AzTrials
AzTrials

LymphomaPhase 3NCT00004179

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

A Phase 3 study testing rituximab, CHOP regimen and cyclophosphamide in people with Lymphoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 261 sites in 18 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 cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Lymphoma
What is being tested?
rituximab, CHOP regimen and cyclophosphamide
How many people
475 participants
Where
261 sitesin 18 countries
Study dates
May 1999to 19 Jul 2017
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 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically proven stage III or IV follicular non-Hodgkin's lymphoma (NHL)
  • Relapsed after or no response (no change/progressive disease) to no more than 2 adequate non-anthracycline-containing systemic chemotherapy regimens
  • At least 2 months of single-agent therapy (e.g., chlorambucil) AND/OR
  • At least 2 consecutive courses of polychemotherapy (e.g., cyclophosphamide, vincristine, and prednisone) or purine analogues
  • Complete or partial remission or no change for at least 4 weeks after completion of prior therapy OR progression during one of a maximum of 2 prior therapy regimens
  • CD20 positive
  • At least 1 bidimensionally measurable mass
  • No greater than 10,000,000/mL circulating tumor cells
  • IgG levels at least 3 g/L
  • No low-grade NHL transformed into intermediate- or high-grade NHL
  • No symptomatic CNS lymphoma
  • No bone marrow involvement only NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin less than 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 2.5 times ULN

Renal:

  • Creatinine less than 2.5 times ULN
  • BUN less than 2.5 times ULN

Cardiovascular:

  • No severe cardiac disease (i.e., severe heart failure requiring symptomatic treatment)

Pulmonary:

  • No severe pulmonary disease

Other:

  • No severe neurologic or psychiatric disease
  • No severe metabolic disease
  • Not pregnant
  • Fertile patients must use effective contraception
  • No prior malignancy within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of the cervix, or other cancer curatively treated with surgical therapy
  • HIV negative
  • No uncontrolled asthma or allergy requiring steroids
  • No known hypersensitivity or prior anaphylactic reaction to murine proteins or any component of study drug

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior rituximab
  • No prior allogeneic or autologous peripheral blood stem cell transplantation
  • Concurrent filgrastim (G-CSF) for stem cell mobilization allowed

Chemotherapy:

  • See Disease Characteristics
  • No prior anthracyclines or mitoxantrone
  • No concurrent chemotherapy for stem cell mobilization

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Trial locations and contacts

261 sites in 18 countries.

