    Chemnitz

  • Klinikum Coburg

    Coburg

  • Praxis Fuer Haematologie Internistische Onkologie

    Cologne, D-50677

  • Medizinische Universitaetsklinik I at the University of Cologne

    Cologne, D-50924

  • Gemeinschaftspraxis Dres. Schmitz, Steinmetz, Severin

    Cologne

  • Krankenhaus Holweide

    Cologne

  • Lungenklinik Köln-Merheim

    Cologne

  • Carl - Thiem - Klinkum Cottbus

    Cottbus, D-03048

  • Klinikum Dortmund

    Dortmund, D-44137

  • Virngrund-Klinik Ellwangen

    Ellwangen, 73479

  • Hans - Susemihl - Krankenhaus

    Emden, 26721

  • Universitätsklinikum Erlangen

    Erlangen

  • St. Antonius Hospital

    Eschweiler, DOH-52249

  • Universitaetsklinikum Essen

    Essen, D-45122

  • Klinikum Esslingen

    Esslingen am Neckar

  • Krankenhaus Nordwest

    Frankfurt, D-60488

  • Klinikum der J.W. Goethe Universitaet

    Frankfurt, D-60590

  • Klinikum Frankfurt (Oder) GmbH

    Frankfurt (Oder), D-15236

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, D-79106

  • GMP Dres. Marschner, Zaiss, Kirste, Semsek

    Freiburg im Breisgau

  • Praxis Dr. med. Reiber

    Freiburg im Breisgau

  • Klinikum Fulda

    Fulda

  • Klinikum Garmisch - Partenkirchen GmbH

    Garmisch-Partenkirchen, D-82467

  • Saint Josef Hospital

    Gelsenkirchen, D-45899

  • Praxis Dr. med. Schliesser

    Giessen

  • Wilhelm-Anton-Hospital gGmbH, Goch

    Goch, D-47574

  • Universitaetsklinikum Goettingen, Department of Hematology and Oncology

    Göttingen, D-37075

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

    Greifswald, D-17475

  • Gemeinschaftspraxis

    Güstrow

  • St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

    Hagen, D-58095

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH

    Halle, D-06120

  • GMP Rohrberg, Hurtz, Schmidt, Frank-Gleich

    Halle

  • Asklepios Klinik St. Georg

    Hamburg, D-20099

  • University Medical Center Hamburg - Eppendorf

    Hamburg, D-20246

  • Hämatologisch-onkologische Praxis Altona (HOPA)

