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LymphomaPhase 3NCT00053768

Combination Chemotherapy Followed By Radiation Therapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma

A Phase 3 study testing filgrastim, EPOCH regimen and cyclophosphamide in people with Lymphoma, run by German High-Grade Non-Hodgkin's Lymphoma Study Group at 175 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. Combining more than one drug and giving the drugs in different ways may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. 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, EPOCH regimen and cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
392 participants
Where
175 sitesin 2 countries
Study dates
Apr 2002to 5 Dec 2006
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed aggressive non-Hodgkin's lymphoma
  • Previously untreated disease
  • Favorable prognosis
  • International Prognostic Index score of 0-1
  • No more than 25% marrow involvement

PATIENT CHARACTERISTICS:

Age

  • 18 to 60

Performance status

  • ECOG 0-3 OR
  • Karnofsky 40-100%

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

  • No active hepatitis infection

Renal

  • Not specified

Other

  • HIV negative
  • Not pregnant or nursing
  • No relevant accompanying disease
  • No other concurrent malignancy
  • No contraindications to any study medications
  • No prior noncompliance by patient

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy

Surgery

  • Not specified

Other

  • No other concurrent participation in another treatment study

Trial locations and contacts

175 sites in 2 countries.

175 sites in 2 countries

Germany173 sites

  • Haematologisch Onkologische Praxis

    Aachen, 52070

  • Klinikum St. Marien

    Amberg, D-92224

  • Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie

    Ansbach, D-91522

  • Specialist Practice for Oncology

    Aschaffenburg, 63739

  • II. Medizinische Klinik

    Aschaffenburg, D-63739

  • Haematologische Praxis

    Augsburg, 86150

  • Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg

    Augsburg, 86150

  • Klinikum Augsburg

    Augsburg, D-86156

  • Kreiskrankenhaus Aurich

    Aurich, D-26603

  • Kreiskrankenhaus

    Bad Hersfeld, D-36251

  • Humaine - Clinic

    Bad Saarow, D-15526

  • Krankenhaus Hohe Warte Mediziniche Klinik

    Bayreuth, D-95445

  • Onkolog - Haematolog Schwerpunktpraxis

    Berlin, 13357

  • Charite - Campus Charite Mitte

    Berlin, D-13125

  • Hospital Complex Bernburg

    Bernburg, D-06406

  • Krankenhaus Bietigheim

    Bietigheim, D-74319

  • Saint Agnes Hospital

    Bocholt, D-46397

  • Saint Josef Hospital

    Bochum, D-44791

  • Knappschaft Krankenhaus

    Bochum, D-44892

  • Medizinische Poliklinik

    Bonn, D-53111

  • Rheinische Friedrich-Wilhelms-Universitat

    Bonn, D-53113

  • DIAKO Ev. Diakonie Krankenhaus gGmbH

    Bremen, D-28239

  • Medizinische Klinik Am Lukas - Krankenhaus

    Bünde, D-32257

  • General Hospital

    Celle, D-29223

  • Hospital Kuchwald Chemnitz

    Chemnitz, D-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

  • Carl - Thiem - Klinkum Cottbus

    Cottbus, D-03048

  • Klinikum Darmstadt

    Darmstadt, D-64283

  • Saint Johannes Hospital Dortmund

    Dortmund, D-44137

  • Universitatsklinikum Carl Gustav Carus

    Dresden, D-01307

  • St. Johannes Hospital - Medical Klinik II

    Duisburg, D-47166

  • Franz Hospital Dulmen

    Dülmen, D-48249

  • Florence-Nightingale-Krankenhause, Deaconess Kaiserswerth

    Düsseldorf, D-40489

  • Hans - Susemihl - Krankenhaus

    Emden, D-26721

  • Klinikum Erfurt

    Erfurt, 99089

  • St. Antonius Hospital

    Eschweiler, 52249

  • Universitaetsklinikum Essen

    Essen, D-45147

  • Evangelisches Krankenhaus Essen-Werden

    Essen, D-45239

  • Krankenhaus Nordwest

    Frankfurt, 60488

  • Klinikum Frankfurt (Oder) GmbH

    Frankfurt (Oder), 15236

  • Evang. Deaconess Hospital Freiburg

    Freiburg im Breisgau, D-79110

  • Municipal Hospital Complex

    Fulda, 36043

  • Robert - Koch Hospital

    Gehrden, 30989

  • Centre for Internal Medicine Gießen

    Giessen, D-35392

  • Universitaetsklinikum Göttingen

    Göttingen, D-37075

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

    Greifswald, D-17489

  • Staedtisches Klinikum Guetersloh

    Gütersloh, 33332

  • St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

    Hagen, 58095

  • Allgemeines Krankenhaus Hagen

    Hagen, D-58095

  • Krankenhaus St. Elisabeth und St. Barbara