261 sites in 18 countries

Netherlands84 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5211 NL

  • Medisch Centrum Alkmaar

    Alkmaar, 1815 JD

  • Ijselmeer Ziekenhuis - Zuiderzeeziekenhuis

    Almere Stad, 1315RA

  • Meander Medisch Centrum

    Amersfont, 3016 CP

  • St. Lucas - Andreas Ziekenhuis

    Amsterdam, 1006 AE

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 1007 MB

  • Boveny Ziekenhuis

    Amsterdam, 1034 CS

  • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

    Amsterdam, 1066 CX

  • Slotervaart Ziekenhuis

    Amsterdam, 1066 EC

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 HA

  • Academisch Medisch Centrum at University of Amsterdam

    Amsterdam, 1105 AZ

  • Albert Schweitzerziekenhuis- Zwijndrecht

    Amsterdam

  • Scheperziekenhuis

    Amsterdam

  • Gelre Ziekenhuizen - Lokatie Lukas

    Apeldoorn, 7334 DZ

  • Ziekenhuis Lievensberg

    Bergen op Zoom, 4624 VT

  • Streekziekenhuis Gooi-Noord

    Blaricum, 1261 AN

  • Amphia Ziekenhuis - locatie Langendijk

    Breda, 4800 RL

  • Amphia Ziekenhuis - locatie Molengracht

    Breda, 4818 CK

  • Atrium Medical Centre - Brunssum

    Brunssum, 6442 BE

  • Ijsselland Ziekenhuis

    Capelle aan den IJssel, 2906 ZC

  • Reinier de Graaf Group - Delft

    Delft, NL 2600 GA

  • Gemini Ziekenhuis

    Den Helder, 1782 GZ

  • Deventer Ziekenhuisen

    Deventer, 7415 CM

  • Van Weel Bethesda Ziekenhuis

    Dirksland, 3247 BW

  • NIJ Smellinghe

    Drachten, NL-9200 DA

  • Diaconessenhuis Eindhoven

    Eindhoven, 5631 BM

  • Medisch Spectrum Twente

    Enschede, 7500 KA

  • St. Anna Ziekenhuis

    Geldrop, NL-5664

  • Beatrixziekenhuis

    Gorinchem

  • Groene Hart Ziekenhuis

    Gouda, 2803 HH

  • University Medical Center Groningen

    Groningen, 9713 GZ

  • Martini Ziekenhuis

    Groningen

  • Kennemer Gasthuis - Locatie EG

    Haarlem, 2000

  • Spaarne Ziekenhuis Haarlem

    Haarlem, 2012 CE

  • Ziekenhuis St Jansdal

    Harderwijk, 3840 AC

  • Tjongerschans Ziekenhuis

    Heerenveen, 8440 MA

  • Atrium Medical Centre - Heerlen

    Heerlen, 6419 PC

  • Elkerliek Ziekenhuis

    Helmond, 5707-HA

  • Streekziekenhuis Midden-Twente

    Hengelo, 7555 DL

  • Westfries Gasthuis

    Hoorn, 1624 AR

  • Zweedse Rode Kruis Ziekenhuis

    La Zierikzee, NL-4300

  • Medisch Centrum Leeuwarden - Zuid

    Leeuwarden, 8934 AD

  • Leiden University Medical Center

    Leiden, 2300 CA

  • Diaconessenhuis Leiden

    Leiden, 2300 RD

  • Rijnland Ziekenhuis

    Leiderdorp, 2350 CC

  • Medisch Centrum Haaglanden Antoniushove

    Leidschendam, 2262 BA

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202 AZ

  • Nederlandse Hervormde Diaconessenhuisinrichting

    Meppel, NL-7940

  • Sint Antonius Ziekenhuis

    Nieuwegein, 3435 CM

  • Nijmegen Cancer Center at Radboud University Medical Center

    Nijmegen, NL-6500 HB

  • Ziekenhuis Bernhoven

    Oss, 5340 BE

  • Waterlandziekenhuis

    Purmerend, 1440 AG

  • Saint Laurentius Ziekenhuis

    Roermond, 6043 CV

  • Saint Franciscus Ziekenhuis

    Roosendaal, 4708 AE

  • University Medical Center Rotterdam at Erasmus Medical Center

    Rotterdam, 3000 CA

  • St. Franciscus Gasthuis

    Rotterdam, 3045 PM

  • Medisch Centrum Rynmond-Zuid - Lokatie Zuider

    Rotterdam, 3075 AC

  • Medisch Centrum Rynmond Zuid - Lokatie: Clara

    Rotterdam, 3078 HT

  • Havenziekenhiuis

    Rotterdam, NL-3000

  • Ikazia Ziekenhuis

    Rotterdam, NL-3083

  • Maasland Hospital

    Sittard, 6131 BK

  • Albert Schweitzerziekenhuis- Sliedrecht

    Sliedrecht, NL-336

  • Ruwaard Van Putten Ziekenhuis

    Spykenisse, NL-3200 GA

