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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004179
• Other study ID #: EORTC-20981
• Secondary ID: EORTC-20981ALLG-
• Status: Completed
• Phase: Phase 3
• Start date: May 1999
• Est. completion date: July 19, 2017

Study information

• Verified date: February 2021
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 475
• Est. completion date: July 19, 2017
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Biological:
• rituximab

Drug:
• CHOP regimen

• cyclophosphamide

• doxorubicin hydrochloride

• prednisone

• vincristine sulfate

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital Cancer Centre	Adelaide	South Australia
Australia	Ashford Cancer Centre	Ashford	South Australia
Australia	Wesley Medical Centre	Auchenflower	Queensland
Australia	St. John of God Hospital	Ballarat	Victoria
Australia	Flinder Medical Centres	Bedford Park	South Australia
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Royal Brisbane and Women's Hospital	Brisbane	Queensland
Australia	John Fawkner Hospital	Coburg	Victoria
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	Peter MacCallum Cancer Centre	East Melbourne	Victoria
Australia	St. Vincent's Hospital	Fitzroy	Victoria
Australia	Frankston Hospital	Frankston	Victoria
Australia	Fremantle Hospital	Fremantle	Western Australia
Australia	Canberra Hospital	Garran	Australian Capital Territory
Australia	Geelong Hospital	Geelong	Victoria
Australia	Greenslopes Private Hospital	Greenslopes	Queensland
Australia	Austin Hospital	Heidelberg	Victoria
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Cancer Therapy Centre at Liverpool Hospital	Liverpool	New South Wales
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Garden Consulting Rooms	Mornington	Victoria
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Mount Medical Centre	Perth	Western Australia
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Sir Charles Gairdner Hospital - Perth	Perth	Western Australia
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. George Hospital and Community Health Service	Sydney	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	Townsville General Hospital	Townsville	Queensland
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	Queen Elizabeth Hospital	Woodville	South Australia
Belgium	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
Canada	Royal Victoria Hospital of Barrie	Barrie	Ontario
Canada	Tom Baker Cancer Centre - Calgary	Calgary	Alberta
Canada	Cross Cancer Institute at University of Alberta	Edmonton	Alberta
Canada	Hopital Charles Lemoyne	Greenfield Park	Quebec
Canada	Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario
Canada	British Columbia Cancer Agency - Centre for the Southern Interior	Kelowna	British Columbia
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	Moncton Hospital	Moncton	New Brunswick
Canada	Hopital Du Sacre-Coeur de Montreal	Montreal	Quebec
Canada	Hopital Notre- Dame du CHUM	Montreal	Quebec
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec
Canada	McGill Cancer Centre at McGill University	Montreal	Quebec
Canada	Nanaimo Cancer Clinic at Nanaimo Regional General Hospital	Nanaimo	British Columbia
Canada	Lions Gate Hospital	North Vancouver	British Columbia
Canada	Ottawa Hospital Regional Cancer Centre - General Campus	Ottawa	Ontario
Canada	Hopital du Saint-Sacrement, Quebec	Quebec City	Quebec
Canada	Allan Blair Cancer Centre at Pasqua Hospital	Regina	Saskatchewan
Canada	Hotel Dieu Health Sciences Hospital - Niagara	St. Catharines	Ontario
Canada	Newfoundland Cancer Treatment and Research Foundation	St. Johns	Newfoundland and Labrador
Canada	Northeastern Ontario Regional Cancer Centre	Sudbury	Ontario
Canada	Fraser Valley Cancer Centre at British Columbia Cancer Agency	Surrey	British Columbia
Canada	Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	St. Joseph's Health Centre - Toronto	Toronto	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre	Toronto	Ontario
Canada	British Columbia Cancer Agency - Vancouver Cancer Centre	Vancouver	British Columbia
Canada	Humber River Regional Hospital - Weston	Weston	Ontario
Canada	Windsor Regional Cancer Centre at Windsor Regional Hospital	Windsor	Ontario
Canada	CancerCare Manitoba	Winnipeg	Manitoba
Denmark	Rigshospitalet - Copenhagen University Hospital	Copenhagen
Denmark	Vejle Sygehus	Vejle
Egypt	National Cancer Institute of Egypt	Cairo
France	Institut Bergonie	Bordeaux
France	Institut Gustave Roussy	Villejuif
Hungary	National Institute of Oncology	Budapest
Italy	Centro di Riferimento Oncologico - Aviano	Aviano
Netherlands	Hagaziekenhuis	's-Gravenhage
Netherlands	Jeroen Bosch Ziekenhuis	's-Hertogenbosch
Netherlands	Medisch Centrum Alkmaar	Alkmaar
Netherlands	Ijselmeer Ziekenhuis - Zuiderzeeziekenhuis	Almere
Netherlands	Meander Medisch Centrum	Amersfont
Netherlands	Academisch Medisch Centrum at University of Amsterdam	Amsterdam
Netherlands	Albert Schweitzerziekenhuis- Zwijndrecht	Amsterdam
Netherlands	Boveny Ziekenhuis	Amsterdam
Netherlands	Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Scheperziekenhuis	Amsterdam
Netherlands	Slotervaart Ziekenhuis	Amsterdam
Netherlands	St. Lucas - Andreas Ziekenhuis	Amsterdam
Netherlands	Vrije Universiteit Medisch Centrum	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	Red Cross Hospital	Den Haag
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	Martini Ziekenhuis	Groningen
Netherlands	University Medical Center Groningen	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	Diaconessenhuis Leiden	Leiden
Netherlands	Leiden University Medical Center	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	Havenziekenhiuis	Rotterdam