    Hamburg

  • Evangelisches Krankenhaus Hamm

    Hamm

  • Klinikum Stadt Hanau

    Hanau, 63450

  • Krankenhaus Siloah - Medizinische Klinik II

    Hanover, D-30449

  • Medizinische Hochschule Hannover

    Hanover, D-30625

  • Medizinische Universitaetsklinik und Poliklinik

    Heidelberg, 69115

  • Klinikum Kreis Herford

    Herford

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

    Herrsching am Ammersee, D-82211

  • St. Bernward Krankenhaus

    Hildesheim, D-31134

  • Evangelisches Krankenhaus Holzminden

    Holzminden

  • Haematologie und Internistische Onkologie Praxis

    Homberg (Efze), D-34576

  • Universitaetsklinikum des Saarlandes

    Homburg, D-66424

  • Clinic for Bone Marrow Transplantation and Hematology and Oncology

    Idar-Oberstein, D-55743

  • Staedtisches Klinikum Karlsruhe gGmbH

    Karlsruhe, 76133

  • St. Vincentius Kliniken Karlsruhe

    Karlsruhe

  • Internistische Gemeinschaftspraxis - Kassel

    Kassel, D-34117

  • Klinikum Kempten Oberallgaeu

    Kempten, D-87439

  • Staedtisches Krankenhaus Kiel

    Kiel, 23116

  • University Hospital Schleswig-Holstein - Kiel Campus

    Kiel, D-24116

  • Gemeinschaftspraxis Dres. Heymanns, Weide, Thomalla

    Koblenz

  • Praxis Dr. Stauch

    Kronach

  • Internistische Praxis - Landshut

    Landshut, 84028

  • Klinikum Landshut

    Landshut

  • Caritas Krankenhaus Lebach

    Lebach

  • Onkologische Schwerpunktpraxis Dr. Lothar Müller

    Leer

  • Klinikum St. Georg Leipzig

    Leipzig

  • Onkologische Praxis am Diakonissenhaus

    Leipzig

  • Klinikum Lippe-Lemgo

    Lemgo

  • Universitätsklinikum Schleswig-Holstein

    Lübeck

  • Kreiskrankenhaus Luedenscheid

    Lüdenscheid, 58515

  • St. Marienkrankenhaus

    Ludwigshafen

  • Klinikum der Stadt Ludwigshafen am Rhein

    Ludwigshafen am Rhein, D-67063

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

    Magdeburg, D-39120

  • Krankenhaus Altstadt Magdeburg

    Magdeburg

  • III Medizinische Klinik Mannheim

    Mannheim, D-68305

  • Mannheimer Onkologie Praxis

    Mannheim

  • Universitätsklinikum Gießen und Marburg (UKGM)