  • Ziekenhuis Refaja

    Stadskanaal, NL-9501

  • Ziekenhuis de Honte

    Terneuzen, NL-4535

  • Hagaziekenhuis

    The Hague, 2545 CH

  • Red Cross Hospital

    The Hague, 2566 MJ

  • Rivierenland Tiel

    Tiel, NL-4000

  • St. Elisabeth Ziekenhuis

    Tilburg, 5022 GC

  • Twee Steden Ziekenhuis Vestiging Tilburg

    Tilburg, 5042 AD

  • University Medical Center Utrecht

    Utrecht, 3584 CX

  • Mesos Medisch Centrum - Overvecht

    Utrecht, NL-3563

  • Oudenrijn Ziekenhuis

    Utrecht

  • St. Joseph Veghel

    Veghel, NL-5461

  • Maxima Medisch Centrum - locatie Eindhoven

    Veldhoven, 5500 MB

  • Holy-Ziekenhuis

    Vlaardingen, NL-3130 GA

  • Reinier de Graaf Group - Voorburg

    Voorburg, 2275 CX

  • St. Jans Gasthuis Weert

    Weert Be, 6001

  • Hofpoort Ziekenhuis

    Woerden, NL-3445

  • Zaans Medisch Centrum

    Zaandam, 1502 DV

  • Lorentz Ziekenhuis

    Zeist, NL-3700

  • 'T Lange Land Ziekenhuis

    Zoetermeer, NL-2700

  • Isala Klinieken - locatie Sophia

    Zwolle, 8000 GK

  • Isala Klinieken - locatie Weezenlanden

    Zwolle, NL-8000 GM

Other trials in Netherlands

United Kingdom72 sites

  • Stoke Mandeville Hospital

    Aylesbury-Buckinghamshire, England, HP21 8AL

  • Royal United Hospital

    Bath, England, BA1 3NG

  • Belfast City Hospital Trust

    Belfast, Northern Ireland, BT9 7AB

  • City Hospital - Birmingham

    Birmingham, England, B18 7QH

  • Birmingham Heartlands Hospital

    Birmingham, England, B9 5SS

  • Blackpool Victoria Hospital

    Blackpool, England, FY3 8NR

  • Royal Bournemouth Hospital

    Bournemouth, England, BH7 7DW

  • Bradford Hospitals NHS Trust

    Bradford, England, BD9 6RJ

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

  • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

    Cambridge, England, CB2 2QQ

  • Conquest Hospital

    Canterbury, England, CT2 7NR

  • Kent and Canterbury Hospital

    Canterbury, England, CT2 7NR

  • Velindre Cancer Center at Velinde Hospital

    Cardiff, Wales, CF14 2TL

  • University Hospital of Wales

    Cardiff, Wales, CF14 4XN

  • St Helier Hospital

    Carshalton, England, SM5 1AA

  • Cheltenham General Hospital

    Cheltenham, England, GL53 7AN

  • Countess of Chester Hospital

    Chester, England, CH2 1UL

  • Saint Richards Hospital

    Chichester, P019 4SE

  • Essex County Hospital

    Colchester, England, C03 3NB

  • Doncaster Royal Infirmary

    Doncaster, England, DN2 5LT

  • Russells Hall Hospital

    Dudley, England, DY1 2HQ

  • Western General Hospital

    Edinburgh, Scotland, EH4 2XU

  • Royal Devon and Exeter Hospital

    Exeter, England, EX2 5DW

  • Queen Elizabeth Hospital

    Gateshead, England, NE9 6SX

  • Western Infirmary

    Glasgow, Scotland, G11 6NT

  • Royal Infirmary - Castle

    Glasgow, Scotland, G4 0SF

  • Southern General Hospital

    Glasgow, Scotland, G51 4TF

  • Diana Princess of Wales Hospital

    Grimsby, England, DN33 2BA

  • Royal Free and University College Medical School

    Hampstead, London, England, NW3 2QG

  • Hull Royal Infirmary

    Hull, HU3 2KZ

  • Hinchingbrooke Hospital

    Huntingdon, England, PE18 6NT

  • King George Hospital

    Ilford, Essex, England, IG3 8YB

  • Kettering General Hosptial

    Kettering, Northants, NNI6 8UZ

  • Leeds General Infirmary at Leeds Teaching Hospital NHS Trust

    Leeds, England, LS1 3EX

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

  • Royal Liverpool University Hospital

    Liverpool, England, L69 3GA

  • Aintree University Hospital

    Liverpool, England, L9 7AL

  • Saint Bartholomew's Hospital

    London, England, EC1A 7BE

  • Guy's and St. Thomas' Hospitals NHS Foundation Trust

    London, England, SE1 9RT

  • St. George's Hospital

    London, England, SW17 0QT

  • St. Georges Hospital Medical School

    London, England, SW17 ORE

  • Royal Marsden NHS Foundation Trust - London

    London, England, SW3 6JJ

  • University College Hospital

    London, England, WC1E 6AU

  • Clatterbridge Centre for Oncology NHS Trust

    Merseyside, England, CH63 4JY

  • James Cook University Hospital

    Middlesbrough, England, TS4 3BW

  • Newcastle Upon Tyne Hospitals NHS Trust

    Newcastle upon Tyne, England, NE7 7DN

  • Royal Gwent Hospital

    Newport Gwent, Wales, NP9 2UB

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

  • Norfolk and Norwich University Hospital

    Norwich, England, NR1 3SR

  • Oxford Radcliffe Hospital

    Oxford, England, 0X3 9DU

  • Portsmouth Hospitals NHS Trust

    Portsmouth, England, P03 6AD

  • Whiston Hospital

    Prescot Merseyside, England, L35 5DR

  • Royal Preston Hospital

    Preston, England, PR2 9HT

  • Berkshire Cancer Centre at Royal Berkshire Hospital

    Reading, England, RG1 5AN

  • Glan Clywd District General Hospital

    Rhyl, Denbighshire, Wales, LL 18 5UJ

  • Oldchurch Hospital

    Romford, England, RM7 OBE

  • Pembury Hospital

    Royal Tunbridge Wells, Kent, England, TN2 4QJ

  • Salisbury District Hospital

    Salisbury, England, SP2 8BJ

  • Scunthorpe General Hospital

    Scunthorpe, England, DN15 7BH

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S1O 2SJ

  • Southampton General Hospital

    Southampton, England, SO16 6YD

  • Staffordshire General Hospital

    Stafford, ST16 3SA

  • North Staffs Royal Infirmary

    Stoke-on-Trent, England, ST4 7LN

  • Royal Marsden NHS Foundation Trust - Surrey

    Sutton, England, SM2 5PT

  • Singleton Hospital

    Swansea, England, SA 2 8QA

  • Great Western Hospital

    Swindon, SN1 4JU

  • Taunton and Somerset Hospital

    Taunton Somerset, England, TA1 5DA

  • Torbay Hospital

    Torquay Devon, England, TQ2 7AA

  • Hillingdon Hospital

    Uxbridge, England, UB8 3NN

  • Sandwell General Hospital

    West Bromwich, England, B71 4HJ

  • Royal Hampshire County Hospital

    Winchester, England, SO22 5DG

  • New Cross Hospital

    Wolverhampton, England, WV10 0QP

Other trials in United Kingdom

Australia37 sites

  • Royal Adelaide Hospital Cancer Centre

    Adelaide, South Australia, 5000

  • Ashford Cancer Centre

    Ashford, South Australia, 5035

  • Wesley Medical Centre

    Auchenflower, Queensland, 4066

  • St. John of God Hospital

    Ballarat, Victoria, 3350

  • Flinder Medical Centres

    Bedford Park, South Australia, 5042

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • John Fawkner Hospital

    Coburg, Victoria, 3058

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Peter MacCallum Cancer Centre

    East Melbourne, Victoria, 8006

  • St. Vincent's Hospital

    Fitzroy, Victoria, 3065

  • Frankston Hospital

    Frankston, Victoria, 3199

  • Fremantle Hospital

    Fremantle, Western Australia, 6160

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Geelong Hospital

    Geelong, Victoria, 3200

  • Greenslopes Private Hospital

    Greenslopes, Queensland, 4120

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Cancer Therapy Centre at Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Alfred Hospital

    Melbourne, Victoria, 3181

  • Garden Consulting Rooms

    Mornington, Victoria, 3931

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Mount Medical Centre

    Perth, Western Australia, 6000

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Sir Charles Gairdner Hospital - Perth

