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

May 25, 2016 updated by: Arbeitsgemeinschaft medikamentoese Tumortherapie

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

683

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Concord, Australia
        • Concord Repatriation General Hospital
      • Gosford, Australia
        • Gosford Hospital
      • Greenslopes, Australia
        • Greenslopes Hospital
      • Sidney, Australia
        • Prince of Wales Hospital
    • Victoria
      • Wodonga, Victoria, Australia
        • Border Medical Oncology
  • Austria
      • Bregenz, Austria, A-6900
        • LKH Bregenz
      • Dornbirn, Austria, A-6850
        • KH Dornbirn
      • Fuerstenfeld, Austria, A-8280
        • A.ö. Landeskrankenhaus Fürstenfeld
      • Graz, Austria, A-8036
        • Universitätsklinikum Graz
      • Hohenems, Austria, A-6845
        • LKH Hohenems
      • Innsbruck, Austria, A-6020
        • Universitaetsklinik Innsbruck
      • Klagenfurt, Austria, A-9020
        • Landeskrankenhaus Klagenfurt
      • Leoben, Austria, A-8700
        • A.ö. Landeskrankenhaus Leoben
      • Linz, Austria, A-4020
        • Krankenhaus der Stadt Linz
      • Mistelbach, Austria, A-2130
        • LKH Weinviertel Mistelbach
      • Salzburg, Austria, A-5020
        • St. Johanns LK
      • Vienna, Austria, A-1140
        • Hanusch-Krankenhaus
      • Vienna, Austria, A-1160
        • Wilhelminenspital
      • Vienna, Austria, A-1020
        • KH Barmherzige Brüder
      • Vienna, Austria, A-1030
        • Krankenhaus der Stadt Wien Rudolfsstiftung
      • Vienna, Austria, A-1090
        • AKH Wien / Hämatologie u. Hämostaseologie
      • Vienna, Austria, A-1100
        • Kaiser-Franz-Josef-Spital
      • Vienna, Austria, A-1130
        • Krankenhaus der Stadt Wien Lainz
      • Vienna, Austria, A-1220
        • Sozialmedizinisches Zentrum Ost - Donauspital
      • Villach, Austria, A-9500
        • LKH Villach
      • Voecklabruck, Austria, A-4840
        • LKH Vöcklabruck
      • Waidhofen, Austria, A-3830
        • KH Waidhofen/Thaya
      • Zams, Austria, A-6511
        • BKH Zams
    • Burgenland
      • Oberpullendorf, Burgenland, Austria, A-7350
        • Krankenhaus Oberpullendorf
      • Oberwart, Burgenland, Austria, A-7400
        • Krankenhaus Oberwart
    • Niederoesterreich
      • St. Poelten, Niederoesterreich, Austria, A-3100
        • A.ö. Krankenhaus der Landeshauptstadt St. Pölten
      • Wr. Neustadt, Niederoesterreich, Austria, A-2770
        • A.ö. Krankenhaus der Statutarstadt Wr. Neustadt
    • Oberoesterreich
      • Linz, Oberoesterreich, Austria, A-4010
        • Krankenhaus d. Barmherzigen Schwestern Linz
      • Linz, Oberoesterreich, Austria, A-4010
        • Krankenhaus der Elisabethinen Linz
      • Ried, Oberoesterreich, Austria, A-4910
        • KH Barmherzige Schwestern Ried
    • Oberösterreich
      • Wels, Oberösterreich, Austria, A-4600
        • Klinikum Kreuzschwestern Wels GmbH
    • Steiermark
      • Steyr, Steiermark, Austria, A-4400
        • A.ö. Landeskrankenhaus Steyr
    • Tirol
      • Endach, Tirol, Austria, A-6330
        • Bezirkskrankenhaus Kufstein
      • Hall, Tirol, Austria, A-6060
        • A.oe.Bezirkskrankenhaus Hall
      • Innsbruck, Tirol, Austria, A-6020
        • Universitätsklinik Innsbruck/ Klinik für Innere Medizin
    • Vorarlberg
      • Feldkirch, Vorarlberg, Austria, A-6806
        • Landeskrankenhaus Feldkirch
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina, 71 000
        • Clinical Centre University Sarajevo
      • Tuzla, Bosnia and Herzegovina, 75000
        • University Center Tuzla
  • Brazil