    Halle, 06110

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH

    Halle, 06120

  • Universitaetsklinikum Halle

    Halle, D-06097

  • Study site

    Hamburg, 20095

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, D-20251

  • Asklepios Klinik Nord Heidberg

    Hamburg, D-22413

  • Allgemeines Krankenhaus Altona

    Hamburg, D-22763

  • Haematologisch-Onkologische Praxis Altona

    Hamburg, D-22767

  • Evangelische Krankenhaus Hamm

    Hamm, D-59063

  • Study site

    Hanover, 30159

  • Krankenhaus Siloah - Medizinische Klinik II

    Hanover, 30449

  • Henriettenstiftung Krankenhaus

    Hanover, 30559

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Oncology Specialists Clinic

    Harrislee, D-24955

  • Medizinische Universitaetsklinik und Poliklinik

    Heidelberg, 69115

  • Thoraxklinik Heidelberg

    Heidelberg, D-69126

  • Regional Hospital Heidenheim

    Heidenheim, 89522

  • Regional Hospital Am Plattenwald - Bad Friedrichhall

    Heilbronn, D-74172

  • Klinikum Herford

    Herford, 32049

  • Marienhospital at Ruhr University Bochum

    Herne, 44625

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

    Herrsching am Ammersee, D-82211

  • Onkologische Schwerpunktpraxis

    Hildesheim, 31134

  • Evang. Hospital

    Holzminden, D-37603

  • Medical University Hospital Homburg

    Homburg, 66421

  • Universitaetsklinikum des Saarlandes

    Homburg, D-66424

  • Hospital Complex Hoyerswerda

    Hoyerswerda, D-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, D-76133

  • Red Cross Hospital Kassel

    Kassel, D-34121

  • Staedtisches Krankenhaus Kiel

    Kiel, D-23116

  • Praxis fuer Haematologie und Onkologie

    Koblenz, D-56068

  • Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH

    Koblenz, D-56068

  • Kliniken der Stadt Koeln gGmbH - Krankenhaus Merheim

    Koln-Merheim, D-51109

  • Leonardis Clinic

    Kornwestheim, D-70806

  • Klinikum Krefeld GmbH

    Krefeld, D-47805

  • Frankenwald Klinik

    Kronach, D-96317

  • Caritas - Krakenhaus Lebach

    Lebach, D-66822

  • Medizinische Klinik und Poliklinik III - Universitaetsklinikum Leipzig

    Leipzig, D-04103

  • University Leipzig Clinic of Internal Medicine

    Leipzig, D-04103

  • Study site

    Leipzig, D-04103

  • Staedtisches Klinikum "St. Georg" Leipzig

    Leipzig, D-04129

  • Klinikum Lippe - Lemgo

    Lemgo, D-32657

  • St. Vincenz Hospital Limburg

    Limburg, D-65549

  • St. Bonifatius Hospital Lingen

    Lingen, D-49808

  • Dreifaltigkeits Hospital

    Lippstadt, D-59555

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lübeck, D-23538

  • Klinikum Ludwigsburg

    Ludwigsburg, D-71460

  • Klinikum der Stadt Ludwigshafen am Rhein

    Ludwigshafen, D-67063

  • St. Marien Hospital Ludwighafen

    Ludwigshafen, D-67067

  • Staedtisches Klinikum Magdeburg - Altstadt

    Magdeburg, D-39104

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

    Magdeburg, D-39120

  • Johannes Gutenberg University

    Mainz, D-55131

  • German CML Study Group

    Manheim, D-68305

  • Study site

    Marburg, D-35037

  • Philipps-Universitaet Marburg Klinikum

    Marburg, D-35043

  • Regional Hospital Mayen

    Mayen, D-56727

  • Klinikum Minden

    Minden, D-32423

  • Study site

    Minden, D-32427

  • Ev. Hospital Bethesda

    Monchenglabach, D-41061

  • Hospital Maria-Hilf II

    Mönchengladbach, D-41063

  • Study site

    Monchenglasbach/Rheydt, D-41239

  • Evangelisches Krankenhaus - Mülheim

    Mülheim, D-45466

  • St. Marien Hospital - Muelheim an der Ruhr

    Mülheim, D-45468

  • Kreiskrankenhaus Muenchberg

    Münchberg, D-95213

  • Munich Oncologic Practice at Elisenhof

    München, D-80335

  • Klinikum der Universitaet Muenchen - Innenstadt Campus

    München, D-80336

  • Krankenhaus Muenchen Schwabing

    Munich, D-80804

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377

  • Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster

    Münster, D-48129

  • Regional Hospital Neumarkt

    Neumarkt, D-92318

  • Staedtisches Klinikum Neunkirchen gGmbH

    Neunkirchen, D-66538

  • Lukaskrankenhaus Neuss

    Neuss, D-41464

  • Klinikum Nuernberg - Klinikum Nord

    Nuremberg, D-90340

  • Klinikum Offenburg

    Offenburg, D-77654

  • Hematologische Praxis

    Oldenburg, D-26121

  • Ev. Hospital Oldenburg

    Oldenburg, D-26122

  • Klinikum Oldenburg

    Oldenburg, D-26133

  • Paracelsus - Klinik Osnabrück

    Osnabrück, D-49076

  • Municipal Hospital Complex