    Perth, Western Australia, 6009

  • Institute of Oncology at Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Prince of Wales Private Hospital

    Randwick, New South Wales, NSW 2031

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • St. Vincent's Hospital

    Sydney, New South Wales, 2010

  • Sydney Cancer Centre at Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050

  • St. George Hospital and Community Health Service

    Sydney, New South Wales, 2217

  • Townsville General Hospital

    Townsville, Queensland, 4810

  • Westmead Breast Centre at NSW Breast Cancer Institute

    Westmead, New South Wales, 2145

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Wollongong Hospital

    Wollongong, New South Wales, 2500

  • Queen Elizabeth Hospital

    Woodville, South Australia, 5011

Other trials in Australia

Canada32 sites

  • Royal Victoria Hospital of Barrie

    Barrie, Ontario, L4M 6M2

  • Tom Baker Cancer Centre - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute at University of Alberta

    Edmonton, Alberta, T6G 1Z2

  • Northeastern Ontario Regional Cancer Centre

    Greater Sudbury, Ontario, P3E 5J1

  • Hopital Charles Lemoyne

    Greenfield Park, Quebec, J4V 2H1

  • Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • British Columbia Cancer Agency - Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Cancer Centre of Southeastern Ontario at Kingston General Hospital

    Kingston, Ontario, K7L 5P9

  • London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Trillium Health Centre - Mississauga Site

    Mississauga, Ontario, L5B 1B8

  • Moncton Hospital

    Moncton, New Brunswick, E1C 6ZB

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • McGill Cancer Centre at McGill University

    Montreal, Quebec, H2W 1S6

  • Hopital Du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • Hopital Notre- Dame du CHUM

    Montreal, Quebec, H4L 2M1

  • Nanaimo Cancer Clinic at Nanaimo Regional General Hospital

    Nanaimo, British Columbia, V9S 2B7

  • Lions Gate Hospital

    North Vancouver, British Columbia, V7L 2P9

  • Ottawa Hospital Regional Cancer Centre - General Campus

    Ottawa, Ontario, K1H 1C4

  • Hopital du Saint-Sacrement, Quebec

    Québec, Quebec, G1S 4L8

  • Allan Blair Cancer Centre at Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

  • Hotel Dieu Health Sciences Hospital - Niagara

    St. Catharines, Ontario, L2R 5K3

  • Newfoundland Cancer Treatment and Research Foundation

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Fraser Valley Cancer Centre at British Columbia Cancer Agency

    Surrey, British Columbia, V3V 1Z2

  • Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario, P7A 7T1

  • Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • St. Joseph's Health Centre - Toronto

    Toronto, Ontario, M6R 1B5

  • British Columbia Cancer Agency - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • Humber River Regional Hospital - Weston

    Weston, Ontario, M9N 1N8

  • Windsor Regional Cancer Centre at Windsor Regional Hospital

    Windsor, Ontario, N8W 2X3

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Sweden8 sites

  • Sahlgrenska University Hospital at Gothenburg University

    Gothenburg (Goteborg), S-413 45

  • University Hospital of Linkoping

    Linköping, S-581 85

  • Sunderby Hospital

    Luleå, 95128

  • Lund University Hospital

    Lund, S-22185

  • Orebro University Hospital

    Örebro, 70185

  • Karolinska University Hospital - Huddinge

    Stockholm, S-141 86

  • Sundsvall Hospital

    Sundsvall, 85186

  • Umea Universitet

    Umeå, S-901 85

Other trials in Sweden

Belgium7 sites

  • Ziekenhuis Netwerk Antwerpen Middelheim

    Antwerp, 2020

  • Institut Jules Bordet

    Brussels, 1000

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • Algemeen Ziekenhuis Sint Lucas

    Ghent, B-9000

  • U.Z. Gasthuisberg

    Leuven, B-3000

  • H. Hartziekenhuis - Roeselaere.

    Roeselare, 8800

  • Algemeen Ziekenhuis Sint-Augustinus

    Wilrijk, 2610

Other trials in Belgium

South Africa4 sites

  • Mary Potter Oncology Centre

    Brooklyn Square, 1577

  • Sandton Oncology Centre

    Johannesburg, 2121

  • Medical Oncology Centre of Rosebank

    Johannesburg, 2193

  • Johannesburg General Hospital

    Parktown, 2193

Other trials in South Africa

New Zealand3 sites

  • University of Auckland School of Medicine

    Auckland, 3

  • Christchurch Hospital

    Christchurch, 1

  • Waikato Hospital

    Hamilton, 2020

Other trials in New Zealand

Norway3 sites

  • Haukeland Hospital - University of Bergen

    Bergen, N-5021

  • Norwegian Radium Hospital

    Oslo, N-0310

  • St. Olavs University Hospital

    Trondheim, 7006

Other trials in Norway

Denmark2 sites

  • Rigshospitalet - Copenhagen University Hospital

    Copenhagen, 2100

  • Vejle Sygehus

    Vejle, 7100

Other trials in Denmark

France2 sites

  • Institut Bergonie

    Bordeaux, 33076

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Egypt1 site

  • National Cancer Institute of Egypt

    Cairo

Other trials in Egypt

Hungary1 site

  • National Institute of Oncology

    Budapest, 1125

Other trials in Hungary

Italy1 site

  • Centro di Riferimento Oncologico - Aviano

    Aviano, 33081

Other trials in Italy

Poland1 site

  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

    Warsaw, 02-781

Other trials in Poland

Portugal1 site

  • Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.

    Lisbon, 1099-023 Codex

Other trials in Portugal

Slovakia1 site

  • National Cancer Institute - Bratislava

    Bratislava, 833 10

Other trials in Slovakia

Slovenia1 site

  • Institute of Oncology - Ljubljana

    Ljubljana, Sl-1000

Other trials in Slovenia

About this study

Official title: Chimeric Anti-CD20 Monoclonal Antibody (Mabthera) in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkin's Lymphoma: A Phase III Randomized Clinical Trial - Intergroup Collaborative Study

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 cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether chemotherapy is more effective with or without rituximab for relapsed non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and rituximab to see how well they work compared to combination chemotherapy alone in treating patients with relapsed non-Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES:

  • Compare the response rate and quality of remission in patients with relapsed follicular non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with or without rituximab.
  • Compare the event-free survival and overall survival of patients treated with these regimens.
  • Determine the effect of rituximab as maintenance therapy on progression-free survival of these patients.

OUTLINE: This is a randomized, multicenter study.

  • Induction: Patients are randomized to one of two treatment arms. Patients are stratified according to participating center, prior treatment with purine analogues, age, number of prior induction treatments and best response obtained (complete vs partial remission vs no change/progressive disease), time since diagnosis (less than 2 years vs more than 2 years), and bulky disease (less than 10 cm vs greater than 10 cm).
  • Arm I (closed as of 12/20/04): Patients receive induction chemotherapy comprising cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5 (CHOP chemotherapy). Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive CHOP chemotherapy as in arm I. Rituximab IV is administered 1 hour after prednisone and before the IV drugs.
  • Maintenance: Patients who achieve partial or complete remission are then randomized to one of two treatment arms. Patients are stratified according to rituximab administration during induction (yes vs no), quality of the response (complete vs partial remission vs no change/progressive disease), and participating center.
  • Arm I: Patients receive no further therapy.
  • Arm II: Beginning 8 weeks after the last CHOP course, patients receive rituximab IV once every 3 months for up to 2 years in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 4 months thereafter.

PROJECTED ACCRUAL: A total of 752 patients will be accrued for this study within 6 years.