      • Goiania, Brazil
        • Centro Goiano de Oncologia
      • Salvador, Brazil
        • Hospital Santa Izabel
      • Sao Paolo, Brazil
        • Hospital das Clinicas FMUSP
      • Sao Paolo, Brazil
        • Hospital deas Clinical FMUSP
  • Bulgaria
      • Plovdiv, Bulgaria
        • UMHAT "St. George" Plodviv
      • Sofia, Bulgaria
        • Nat. Centre of Hematology and Transfusiology Sofia
      • Varna, Bulgaria
        • MHAT "St. Marina" Varna
  • China
      • Bejing, China
        • Chinese PLA General Hospital
      • Chengdu, China
        • West China Hospital of Sichuan University
      • Harbin, China
        • Harbin Institue
      • Nanjing, China
        • Jiangsu Cancer Hospital
      • Shanghai, China
        • Changhai Hospital
      • Shanghai, China
        • Shanghai Ruijin Hospital
  • Croatia
      • Zagreb, Croatia
        • Clinical Hospital Dubrava
      • Zagreb, Croatia
        • Clinical Hopital Center Zagreb
      • Zagreb, Croatia
        • Clinicall Hospital "Merkur"
  • Czech Republic
      • Boskovice, Czech Republic
        • Nemocnice Boskovice s.r.o.
      • Brno, Czech Republic
        • Faculty hospital Brno
      • Kralove, Czech Republic
        • Univ. Hospital and Med. School Hradec Kralove
      • Novi Jicin, Czech Republic
        • Onkologicke Centrum J.G. Mendela
      • Olomouc, Czech Republic
        • Fakultni nemocnice Olomouc
      • Opava, Czech Republic
        • Hospital Opava
      • Ostrava-Poruba, Czech Republic
        • Fakultni Nemocnice Ostrava
      • Prague, Czech Republic
        • Faculty Hospital Binohrady FNKV
      • Praha, Czech Republic
        • Charles University Hospital
      • Praha, Czech Republic
        • University Hospital Motol
      • Usti nad Labem, Czech Republic
        • RTO MN Usti n. Labem
  • Estonia
      • Tallin, Estonia, 12915
        • North Estonian Regional Hospital
      • Tartu, Estonia, 15014
        • Tartu University Hospital
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Tuen Mun Hospital
  • Israel
      • Beer Sheva, Israel
        • Soroka Medical Centre
      • Haifa, Israel
        • Rambam Medical Centre
      • Petah-Tikva, Israel
        • Rabin Medical Centre
      • Rehovot, Israel
        • Kaplan Medical Centre
  • Latvia
      • Riga, Latvia
        • Riga Hematology Center
  • Macedonia, The Former Yugoslav Republic of
      • Skopje, Macedonia, The Former Yugoslav Republic of
        • Clinical Centre Skopje
  • Malaysia
      • Ampang, Malaysia
        • Hospital Ampang
      • Kuala Lumpur, Malaysia
        • Hospital University Kebangsaan Malaysia
  • Mexico
      • Leon, Mexico
        • ISSSTE Hospital Regional de Leon
      • Mexico City, Mexico
        • Hospital General de México
      • Mexico City, Mexico
        • Hospital Español de Mexico
      • Mexico City, Mexico
        • Instituto National de Cancerologia
      • Monterrey, Mexico
        • Hospital Regional Monterrey, ISSTE
      • Puebla, Mexico
        • ISSSTEP Puebla
  • Peru
      • Arequipa, Peru
        • Hospital Carlso alberto seguin escobedo Arequipa
      • Callao, Peru
        • Hospital Alberto Sabogal sooguren Callao
  • Romania
      • Bucharest, Romania, 22328
        • Coltea Hospital
      • Bucharest, Romania
        • Coltea Hospital
      • Bucharest, Romania
        • University Emergency Center Bucharest
      • Targu Mures, Romania
        • Clinic Judatean de Urgenta Brasov
      • Targu Mures, Romania
        • Emergency County Clinical Hospital
  • Russian Federation
      • Belgorod, Russian Federation, 308007
        • Belgorod Regional Clinical Hospital