    Pforzheim, D-49 7231 9690

  • Klinikum Ernst Von Bergmann

    Potsdam, D-14467

  • Kreiskrankenhaus Radebeul

    Radebeul, D-01445

  • Krankenhaus St. Elisabeth - Ravensburg

    Ravensburg, D-88212

  • Klinikum der Universitaet Regensburg

    Regensburg, D-93042

  • Hematologische Onkologische Praxis

    Regensburg, D-93047

  • Krankenhaus Barmherzige Brueder Regensburg

    Regensburg, D-93049

  • Jakobi Krankenhaus

    Rheine, D-48431

  • Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock

    Rostock, D-18057

  • Klinik und Poliklinik fuer Strahlentherapie - Universitaetsklinikum Rostock

    Rostock, D-18057

  • Study site

    Rostock, D-18257

  • Caritasklinik St. Theresia

    Saarbrücken, D-66113

  • Schwerpunktpraxis fuer Haematologie und Onkologie

    Saarbrücken, D-66113

  • St. Elizabeth-Klinik Saarlouis

    Saarlouis, D-66713

  • Martin - Luther Hospital

    Schleswig, D-24837

  • Deaconess Hospital

    Schwäbisch Hall, D-74523

  • Leopoldina - Krankenhaus

    Schweinfurt, D-97422

  • Evang. Jung-Stilling Hospital

    Siegen, D-57074

  • St. Lukas - Clinic Solingen

    Solingen, D-42697

  • Klinik fuer Onkologie - Katharinenhospital Stuttgart

    Stuttgart, D-70174

  • Diakonie Klinikum Stuttgart

    Stuttgart, D-70176

  • Klinikum Stuttgart - Buergerhospital

    Stuttgart, D-70191

  • Hospital Bad Cannstatt

    Stuttgart, D-70374

  • Robert-Bosch-Krankenhaus

    Stuttgart, D-70376

  • St. Elisabeth Hospital Thuine

    Thuine, D-49832

  • Regional Hospital Traunstein

    Traunstein, D-83278

  • Krankenanstalt Mutterhaus der Borromaerinnen

    Trier, D-54290

  • Study site

    Trier, D-54290

  • Krankenhaus Der Barmherzigen Brueder

    Trier, D-54292

  • Hospital Tutzing

    Tutzing, D-82327

  • Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

    Ulm, D-89081

  • Ev. Hospital Unna

    Unna, D-59403

  • St. Marienhospital - Vechta

    Vechta, D-49377

  • Klinikum Der Stadt Villingen - Schwenningen

    Villingen-Schwenningen, D-78045

  • Regional Hospital Waldbrol

    Waldbröl, D-51545

  • Hospital Wetzler

    Wetzlar, D-35578

  • Deutsche Klinik fuer Diagnostik

    Wiesbaden, D-65191

  • Dr. Horst-Schmidt-Kliniken

    Wiesbaden, D-65199

  • Ev. Hospital Witten-Herdecke

    Witten, D-58455

  • Kliniken St. Antonius

    Wuppertal, D-42283

  • University Wurzburg

    Würzburg, D-97070

  • Municipal Hospital Complex Zwickau

    Zwickau, D-08060

Other trials in Germany

Switzerland2 sites

  • UniversitaetsSpital Zuerich

    Zurich, CH-8091

  • City Hospital Triemli

    Zurich, D-8063

Other trials in Switzerland

About this study

Official title: Randomised Trial Comparing Chemotherapy Mit CHOEP (Cyclophosphamid, Doxorubicin, Vincristin, Etoposid Und Prednison) In 21-Day Intervals In Standard And Escalated Doses In Patients Aged 18-60 Years Of Age With Aggresive Non-Hodgkin-Lymphomas Favourable Prognoses

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different ways may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known which combination chemotherapy regimen followed by radiation therapy is more effective in treating aggressive non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens followed by radiation therapy to compare how well they work in treating patients with aggressive non-Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES:

  • Compare the efficacy of standard-dose vs high-dose cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone followed by radiotherapy, in terms of time to treatment failure, in patients with aggressive non-Hodgkin's lymphoma.
  • Compare the acute and long-term toxic effects of these regimens in these patients.
  • Compare the complete response rate, survival and tumor control, and disease-free survival in patients treated with these regimens.
  • Analyze the time to relapse after radiotherapy in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to LDH levels (no greater than upper limit of normal [ULN] vs greater than ULN), initial bulky disease (yes vs no), stage (I or II vs II or IV), ECOG performance status (0 or 1 vs 2 or 3), and participating center. Patients are randomized to 1 of 2 treatment arms as follows:

  • Arm I (Standard dose): Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; etoposide IV on days 1-3; and oral prednisone on days 1-5 (CHOEP) in standard doses.
  • Arm II (Escalated dose): Patients receive high-dose CHOEP as in arm I. Patients also receive filgrastim (G-CSF) subcutaneously on days 6-12.

In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of CHOEP chemotherapy, patients with initial bulky disease or extranodal involvement undergo radiotherapy 5 days a week for 4 weeks.

Patients who undergo radiotherapy are followed at 2 months after radiotherapy. All patients (including those who undergo radiotherapy) are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 389 patients were 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 mixed cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, stage I adult diffuse mixed cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage IV adult diffuse mixed cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, contiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult Burkitt lymphoma, stage I adult diffuse large cell lymphoma, stage I adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult Burkitt lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult Burkitt lymphoma
Medical subject headings
Lymphoma, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Burkitt Lymphoma, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 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 NCT00053768
Study groupRoleWhat they receive
CHOEP-21Active comparatorCHOEP-21-Schema: Cyclophosphamid (750 mg/m2 i.v. d1), Doxorubicin (50 mg/m2 i.v. d1), Vincristin (2 mg i.v. d1), Etoposid (100 mg/m² i.v. d1-3), Prednison (100 mg p.o. d1-5)
Receives: Biological: filgrastim; Drug: EPOCH regimen; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: prednisone; Drug: vincristine sulfate; Radiation: radiation therapy
high CHOEP-21ExperimentalHigh-CHOEP-21-Schema: Cyclophosphamid (1400 mg/m2 i.v. d1), Doxorubicin (32,5 mg/m2 i.v. d1+2), Vincristin (2 mg i.v. d1), Etoposid (175 mg/m² i.v. d1-3), Prednison (100 mg p.o. d1-5)
Receives: Biological: filgrastim; Drug: EPOCH regimen; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; 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 (TTF) at first relapse

    Time to Treatment failure using the Kaplan_Meier-Method

    Measured: 3 years within study and periodically after study completion

Secondary outcomes (4)

  1. Complete response rate at first relapse

    Number of complete remission (CR) and unconfirmed complete Remission (CRu)

    Measured: 3 years within study and periodically after study completion

  2. Survival time

    Time till death (whatever cause)

    Measured: 3 years within study and periodically after study completion

  3. Tumor control

    Calcution of treatment Duration using the Kaplan-Meier method

    Measured: thought the treatment

  4. Disease-free survival

    Time of disease-free survivial

    Measured: 3 years within study and periodically after study completion

Timeline

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

  1. First posted6 Feb 2003 (estimated)
  2. Study startApr 2002
  3. Primary completion5 Dec 2006
  4. Study completion5 Dec 2006

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
392 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00053768
Sponsor's protocol ID
CDR0000269371
Other IDs
DSHNHL-1999-2, EU-20242
Status last verified
May 2021
First submitted
5 Feb 2003
Last updated
18 May 2021
Results posted
No

Publications

  • Trumper L, Zwick C, Ziepert M, Hohloch K, Schmits R, Mohren M, Liersch R, Bentz M, Graeven U, Wruck U, Hoffmann M, Metzner B, Hasenclever D, Loeffler M, Pfreundschuh M; German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL). Dose-escalated CHOEP for the treatment of young patients with aggressive non-Hodgkin's lymphoma: I. A randomized dose escalation and feasibility study with bi- and tri-weekly regimens. Ann Oncol. 2008 Mar;19(3):538-44. doi: 10.1093/annonc/mdm497. Epub 2008 Jan 22.

    PubMed 18212092

  • Pfreundschuh M, Zwick C, Zeynalova S, Duhrsen U, Pfluger KH, Vrieling T, Mesters R, Mergenthaler HG, Einsele H, Bentz M, Lengfelder E, Trumper L, Rube C, Schmitz N, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL). Dose-escalated CHOEP for the treatment of young patients with aggressive non-Hodgkin's lymphoma: II. Results of the randomized high-CHOEP trial of the German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL). Ann Oncol. 2008 Mar;19(3):545-52. doi: 10.1093/annonc/mdm514. Epub 2007 Dec 6.

    PubMed 18065407

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing filgrastim, EPOCH regimen and cyclophosphamide in people with Lymphoma, run by German High-Grade Non-Hodgkin's Lymphoma Study Group at 175 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 175 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 (TTF) at first relapse (time frame: 3 years within study and 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 NCT00053768, which also lists 2 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.

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