Netherlands	Ikazia Ziekenhuis	Rotterdam
Netherlands	Medisch Centrum Rynmond Zuid - Lokatie: Clara	Rotterdam
Netherlands	Medisch Centrum Rynmond-Zuid - Lokatie Zuider	Rotterdam
Netherlands	St. Franciscus Gasthuis	Rotterdam
Netherlands	University Medical Center Rotterdam at Erasmus Medical Center	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	Rivierenland Tiel	Tiel
Netherlands	St. Elisabeth Ziekenhuis	Tilburg
Netherlands	Twee Steden Ziekenhuis Vestiging Tilburg	Tilburg
Netherlands	Mesos Medisch Centrum - Overvecht	Utrecht
Netherlands	Oudenrijn Ziekenhuis	Utrecht
Netherlands	University Medical Center Utrecht	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
New Zealand	University of Auckland School of Medicine	Auckland
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Waikato Hospital	Hamilton
Norway	Haukeland Hospital - University of Bergen	Bergen
Norway	Norwegian Radium Hospital	Oslo
Norway	St. Olavs University Hospital	Trondheim
Poland	Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology	Warsaw
Portugal	Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.	Lisbon
Slovakia	National Cancer Institute - Bratislava	Bratislava
Slovenia	Institute of Oncology - Ljubljana	Ljubljana
South Africa	Mary Potter Oncology Centre	Brooklyn Square
South Africa	Medical Oncology Centre of Rosebank	Johannesburg
South Africa	Sandton Oncology Centre	Johannesburg
South Africa	Johannesburg General Hospital	Parktown
Sweden	Sahlgrenska University Hospital at Gothenburg University	Gothenburg (Goteborg)
Sweden	University Hospital of Linkoping	Linkoping
Sweden	Sunderby Hospital	Lulea
Sweden	Lund University Hospital	Lund
Sweden	Orebro University Hospital	Orebro
Sweden	Karolinska University Hospital - Huddinge	Stockholm
Sweden	Sundsvall Hospital	Sundsvall
Sweden	Umea Universitet	Umea
United Kingdom	Stoke Mandeville Hospital	Aylesbury-Buckinghamshire	England
United Kingdom	Royal United Hospital	Bath	England
United Kingdom	Belfast City Hospital Trust	Belfast	Northern Ireland
United Kingdom	Birmingham Heartlands Hospital	Birmingham	England
United Kingdom	City Hospital - Birmingham	Birmingham	England
United Kingdom	Blackpool Victoria Hospital	Blackpool	England
United Kingdom	Royal Bournemouth Hospital	Bournemouth	England
United Kingdom	Bradford Hospitals NHS Trust	Bradford	England
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	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	University Hospital of Wales	Cardiff	Wales
United Kingdom	Velindre Cancer Center at Velinde Hospital	Cardiff	Wales
United Kingdom	St Helier Hospital	Carshalton	England
United Kingdom	Cheltenham General Hospital	Cheltenham	England
United Kingdom	Countess of Chester Hospital	Chester	England
United Kingdom	Saint Richards Hospital	Chichester
United Kingdom	Essex County Hospital	Colchester	England
United Kingdom	Doncaster Royal Infirmary	Doncaster	England
United Kingdom	Russells Hall Hospital	Dudley	England
United Kingdom	Western General Hospital	Edinburgh	Scotland
United Kingdom	Royal Devon and Exeter Hospital	Exeter	England
United Kingdom	Queen Elizabeth Hospital	Gateshead	England
United Kingdom	Royal Infirmary - Castle	Glasgow	Scotland
United Kingdom	Southern General Hospital	Glasgow	Scotland
United Kingdom	Western Infirmary	Glasgow	Scotland
United Kingdom	Diana Princess of Wales Hospital	Grimsby	England
United Kingdom	Royal Free and University College Medical School	Hampstead, London	England
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	Hinchingbrooke Hospital	Huntingdon	England
United Kingdom	King George Hospital	Ilford, Essex	England
United Kingdom	Kettering General Hosptial	Kettering, Northants
United Kingdom	Leeds General Infirmary at Leeds Teaching Hospital NHS Trust	Leeds	England
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Aintree University Hospital	Liverpool	England
United Kingdom	Royal Liverpool University Hospital	Liverpool	England
United Kingdom	Guy's and St. Thomas' Hospitals NHS Foundation Trust	London	England
United Kingdom	Royal Marsden NHS Foundation Trust - London	London	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	St. George's Hospital	London	England
United Kingdom	St. Georges Hospital Medical School	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	Royal Gwent Hospital	Newport Gwent	Wales
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	Glan Clywd District General Hospital	Rhyl, Denbighshire	Wales
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	Staffordshire General Hospital	Stafford
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	Great Western Hospital	Swindon,
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

Sponsors (6)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC	Australasian Leukaemia and Lymphoma Group, Lymphoma Trials Office, NCIC Clinical Trials Group, Nordic Lymphoma Group, Stichting Hemato-Oncologie voor Volwassenen Nederland

Countries where clinical trial is conducted

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

References & Publications (6)

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. — View Citation

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. Epub 2002 Oct 17. — View Citation

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 — View Citation

van Oers MH, Tönnissen 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 — View Citation

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 pha — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to treatment
Secondary	Overall survival		from randomization
Secondary	Progression Free survival		from randomization