      • Moscow, Russian Federation, 115478
        • Moscow Regional Clinical Research Institute
      • Moscow, Russian Federation, 125101
        • Botkin City Clinical Hospital
      • Novgorod, Russian Federation, 603126
        • Novgorod Regional Clinical Hospital
      • St. Petersburg, Russian Federation, 194291
        • Leningrad regional Cliniacal Hospital
      • St. Petersburg, Russian Federation, 197089
        • SPB Pavlov State Medical University
      • Ufa, Russian Federation, 450054
        • Republican Clinic Oncology Dispensary
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Centre of Serbia
      • NIs, Serbia, 18000
        • Clinical Centre Nis
      • Novisad, Serbia, 11000
        • Clinical Centre Novi Sad
      • Sremska Kamenica, Serbia, 21204
        • Institute of Oncology Sremska Kamenica
  • Slovakia
      • Bratislava, Slovakia
        • National Cancer Institut Bratislava
      • Bratislava, Slovakia
        • OUSA Bratislava
      • Kosice, Slovakia
        • Východoslovenský onkolgický ústav
      • Martin, Slovakia
        • Martinská fakultná nemocnima
  • Slovenia
      • Ljubljana, Slovenia, 1100
        • Institut of oncology Ljubljana
  • South Africa
      • Pietremarizburg, South Africa
        • Hopelands Cancer Centre
      • Pretoria, South Africa
        • Wilgers Oncology Centre
  • Sweden
      • Falun, Sweden, 79182
        • Falun hospital
      • Lulea, Sweden, 97180
        • Sunderby Hospital
      • Sundsvall, Sweden, 85186
        • Sundsvall Hospital
      • Uddevalla, Sweden, 45180
        • Uddevalla Hospital
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Hospital
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
      • Taipei, Taiwan
        • Taichung Veterans General Hospital
  • Thailand
      • Bangkok, Thailand
        • Ramathibodi Hospital
      • Bangkok, Thailand
        • King Chulalongkorn Memorial Hospital
      • Bangkok, Thailand
        • Phramongkutklao college of medicine
      • Bangkok, Thailand
        • Siriray Hospital
      • Chiang Mai, Thailand
        • Chiang Mai University
      • Khon kaen, Thailand
        • Srinagarind Hospital
      • Songkla, Thailand
        • Songklanagrarind Hospital
  • Turkey
      • Ankara, Turkey, 06620
        • Ankara University, School of Medicine
      • Eskisehir, Turkey, 26480
        • Osmangazi Univ. school of Medicine
      • Gaziantep, Turkey, 27310
        • Gaziantep University School of Medicine
      • Kayseri, Turkey, 38039
        • Ericyes Univ. Med. School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A
Treatment
Drug: Rituximab
Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)
NO_INTERVENTION: B
Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
event free survival
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
progression free survival, overall survival and safety
Time Frame: four years
four years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Collaborators

Hoffmann-La Roche

Investigators

  • Principal Investigator: Ulrich Jaeger, Prof. Dr., Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

November 16, 2006

First Submitted That Met QC Criteria

November 16, 2006

First Posted (ESTIMATE)

November 17, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 26, 2016

Last Update Submitted That Met QC Criteria

May 25, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHL-13 (ML18223)

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Clinical Study Report

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diffuse Large B-Cell Lymphoma (DLBCL)

Clinical Trials on Rituximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe