AzTrials
AzTrials

Diffuse Large B-Cell Lymphoma (DLBCL)Phase 3NCT00400478

A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13

A Phase 3 study testing Rituximab in people with Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular NHL Grade 3b, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 131 sites in 26 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

This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL. Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
683 participants
Where
131 sitesin 26 countries
Study dates
Jan 2006to Mar 2013
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 4 to 8 cycles R-CHOP/like, total of 8x Rituximab
  • CR, CRu
  • ECOG/ 0.1 or 2
  • Known IPI at time of diagnosis
  • Age > 18 years
  • Negative pregnancy test
  • Men must agree not to father a child during the therapy

Who cannot join

  • Transformed lymphoma
  • Secondary malignancy
  • Evidence of CNS - involvement
  • Significant cardiac disease
  • Creatinine > 2.0 mg/dl
  • HIV, Hepatitis positive

Trial locations and contacts

131 sites in 26 countries.

131 sites in 26 countries

Austria36 sites

  • LKH Bregenz

    Bregenz, A-6900

  • KH Dornbirn

    Dornbirn, A-6850

  • Bezirkskrankenhaus Kufstein

    Endach, Tyrol, A-6330

  • Landeskrankenhaus Feldkirch

    Feldkirch, Vorarlberg, A-6806

  • A.ö. Landeskrankenhaus Fürstenfeld

    Fürstenfeld, A-8280

  • Universitätsklinikum Graz

    Graz, A-8036

  • A.oe.Bezirkskrankenhaus Hall

    Hall in Tirol, Tyrol, A-6060

  • LKH Hohenems

    Hohenems, A-6845

  • Universitätsklinik Innsbruck/ Klinik für Innere Medizin

    Innsbruck, Tyrol, A-6020

  • Universitaetsklinik Innsbruck

    Innsbruck, A-6020

  • Landeskrankenhaus Klagenfurt

    Klagenfurt, A-9020

  • A.ö. Landeskrankenhaus Leoben

    Leoben, A-8700

  • Krankenhaus d. Barmherzigen Schwestern Linz

    Linz, Upper Austria, A-4010

  • Krankenhaus der Elisabethinen Linz

    Linz, Upper Austria, A-4010

  • Krankenhaus der Stadt Linz

    Linz, A-4020

  • LKH Weinviertel Mistelbach

    Mistelbach, A-2130

  • Krankenhaus Oberpullendorf

    Oberpullendorf, Burgenland, A-7350

  • Krankenhaus Oberwart

    Oberwart, Burgenland, A-7400

  • KH Barmherzige Schwestern Ried

    Ried, Upper Austria, A-4910

  • St. Johanns LK

    Salzburg, State of Salzburg, A-5020

  • A.ö. Krankenhaus der Landeshauptstadt St. Pölten

    Sankt Pölten, Lower Austria, A-3100

  • A.ö. Landeskrankenhaus Steyr

    Steyr, Styria, A-4400

  • KH Barmherzige Brüder

    Vienna, State of Vienna, A-1020

  • Krankenhaus der Stadt Wien Rudolfsstiftung

    Vienna, State of Vienna, A-1030

  • AKH Wien / Hämatologie u. Hämostaseologie

    Vienna, State of Vienna, A-1090

  • Kaiser-Franz-Josef-Spital

    Vienna, State of Vienna, A-1100

  • Krankenhaus der Stadt Wien Lainz

    Vienna, State of Vienna, A-1130

  • Hanusch-Krankenhaus

    Vienna, State of Vienna, A-1140

  • Wilhelminenspital

    Vienna, State of Vienna, A-1160

  • Sozialmedizinisches Zentrum Ost - Donauspital

    Vienna, State of Vienna, A-1220

  • LKH Villach

    Villach, A-9500

  • LKH Vöcklabruck

    Vöcklabruck, A-4840

  • KH Waidhofen/Thaya

    Waidhofen an der Thaya, A-3830

  • Klinikum Kreuzschwestern Wels GmbH

    Wels, Upper Austria, A-4600

  • A.ö. Krankenhaus der Statutarstadt Wr. Neustadt

    Wiener Neustadt, Lower Austria, A-2770

  • BKH Zams

    Zams, A-6511

Other trials in Austria

Czechia11 sites

  • Nemocnice Boskovice s.r.o.