Conditions
Lymphoma
Keywords
stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma
Medical subject headings
Lymphoma, Lymphoma, Follicular

What participants receive

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

What is being measured

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

  1. Response to treatment

Secondary outcomes (2)

  1. Overall survival

    Measured: from randomization

  2. Progression Free survival

    Measured: from randomization

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 startMay 1999
  3. Primary completionApr 2004
  4. Study completion19 Jul 2017

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
Enrolment
475 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00004179
Sponsor's protocol ID
EORTC-20981
Other IDs
EORTC-20981, ALLG-NHLLOW4, BNLI-EORTC-20981, HOVON-H039, CAN-NCIC-LY7, NORDIC-EORTC-20981
Status last verified
Feb 2021
First submitted
21 Jan 2000
Last updated
15 Feb 2021
Results posted
No

Publications

  • Deconinck E, Miadi-Fargier H, Pen CL, Brice P. Cost effectiveness of rituximab maintenance therapy in follicular lymphoma: long-term economic evaluation. Pharmacoeconomics. 2010;28(1):35-46. doi: 10.2165/11314070-000000000-00000.

    PubMed 20014875

  • Pompen M, Huijgens PC, et al.: Cost-effectiveness of rituximab for maintenance in patients with follicular non-Hodgkin's lymphoma in the Dutch setting. [Abstract] Blood 112 (11): A-2364, 2008.

  • Van Oers MH, Hagenbeek A, Van Glabbeke M, Teodorovic I. Chimeric anti-CD20 monoclonal antibody (Mabthera) in remission induction and maintenance treatment of relapsed follicular non-Hodgkin's lymphoma: a phase III randomized clinical trial--Intergroup Collaborative Study. Ann Hematol. 2002 Oct;81(10):553-7. doi: 10.1007/s00277-002-0548-2. Epub 2002 Oct 17. No abstract available.

    PubMed 12424535

  • van Oers MH, Tonnissen E, Van Glabbeke M, Giurgea L, Jansen JH, Klasa R, Marcus RE, Wolf M, Kimby E, Vranovsky A, Holte H, Hagenbeek A, van der Reijden BA. BCL-2/IgH polymerase chain reaction status at the end of induction treatment is not predictive for progression-free survival in relapsed/resistant follicular lymphoma: results of a prospective randomized EORTC 20981 phase III intergroup study. J Clin Oncol. 2010 May 1;28(13):2246-52. doi: 10.1200/JCO.2009.25.0852. Epub 2010 Apr 5.

    PubMed 20368567

  • van Oers MH, Van Glabbeke M, Giurgea L, Klasa R, Marcus RE, Wolf M, Kimby E, van t Veer M, Vranovsky A, Holte H, Hagenbeek A. Rituximab maintenance treatment of relapsed/resistant follicular non-Hodgkin's lymphoma: long-term outcome of the EORTC 20981 phase III randomized intergroup study. J Clin Oncol. 2010 Jun 10;28(17):2853-8. doi: 10.1200/JCO.2009.26.5827. Epub 2010 May 3.

    PubMed 20439641

  • van Oers MH, Klasa R, Marcus RE, Wolf M, Kimby E, Gascoyne RD, Jack A, Van't Veer M, Vranovsky A, Holte H, van Glabbeke M, Teodorovic I, Rozewicz C, Hagenbeek A. Rituximab maintenance improves clinical outcome of relapsed/resistant follicular non-Hodgkin lymphoma in patients both with and without rituximab during induction: results of a prospective randomized phase 3 intergroup trial. Blood. 2006 Nov 15;108(10):3295-301. doi: 10.1182/blood-2006-05-021113. Epub 2006 Jul 27.

    PubMed 16873669

  • Mattiola I, Mantovani A, Locati M. The tetraspan MS4A family in homeostasis, immunity, and disease. Trends Immunol. 2021 Sep;42(9):764-781. doi: 10.1016/j.it.2021.07.002. Epub 2021 Aug 9.

    PubMed 34384709

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rituximab, CHOP regimen and cyclophosphamide in people with Lymphoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 261 sites in 18 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 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 261 sites in Netherlands, United Kingdom, Australia, Canada, Sweden and 13 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?

Response to 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 NCT00004179, which also lists 7 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 15 Feb 2021.

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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT00004179 | AzTrials