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

NCT ID: NCT00004179

Last Updated: 2021-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 475 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-05-31
• Study Completion Date: 2017-07-19

Brief 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. 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

rituximab

Intervention Type: BIOLOGICAL

CHOP regimen

Intervention Type: DRUG

cyclophosphamide

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

vincristine sulfate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lymphoma Trials Office

OTHER

Sponsor Role: collaborator

Stichting Hemato-Oncologie voor Volwassenen Nederland

OTHER

Sponsor Role: collaborator

Australasian Leukaemia and Lymphoma Group

OTHER

Sponsor Role: collaborator

NCIC Clinical Trials Group

NETWORK

Sponsor Role: collaborator

Nordic Lymphoma Group

NETWORK

Sponsor Role: collaborator

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

M. H. J. Van Oers, MD

Role: STUDY_CHAIR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Robert Marcus, MD

Role: STUDY_CHAIR

Cambridge University Hospitals NHS Foundation Trust

Max M. Wolf, MD

Role: STUDY_CHAIR

Peter MacCallum Cancer Centre, Australia

Richard J. Klasa, MD

Role: STUDY_CHAIR

British Columbia Cancer Agency

Eva K. Kimby, MD, PhD

Role: STUDY_CHAIR

Karolinska Institutet

Locations

Bradford Hospitals NHS Trust

Bradford, England, United Kingdom

Canberra Hospital

Garran, Australian Capital Territory, Australia

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Cancer Therapy Centre at Liverpool Hospital

Liverpool, New South Wales, Australia

Institute of Oncology at Prince of Wales Hospital

Randwick, New South Wales, Australia

Prince of Wales Private Hospital

Randwick, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

St. Vincent's Hospital

Sydney, New South Wales, Australia

Sydney Cancer Centre at Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

St. George Hospital and Community Health Service

Sydney, New South Wales, Australia

Westmead Breast Centre at NSW Breast Cancer Institute

Westmead, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

Wesley Medical Centre

Auchenflower, Queensland, Australia

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Greenslopes Private Hospital

Greenslopes, Queensland, Australia

Townsville General Hospital

Townsville, Queensland, Australia

Royal Adelaide Hospital Cancer Centre

Adelaide, South Australia, Australia

Ashford Cancer Centre

Ashford, South Australia, Australia

Flinder Medical Centres

Bedford Park, South Australia, Australia

Queen Elizabeth Hospital

Woodville, South Australia, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

St. John of God Hospital

Ballarat, Victoria, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

John Fawkner Hospital

Coburg, Victoria, Australia

Peter MacCallum Cancer Centre

East Melbourne, Victoria, Australia

St. Vincent's Hospital

Fitzroy, Victoria, Australia

Frankston Hospital

Frankston, Victoria, Australia

Geelong Hospital

Geelong, Victoria, Australia

Austin Hospital

Heidelberg, Victoria, Australia

Alfred Hospital

Melbourne, Victoria, Australia

Garden Consulting Rooms

Mornington, Victoria, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Fremantle Hospital

Fremantle, Western Australia, Australia

Mount Medical Centre

Perth, Western Australia, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Sir Charles Gairdner Hospital - Perth

Perth, Western Australia, Australia

Ziekenhuis Netwerk Antwerpen Middelheim

Antwerp, , Belgium

Institut Jules Bordet

Brussels, , Belgium

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Algemeen Ziekenhuis Sint Lucas

Ghent, , Belgium

U.Z. Gasthuisberg

Leuven, , Belgium

H. Hartziekenhuis - Roeselaere.

Roeselare, , Belgium

Algemeen Ziekenhuis Sint-Augustinus

Wilrijk, , Belgium

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, Canada

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, Canada

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, Canada

Nanaimo Cancer Clinic at Nanaimo Regional General Hospital

Nanaimo, British Columbia, Canada

Lions Gate Hospital

North Vancouver, British Columbia, Canada

Fraser Valley Cancer Centre at British Columbia Cancer Agency

Surrey, British Columbia, Canada

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Moncton Hospital

Moncton, New Brunswick, Canada

Newfoundland Cancer Treatment and Research Foundation

St. John's, Newfoundland and Labrador, Canada

Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Royal Victoria Hospital of Barrie