    Boskovice

  • Faculty Hospital Brno

    Brno

  • Univ. Hospital and Med. School Hradec Kralove

    Kralove

  • Onkologické Centrum J.G. Mendela

    Novi Jicin

  • Fakultni Nemocnice Olomouc

    Olomouc

  • Hospital Opava

    Opava

  • Fakultni nemocnice Ostrava

    Ostrava-Poruba

  • Charles University Hospital

    Prague

  • Faculty Hospital Binohrady FNKV

    Prague

  • University Hospital Motol

    Prague

  • RTO MN Usti n. Labem

    Ústí nad Labem

Other trials in Czechia

Russia7 sites

  • Belgorod regional Clinical Hospital

    Belgorod, 308007

  • Moscow Regional Clinical Research Institute

    Moscow, 115478

  • Botkin City Clinical Hospital

    Moscow, 125101

  • Leningrad regional Cliniacal Hospital

    Saint Petersburg, 194291

  • SPB Pavlov State Medical University

    Saint Petersburg, 197089

  • Republican Clinic Oncology Dispensary

    Ufa, 450054

  • Novgorod Regional Clinical Hospital

    Velikiy Novgorod, 603126

Other trials in Russia

Thailand7 sites

  • King Chulalongkorn Memorial Hospital

    Bangkok

  • Phramongkutklao College of Medicine

    Bangkok

  • Ramathibodi Hospital

    Bangkok

  • Siriray Hospital

    Bangkok

  • Chiang Mai University

    Chiang Mai

  • Srinagarind Hospital

    Khon Kaen

  • Songklanagrarind Hospital

    Songkhla

Other trials in Thailand

China6 sites

  • Chinese PLA General hospital

    Beijing

  • West China Hospital of Sichuan University

    Chengdu

  • Harbin Institue

    Harbin

  • Jiangsu Cancer Hospital

    Nanjing

  • Changhai Hospital

    Shanghai

  • Shanghai Ruijin Hospital

    Shanghai

Other trials in China

Mexico6 sites

  • ISSSTE Hospital Regional de Leon

    León

  • Hospital Espanol de Mexico

    Mexico City

  • Hospital General de Mexico

    Mexico City

  • Instituto National de Cancerologia

    Mexico City

  • Hospital Regional Monterrey, ISSTE

    Monterrey

  • ISSSTEP Puebla

    Puebla City

Other trials in Mexico

Australia5 sites

  • Concord Repatriation General Hospital

    Concord

  • Gosford Hospital

    Gosford

  • Greenslopes Hospital

    Greenslopes

  • Prince of Wales Hospital

    Sydney

  • Border Medical Oncology

    Wodonga, Victoria

Other trials in Australia

Romania5 sites

  • Coltea Hospital

    Bucharest, 22328

  • Coltea Hospital

    Bucharest

  • University Emergency Center Bucharest

    Bucharest

  • Clinic Judatean de Urgenta Brasov

    Târgu Mureş

  • Emergency County Clinical Hospital

    Târgu Mureş

Other trials in Romania

Brazil4 sites

  • Centro Goiano de Oncologia

    Goiânia

  • Hospital Santa Izabel

    Salvador

  • Hospital das Clinicas FMUSP

    São Paulo

  • Hospital deas Clinical FMUSP

    São Paulo

Other trials in Brazil

Israel4 sites

  • Soroka Medical Centre

    Beersheba

  • Rambam Medical Centre

    Haifa

  • Rabin Medical Centre

    Petah Tikva

  • Kaplan Medical Centre

    Rehovot

Other trials in Israel

Serbia4 sites

  • Clinical centre of Serbia

    Belgrade, Belgrade, 11000

  • Institute of Oncology Sremska Kamenica

    Kamenitz, 21204

  • Clinical Centre Nis

    Niš, 18000

  • Clinical Centre Novi Sad

    Novisad, 11000

Other trials in Serbia

Slovakia4 sites

  • National Cancer Institut Bratislava

    Bratislava

  • OUSA Bratislava

    Bratislava

  • Východoslovenský onkolgický ústav

    Košice

  • Martinská fakultná nemocnima

    Martin

Other trials in Slovakia

Sweden4 sites

  • Falun Hospital

    Falun, 79182

  • Sunderby Hospital

    Luleå, 97180

  • Sundsvall Hospital

    Sundsvall, 85186

  • Uddevalla Hospital

    Uddevalla, 45180

Other trials in Sweden

Turkey (Türkiye)4 sites

  • Ankara University, School of Medicine

    Ankara, 06620

  • Osmangazi Univ. school of Medicine

    Eskişehir, 26480

  • Gaziantep University School of Medicine

    Gaziantep, 27310

  • Ericyes Univ. Med. School

    Kayseri, 38039

Other trials in Turkey (Türkiye)

Bulgaria3 sites

  • UMHAT "St. George" Plodviv

    Plovdiv

  • Nat. Centre of Hematology and Transfusiology Sofia

    Sofia

  • MHAT "St. Marina" Varna

    Varna

Other trials in Bulgaria

Croatia3 sites

  • Clinical Hopital Center Zagreb

    Zagreb

  • Clinical Hospital Dubrava

    Zagreb

  • Clinicall Hospital "Merkur"

    Zagreb

Other trials in Croatia

Taiwan3 sites

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 807

  • Taipei Veterans General Hospital

    Taipei, 112

  • Taichung Veterans General Hospital

    Taipei

Other trials in Taiwan

Bosnia and Herzegovina2 sites

  • Clinical Centre University Sarajevo

    Sarajevo, 71 000

  • University Center Tuzla

    Tuzla, 75000

Other trials in Bosnia and Herzegovina

Estonia2 sites

  • North Estonian Regional Hospital

    Tallinn, 12915

  • Tartu University Hospital

    Tartu, 15014

Other trials in Estonia

Hong Kong2 sites

  • Queen Mary Hospital

    Hong Kong

  • Tuen Mun Hospital

    Hong Kong

Other trials in Hong Kong

Malaysia2 sites

  • Hospital Ampang

    Ampang

  • Hospital University Kebangsaan Malaysia

    Kuala Lumpur

Other trials in Malaysia

Peru2 sites

  • Hospital Carlso alberto seguin escobedo Arequipa

    Arequipa

  • Hospital Alberto Sabogal sooguren Callao

    Callao

Other trials in Peru

South Africa2 sites

  • Hopelands Cancer Centre

    Pietremarizburg

  • Wilgers Oncology Centre

    Pretoria

Other trials in South Africa

Latvia1 site

  • Riga Hematology Center

    Riga

Other trials in Latvia

North Macedonia1 site

  • Clinical Centre Skopje

    Skopje

Other trials in North Macedonia

Slovenia1 site

  • Institut of Oncology Ljubljana

    Ljubljana, 1100

Other trials in Slovenia

About this study

Official title: A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Aggressive B-cell Lymphoma: NHL-13

This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL.

Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm) will be recruited.

Being tested
Rituximab
Keywords
DLBCL, NHL 13, Rituximab, maintenance
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • RituximabDrug

    Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)

Study groups in NCT00400478
Study groupRoleWhat they receive
AActive comparatorTreatment
Receives: Drug: Rituximab
BNo interventionObservation

What is being measured

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

  1. event free survival

    Measured: 4 years

Secondary outcomes (1)

  1. progression free survival, overall survival and safety

    Measured: four years

Timeline

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

  1. First posted17 Nov 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionMar 2013
  4. Study completionMar 2013

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
683 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00400478
Sponsor's protocol ID
NHL-13 (ML18223)
Status last verified
May 2016
First submitted
16 Nov 2006
Last updated
26 May 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Jaeger U, Trneny M, Melzer H, Praxmarer M, Nawarawong W, Ben Yehuda D, Goldstein D, Mihaljevic B, Ilhan O, Ballova V, Hedenus M, Hsiao LT, Au WY, Burgstaller S, Weidinger G, Keil F, Dittrich C, Skrabs C, Klingler A, Chott A, Fridrik MA, Greil R; AGMT-NHL13 Investigators. Rituximab maintenance for patients with aggressive B-cell lymphoma in first remission: results of the randomized NHL13 trial. Haematologica. 2015 Jul;100(7):955-63. doi: 10.3324/haematol.2015.125344. Epub 2015 Apr 24.

    PubMed 25911553

  • Jaeger U, Praxmarer M, Greil R; AGMT-NHL13 investigators. Response to comment by P. Vassilakopoulos and colleagues. Haematologica. 2015 Nov;100(11):e482. doi: 10.3324/haematol.2015.134288. No abstract available.

    PubMed 26521299

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab in people with Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular NHL Grade 3b, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 131 sites in 26 countries.

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

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. 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 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 131 sites in Austria, Czechia, Russia, Thailand, China and 21 more countries. 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?

event free survival (time frame: 4 years). 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 NCT00400478, 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 26 May 2016.

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