    Marburg

  • Klinikum Minden

    Minden, D-32423

  • Krankenhaus Maria Hilf GmbH

    Mönchengladbach, D-41063

  • Gemeinschaftspraxis Dres. Schröder, Sieg

    Mülheim

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377

  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen

    Munich, D-81675

  • Gemeinschaftspraxis Abenhardt, Bojko, Bosse, Riedner

    Munich

  • Städtisches Klinikum München Harlaching

    Munich

  • Haematologisch - Onkologische Gemeinschaftspraxis - Muenster

    Münster, D-48149

  • Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster

    Münster, D-48149

  • Stauferklinikum Schwäbisch Gmünd

    Mutlangen

  • Onkologische Schwerwpunktpraxis Dr. Ladda

    Neumarkt, D-92318

  • Lukaskrankenhaus Neuss

    Neuss

  • BRK Schloßbergklinik Oberstaufen

    Oberstaufen

  • GMP Dres. Balló, Böck

    Offenbach

  • Klinikum Oldenburg - Department of Hematology and Oncology

    Oldenburg, D-26133

  • Pius Hospital Oldenburg, Department of Internal Oncology

    Oldenburg

  • Paracelsus Krankenhaus Ruit

    Ostfildern

  • Bruederkrankenhaus St. Josef Paderborn

    Paderborn, D-33098

  • Krankenhaus Siloah

    Pforzheim

  • Praxis Dr. Dencausse

    Pforzheim

  • Klinikum der Universitaet Regensburg

    Regensburg, D-93053

  • Krankenhaus Barmherzige Brüder Regensburg

    Regensburg

  • Klinikum am Steinenberg

    Reutlingen

  • Klinikum Suedstadt Rostock

    Rostock, D-18059

  • Universitätsklinikum Rostock

    Rostock

  • Gemeinschaftspraxis Dres. Jacobs, Daus, Schmits

    Saarbrücken

  • Leopoldina - Krankenhaus

    Schweinfurt, D-97422

  • St. Marien - Krankenhaus Siegen GMBH

    Siegen, D-57072

  • Onkologische Schwerpunktpraxis - Straubing

    Straubing, 94315

  • Klinik fuer Onkologie - Katharinenhospital Stuttgart

    Stuttgart, D-70174

  • Diakonie Klinikum Stuttgart

    Stuttgart, D-70176

  • Bürgerhospital

    Stuttgart

  • Krankenanstalt Mutterhaus der Borromaerinnen

    Trier, D-54219

  • Krankenhaus Der Barmherzigen Brueder

    Trier, D-54292

  • Praxis Fuer Internistische Haematologie / Onkologie

    Troisdorf, 53840

  • Universitätsklinikum Tübingen, Department of Internal Medicine II

    Tübingen

  • Praxis fuer Haematologie und Onkologie

    Twistringen, D-27239

  • Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

    Ulm, D-89081

  • Katharinen Hospital Unna

    Unna

  • St. Marienhospital - Vechta

    Vechta, D-49377

  • Praxis VS-Villingen

    Villingen-Schwenningen

  • Regional Hospital Waldbrol

    Waldbröl, D-51545

  • Med. Versorgungszentrum Weiden

    Weiden

  • Harz-Klinikum-Wernigerode

    Wernigerode

  • Ammerland Klinik GmbH Westerstede

    Westerstede

  • Dr. Horst-Schmidt-Kliniken

    Wiesbaden, D-65199

  • Kliniken St. Antonius

    Wuppertal, D-42283

  • Helios Klinikum Wuppertal

    Wuppertal

  • Heinrich-Braun-Krankenhaus Zwickau

    Zwickau, 08060

Other trials in Germany

Italy11 sites

  • Ospidale A. Cardarelli

    Campobasso

  • Azienda Ospedaliera di Cosenza

    Cosenza

  • AOU San Martino Genova

    Genova

  • Az. Ospedaliera Messina

    Messina

  • Policlinico Universitario "G. Martino" Messina

    Messina

  • Centro Oncologico Modenese, University of Modena and Reggio Emilia

    Modena

  • Ematologia - OSP. Civile Piacenza

    Piacenza

  • A. Santa Maria Nuova, Hematology Azienda

    Reggio Emilia

  • Osp. S. Vincenzo - Taormina

    Taormina

  • Ospedale San Giuseppe Moscati

    Taranto

  • Ospedale di circolo e Fondazione Macchi Varese

    Varese

Other trials in Italy

Denmark2 sites

  • Rigshospitalet, Department of Hematology

    Copenhagen

  • Amtssygehuset i Herlev

    Herlev

Other trials in Denmark

Israel1 site

  • Rabin Medical Center - Beilinson Campus

    Petah Tikva, 49100

Other trials in Israel

About this study

Official title: Randomized Study Comparing an Immuno-Chemotherapy With 6 Cycles of the Monoclonal Anti-CD20 Antibody Rituximab in Combination With 6 Cycles of Chemotherapy With CHOP ( Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) at 21-day Intervals or 14-day Intervals, Both With or Without Consolidating Radiotherapy or Large Tumour Masses (≥7.5 cm) and/or Extranodal Involvement in Patients With Aggressive CD20 B-Cell Lymphoma Aged 18 to 60 Years With Age-Adjusted IPI=1 (All) or IPI=0 With a Large Tumour Mass (≥7.5 cm) [UNFOLDER 21/14 Study]

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving rituximab and combination chemotherapy together with radiation therapy may kill more cancer cells. It is not yet known which schedule of rituximab and combination chemotherapy is more effective when given with or without radiation therapy in treating non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and combination chemotherapy with or without radiation therapy to compare how well they work in treating patients with aggressive B-cell non-Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the time to treatment failure in patients with previously untreated, low-risk, aggressive, B-cell non-Hodgkin's lymphoma treated with 2 different schedules of immunochemotherapy comprising rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone with vs without radiotherapy.

Secondary

  • Compare the time to progression in patients treated with these regimens.
  • Compare the overall and disease-free/relapse-free survival of patients treated with these regimens.
  • Compare the complete response rate in patients treated with these regimens.
  • Compare the tumor control in patients treated with these regimens.
  • Compare the safety of these regimens in these patients.
  • Compare the pharmacoeconomics of these regimens.
  • Compare patient adherence to these regimens.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to study center, serum lactic dehydrogenase level (≤ upper limit of normal [ULN] vs > ULN), disease stage (I or II vs III or IV), ECOG performance status (0-1 vs 2-3), bulky disease, and extranodal involvement. Patients with initial bulky disease and/or qualifying extranodal involvement are randomized to 1 of 4 treatment arms. Patients with non-bulky disease are randomized to treatment arms I or III.

All patients will be given the option of receiving a 1-week course of pretreatment therapy comprising vincristine IV once on day -6 and oral prednisone once daily on days -6 to 0.

  • Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II (R-CHOP-21 and radiotherapy): Patients receive R-CHOP as in arm I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-6 weeks after the last course of R-CHOP, patients who achieve a complete remission (CR) undergo radiotherapy 5 days a week for approximately 5½ weeks.
  • Arm III (R-CHOP-14): Patients receive R-CHOP as in arm I. Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 4-13 or until blood counts recover. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm IV (R-CHOP-14 and radiotherapy): Patients receive R-CHOP as in arm I. Patients also receive G-CSF an in arm III. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-6 weeks after the last course of R-CHOP, patients who achieve CR undergo radiotherapy as in arm II.

Patients in all arms undergo restaging of their disease after courses 3 and 6 of R-CHOP. Patients with stable disease after 6 courses or disease progression after courses 3 or 6 proceed to salvage chemotherapy off study. Patients achieving a partial remission or an unconfirmed CR after 6 courses undergo additional restaging 4 weeks later. Patients with disease progression proceed to salvage chemotherapy off study. Patients who achieve CR after 6 courses of R-CHOP or have a confirmed CR after the additional restaging undergo radiotherapy according to randomization (as above).

After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,072 patients will be accrued for this study.

Conditions
Lymphoma
Keywords
contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, stage I grade 3 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 3 follicular lymphoma, contiguous stage II adult diffuse large cell lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult diffuse mixed cell lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, nodal marginal zone B-cell lymphoma, anaplastic large cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, stage I adult immunoblastic large cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Large-Cell, Immunoblastic, Burkitt Lymphoma

What participants receive

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

Study groups in NCT00278408
Study groupRoleWhat they receive
Interventional: 6 R-CHOP-21Active comparatorArm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: rituximab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisone; Drug: vincristine sulfate
Interventional: 6 R-CHOP-21 + radiotherapyActive comparatorArm II (R-CHOP-21 and radiotherapy): Patients receive R-CHOP as in arm I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-6 weeks after the last course of R-CHOP, patients who achieve a complete remission (CR) undergo radiotherapy 5 days a week for approximately 5½ weeks.
Receives: Biological: rituximab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisone; Drug: vincristine sulfate; Radiation: radiation therapy
Interventional: 6 R-CHOP-14Active comparatorArm III (R-CHOP-14): Patients receive R-CHOP as in arm I. Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 4-13 or until blood counts recover. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: filgrastim; Biological: rituximab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisone; Drug: vincristine sulfate
Interventional: 6 R-CHOP-14 and radiotherapyActive comparatorArm IV (R-CHOP-14 and radiotherapy): Patients receive R-CHOP as in arm I. Patients also receive G-CSF an in arm III. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-6 weeks after the last course of R-CHOP, patients who achieve CR undergo radiotherapy as in arm II.
Receives: Biological: filgrastim; Biological: rituximab; 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. 3 Years Event-free Survival

    Event-free survival was the primary endpoint, which was defined as the time from randomization until one of the following events had occurred: progression during therapy, partial response, no change, unknown status at the end of study therapy, relapse after complete response or unconfirmed complete response, death from any cause; or additional treatment, whichever came first.

    Measured: Each patient will be observed for 3 years starting from completion of treatment.

Secondary outcomes (9)

  1. 3 Years Progression-free Survival

    Progression of disease is defined as: recurrence of disease symptoms, development of new lymphatic or extralymphatic lesions or marked increase in lymphoma manifestation size by more than 25% in comparison with baseline.

    Measured: Each patient will be observed for 3 years starting from completion of treatment.

  2. 3 Years Overall Survival

    Overall survival was defined as the time from randomization to death of any cause.

    Measured: Each patient will be observed for 3 years starting from completion of treatment.

  3. Rate of Complete Remissions and Progressive Disease

    Measured: Each patient will be observed for 3 years starting from completion of treatment.

  4. Number of Patients With a Relapse After a CR/CRu

    Relapse is defined as, recurrence of disease symptoms, development of new lymphatic or extralymphatic lesions or a marked increase in lymphoma manifestation size by more thyn 25% after at least 2 months CR or CRu from the time point of the final restaging examination

    Measured: Each patient will be observed for 3 years starting from completion of treatment.

  5. Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin)

    Measured: Each patient will be observed for 3 years starting from completion of treatment.

  6. Adherence to Protocol - Absolute Dose Vincristine and Prednisone in mg (Median)

    Measured: Each patient will be observed for 3 years starting from completion of treatment.

  7. Health-economic Aspects - Number of Patients Who Received Antibiotic Intervention and/or Red Blood Cell and Platelet Transfusion

    Measured: Each patient will be observed for 3 years starting from completion of treatment.