Barrie, Ontario, Canada

Northeastern Ontario Regional Cancer Centre

Greater Sudbury, Ontario, Canada

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, Canada

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, Canada

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, Canada

Trillium Health Centre - Mississauga Site

Mississauga, Ontario, Canada

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, Canada

Hotel Dieu Health Sciences Hospital - Niagara

St. Catharines, Ontario, Canada

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

Thunder Bay, Ontario, Canada

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

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

St. Joseph's Health Centre - Toronto

Toronto, Ontario, Canada

Humber River Regional Hospital - Weston

Weston, Ontario, Canada

Windsor Regional Cancer Centre at Windsor Regional Hospital

Windsor, Ontario, Canada

Hopital Charles Lemoyne

Greenfield Park, Quebec, Canada

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

McGill Cancer Centre at McGill University

Montreal, Quebec, Canada

Hopital Du Sacre-Coeur de Montreal

Montreal, Quebec, Canada

Hopital Notre- Dame du CHUM

Montreal, Quebec, Canada

Hopital du Saint-Sacrement, Quebec

Québec, Quebec, Canada

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, Canada

Bristol Haematology and Oncology Centre

Bristol, England, United Kingdom

Rigshospitalet - Copenhagen University Hospital

Copenhagen, , Denmark

Vejle Sygehus

Vejle, , Denmark

National Cancer Institute of Egypt

Cairo, , Egypt

Institut Bergonie

Bordeaux, , France

Institut Gustave Roussy

Villejuif, , France

National Institute of Oncology

Budapest, , Hungary

Centro di Riferimento Oncologico - Aviano

Aviano, , Italy

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

Medisch Centrum Alkmaar

Alkmaar, , Netherlands

Ijselmeer Ziekenhuis - Zuiderzeeziekenhuis

Almere Stad, , Netherlands

Meander Medisch Centrum

Amersfont, , Netherlands

St. Lucas - Andreas Ziekenhuis

Amsterdam, , Netherlands

Vrije Universiteit Medisch Centrum

Amsterdam, , Netherlands

Boveny Ziekenhuis

Amsterdam, , Netherlands

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, , Netherlands

Slotervaart Ziekenhuis

Amsterdam, , Netherlands

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, , Netherlands

Albert Schweitzerziekenhuis- Zwijndrecht

Amsterdam, , Netherlands

Scheperziekenhuis

Amsterdam, , Netherlands

Gelre Ziekenhuizen - Lokatie Lukas

Apeldoorn, , Netherlands

Ziekenhuis Lievensberg

Bergen op Zoom, , Netherlands

Streekziekenhuis Gooi-Noord

Blaricum, , Netherlands

Amphia Ziekenhuis - locatie Langendijk

Breda, , Netherlands

Amphia Ziekenhuis - locatie Molengracht

Breda, , Netherlands

Atrium Medical Centre - Brunssum

Brunssum, , Netherlands

Ijsselland Ziekenhuis

Capelle aan den IJssel, , Netherlands

Reinier de Graaf Group - Delft

Delft, , Netherlands

Gemini Ziekenhuis

Den Helder, , Netherlands

Deventer Ziekenhuisen

Deventer, , Netherlands

Van Weel Bethesda Ziekenhuis

Dirksland, , Netherlands

NIJ Smellinghe

Drachten, , Netherlands

Diaconessenhuis Eindhoven

Eindhoven, , Netherlands

Medisch Spectrum Twente

Enschede, , Netherlands

St. Anna Ziekenhuis

Geldrop, , Netherlands

Beatrixziekenhuis

Gorinchem, , Netherlands

Groene Hart Ziekenhuis

Gouda, , Netherlands

University Medical Center Groningen

Groningen, , Netherlands

Martini Ziekenhuis

Groningen, , Netherlands

Kennemer Gasthuis - Locatie EG

Haarlem, , Netherlands

Spaarne Ziekenhuis Haarlem

Haarlem, , Netherlands

Ziekenhuis St Jansdal

Harderwijk, , Netherlands

Tjongerschans Ziekenhuis

Heerenveen, , Netherlands

Atrium Medical Centre - Heerlen

Heerlen, , Netherlands

Elkerliek Ziekenhuis

Helmond, , Netherlands

Streekziekenhuis Midden-Twente

Hengelo, , Netherlands

Westfries Gasthuis

Hoorn, , Netherlands

Zweedse Rode Kruis Ziekenhuis

La Zierikzee, , Netherlands

Medisch Centrum Leeuwarden - Zuid

Leeuwarden, , Netherlands

Leiden University Medical Center

Leiden, , Netherlands

Diaconessenhuis Leiden

Leiden, , Netherlands

Rijnland Ziekenhuis

Leiderdorp, , Netherlands

Medisch Centrum Haaglanden Antoniushove

Leidschendam, , Netherlands

Academisch Ziekenhuis Maastricht

Maastricht, , Netherlands

Nederlandse Hervormde Diaconessenhuisinrichting

Meppel, , Netherlands

Sint Antonius Ziekenhuis

Nieuwegein, , Netherlands

Nijmegen Cancer Center at Radboud University Medical Center

Nijmegen, , Netherlands

Ziekenhuis Bernhoven

Oss, , Netherlands

Waterlandziekenhuis

Purmerend, , Netherlands

Saint Laurentius Ziekenhuis

Roermond, , Netherlands

Saint Franciscus Ziekenhuis

Roosendaal, , Netherlands

University Medical Center Rotterdam at Erasmus Medical Center

Rotterdam, , Netherlands

St. Franciscus Gasthuis

Rotterdam, , Netherlands

Medisch Centrum Rynmond-Zuid - Lokatie Zuider

Rotterdam, , Netherlands

Medisch Centrum Rynmond Zuid - Lokatie: Clara

Rotterdam, , Netherlands

Havenziekenhiuis

Rotterdam, , Netherlands

Ikazia Ziekenhuis

Rotterdam, , Netherlands

Maasland Hospital

Sittard, , Netherlands

Albert Schweitzerziekenhuis- Sliedrecht

Sliedrecht, , Netherlands

Ruwaard Van Putten Ziekenhuis

Spykenisse, , Netherlands

Ziekenhuis Refaja

Stadskanaal, , Netherlands

Ziekenhuis de Honte

Terneuzen, , Netherlands

Hagaziekenhuis

The Hague, , Netherlands

Red Cross Hospital

The Hague, , Netherlands

Rivierenland Tiel

Tiel, , Netherlands

St. Elisabeth Ziekenhuis

Tilburg, , Netherlands

Twee Steden Ziekenhuis Vestiging Tilburg

Tilburg, , Netherlands

University Medical Center Utrecht

Utrecht, , Netherlands

Mesos Medisch Centrum - Overvecht

Utrecht, , Netherlands

Oudenrijn Ziekenhuis

Utrecht, , Netherlands

St. Joseph Veghel

Veghel, , Netherlands

Maxima Medisch Centrum - locatie Eindhoven

Veldhoven, , Netherlands

Holy-Ziekenhuis

Vlaardingen, , Netherlands

Reinier de Graaf Group - Voorburg

Voorburg, , Netherlands

St. Jans Gasthuis Weert

Weert Be, , Netherlands

Hofpoort Ziekenhuis

Woerden, , Netherlands

Zaans Medisch Centrum

Zaandam, , Netherlands

Lorentz Ziekenhuis

Zeist, , Netherlands

'T Lange Land Ziekenhuis

Zoetermeer, , Netherlands

Isala Klinieken - locatie Sophia

Zwolle, , Netherlands

Isala Klinieken - locatie Weezenlanden

Zwolle, , Netherlands

University of Auckland School of Medicine

Auckland, , New Zealand

Christchurch Hospital

Christchurch, , New Zealand

Waikato Hospital

Hamilton, , New Zealand

Haukeland Hospital - University of Bergen

Bergen, , Norway

Norwegian Radium Hospital

Oslo, , Norway

St. Olavs University Hospital

Trondheim, , Norway

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, , Poland

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

Lisbon, , Portugal

National Cancer Institute - Bratislava

Bratislava, , Slovakia

Institute of Oncology - Ljubljana

Ljubljana, , Slovenia

Mary Potter Oncology Centre

Brooklyn Square, , South Africa

Sandton Oncology Centre

Johannesburg, , South Africa

Medical Oncology Centre of Rosebank

Johannesburg, , South Africa

Johannesburg General Hospital

Parktown, , South Africa

Sahlgrenska University Hospital at Gothenburg University

Gothenburg (Goteborg), , Sweden

University Hospital of Linkoping

Linköping, , Sweden

Sunderby Hospital

Luleå, , Sweden

Lund University Hospital

Lund, , Sweden

Orebro University Hospital

Örebro, , Sweden

Karolinska University Hospital - Huddinge

Stockholm, , Sweden

Sundsvall Hospital

Sundsvall, , Sweden

Umea Universitet

Umeå, , Sweden

Stoke Mandeville Hospital

Aylesbury-Buckinghamshire, England, United Kingdom

Royal United Hospital

Bath, England, United Kingdom

City Hospital - Birmingham

Birmingham, England, United Kingdom

Birmingham Heartlands Hospital

Birmingham, England, United Kingdom

Blackpool Victoria Hospital

Blackpool, England, United Kingdom

Royal Bournemouth Hospital

Bournemouth, England, United Kingdom

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, United Kingdom

Conquest Hospital

Canterbury, England, United Kingdom

Kent and Canterbury Hospital

Canterbury, England, United Kingdom

St Helier Hospital

Carshalton, England, United Kingdom

Cheltenham General Hospital

Cheltenham, England, United Kingdom

Countess of Chester Hospital

Chester, England, United Kingdom

Essex County Hospital

Colchester, England, United Kingdom

Doncaster Royal Infirmary

Doncaster, England, United Kingdom

Russells Hall Hospital

Dudley, England, United Kingdom

Royal Devon and Exeter Hospital

Exeter, England, United Kingdom

Queen Elizabeth Hospital

Gateshead, England, United Kingdom

Diana Princess of Wales Hospital

Grimsby, England, United Kingdom

Royal Free and University College Medical School

Hampstead, London, England, United Kingdom

Hinchingbrooke Hospital

Huntingdon, England, United Kingdom

King George Hospital

Ilford, Essex, England, United Kingdom

Leeds General Infirmary at Leeds Teaching Hospital NHS Trust

Leeds, England, United Kingdom

Leicester Royal Infirmary

Leicester, England, United Kingdom

Royal Liverpool University Hospital

Liverpool, England, United Kingdom

Aintree University Hospital

Liverpool, England, United Kingdom

Saint Bartholomew's Hospital

London, England, United Kingdom

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

London, England, United Kingdom

St. George's Hospital

London, England, United Kingdom

St. Georges Hospital Medical School

London, England, United Kingdom

Royal Marsden NHS Foundation Trust - London

London, England, United Kingdom

University College Hospital

London, England, United Kingdom

Clatterbridge Centre for Oncology NHS Trust

Merseyside, England, United Kingdom

James Cook University Hospital

Middlesbrough, England, United Kingdom

Newcastle Upon Tyne Hospitals NHS Trust

Newcastle upon Tyne, England, United Kingdom

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, United Kingdom

Norfolk and Norwich University Hospital

Norwich, England, United Kingdom

Oxford Radcliffe Hospital

Oxford, England, United Kingdom

Portsmouth Hospitals NHS Trust

Portsmouth, England, United Kingdom

Whiston Hospital

Prescot Merseyside, England, United Kingdom

Royal Preston Hospital

Preston, England, United Kingdom

Berkshire Cancer Centre at Royal Berkshire Hospital

Reading, England, United Kingdom

Oldchurch Hospital

Romford, England, United Kingdom

Pembury Hospital

Royal Tunbridge Wells, Kent, England, United Kingdom

Salisbury District Hospital

Salisbury, England, United Kingdom

Scunthorpe General Hospital

Scunthorpe, England, United Kingdom

Cancer Research Centre at Weston Park Hospital

Sheffield, England, United Kingdom

Southampton General Hospital

Southampton, England, United Kingdom

North Staffs Royal Infirmary

Stoke-on-Trent, England, United Kingdom

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, United Kingdom

Singleton Hospital

Swansea, England, United Kingdom

Taunton and Somerset Hospital

Taunton Somerset, England, United Kingdom

Torbay Hospital

Torquay Devon, England, United Kingdom

Hillingdon Hospital

Uxbridge, England, United Kingdom

Sandwell General Hospital

West Bromwich, England, United Kingdom

Royal Hampshire County Hospital

Winchester, England, United Kingdom

New Cross Hospital

Wolverhampton, England, United Kingdom

Belfast City Hospital Trust

Belfast, Northern Ireland, United Kingdom

Western General Hospital

Edinburgh, Scotland, United Kingdom

Western Infirmary

Glasgow, Scotland, United Kingdom

Royal Infirmary - Castle

Glasgow, Scotland, United Kingdom

Southern General Hospital

Glasgow, Scotland, United Kingdom

Velindre Cancer Center at Velinde Hospital

Cardiff, Wales, United Kingdom

University Hospital of Wales

Cardiff, Wales, United Kingdom

Royal Gwent Hospital

Newport Gwent, Wales, United Kingdom

Glan Clywd District General Hospital

Rhyl, Denbighshire, Wales, United Kingdom

Saint Richards Hospital

Chichester, , United Kingdom

Hull Royal Infirmary

Hull, , United Kingdom

Kettering General Hosptial

Kettering, Northants, , United Kingdom

Staffordshire General Hospital

Stafford, , United Kingdom

Great Western Hospital

Swindon, , United Kingdom

Countries

Australia; Belgium; Canada; Denmark; Egypt; France; Hungary; Italy; Netherlands; New Zealand; Norway; Poland; Portugal; Slovakia; Slovenia; South Africa; Sweden; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 20014875 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 12424535 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20368567 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20439641 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16873669 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34384709 (View on PubMed)

Other Identifiers

EORTC-20981

Identifier Type: OTHER

Identifier Source: secondary_id

ALLG-NHLLOW4

Identifier Type: OTHER

Identifier Source: secondary_id

BNLI-EORTC-20981

Identifier Type: OTHER

Identifier Source: secondary_id

HOVON-H039

Identifier Type: OTHER

Identifier Source: secondary_id

CAN-NCIC-LY7

Identifier Type: OTHER

Identifier Source: secondary_id

NORDIC-EORTC-20981

Identifier Type: OTHER

Identifier Source: secondary_id

EORTC-20981

Identifier Type: -

Identifier Source: org_study_id