  8. Adherence to Protocol - Total Duration of Chemotherapy in Days (Median)

    Measured: Each patient will be observed for 3 years starting from completion of treatment.

  9. Adherence to Protocol - Absolute Dose Cyclophosphamide, Doxorubicin and Rituximab in mg/m² (Median)

    Measured: Each patient will be observed for 3 years starting from completion of treatment.

Timeline

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

  1. First posted18 Jan 2006 (estimated)
  2. Study start2 Jan 2006
  3. Primary completionFeb 2018
  4. Study completionFeb 2018

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
Parallel groups
Masking
None (open label)
Enrolment
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00278408
Sponsor's protocol ID
CDR0000459796
Other IDs
DSHNHL-2004-3, EUDRACT-2005-005218-19, EU-205111
Status last verified
May 2025
First submitted
16 Jan 2006
Last updated
26 Aug 2025
Data monitoring committee
No

Publications

  • Radiotherapy (RT) to bulky (B) and extralymphatic (E) disease in combination with 6xR-CHOP-14 or R-CHOP-21 in young good-prognosis DLBCL patients: Results of the 2x2 randomized UNFOLDER trial of the DSHNHL/GLA. Michael Pfreundschuh, Niels Murawski, Marita Ziepert, Bettina Altmann, Martin H. Dreyling, Peter Borchmann, Stefano Luminari, Mathias Witzens-Harig, Judith Dierlamm, Mathias Haenel, Lorenz Truemper, Bernd Metzner, Eva Lengfelder, Ulrich B. Keller, Christian Ruebe, Christian Berdel, Norbert Schmitz, Gerhard Held, and Viola Poeschel Journal of Clinical Oncology 2018 36:15_suppl, 7574-7574

  • Role of radiotherapy and dose-densification of R-CHOP in primary mediastinal B-cell lymphoma: A subgroup analysis of the unfolder trial of the German Lymphoma Alliance (GLA). Gerhard Held, Lorenz Thurner, Viola Poeschel, Christian Berdel, German Ott, Christian Schmidt, Andreas Viardot, Peter Borchmann, Ofer Shpilberg, Maike Nickelsen, Massimo Federico, Peter de Nully Brown, Niels Murawski, Lorenz H. Trumper, Heinz Schmidberger, Christian Ruebe, Jochen Fleckenstein, Norbert Schmitz, Markus Loeffler, Marita Ziepert, and German Lymphoma Alliance Journal of Clinical Oncology 2020 38:15_suppl, 8041-8041

  • Thurner L, Ziepert M, Berdel C, Schmidt C, Borchmann P, Kaddu-Mulindwa D, Viardot A, Witzens-Harig M, Dierlamm J, Haenel M, Metzner B, Wulf G, Lengfelder E, Keller UB, Frickhofen N, Nickelsen M, Gaska T, Griesinger F, Mahlberg R, Marks R, Shpilberg O, Lindemann HW, Soekler M, Fischer von Weikersthal L, Kiehl M, Roemer E, Bentz M, Krammer-Steiner B, Trappe R, de Nully Brown P, Federico M, Merli F, Engelhard M, Glass B, Schmitz N, Truemper L, Bewarder M, Hartmann F, Murawski N, Stilgenbauer S, Rosenwald A, Altmann B, Schmidberger H, Fleckenstein J, Loeffler M, Poeschel V, Held G. Radiation and Dose-densification of R-CHOP in Aggressive B-cell Lymphoma With Intermediate Prognosis: The UNFOLDER Study. Hemasphere. 2023 Jul 5;7(7):e904. doi: 10.1097/HS9.0000000000000904. eCollection 2023 Jul.

    PubMed 37427146

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing filgrastim, rituximab and cyclophosphamide in people with Lymphoma, run by German High-Grade Non-Hodgkin's Lymphoma Study Group at 152 sites in 4 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 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 152 sites in Germany, Italy, Denmark, Israel. 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?

Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

3 Years Event-free Survival (time frame: Each patient will be observed for 3 years starting from completion of treatment.). 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 NCT00278408, which also lists 3 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 26 Aug 2025.

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