Clinical trial NCT00004179: Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
Collaborators: name: Lymphoma Trials Office
name: Stichting Hemato-Oncologie voor Volwassenen Nederland
name: Australasian Leukaemia and Lymphoma Group
name: NCIC Clinical Trials Group
name: Nordic Lymphoma Group
First posted: 2003-01-27
Enrollment: 475
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Response to treatment
Secondary outcomes:
measure: Overall survival
timeFrame: from randomization
measure: Progression Free survival
timeFrame: from randomization
Other outcomes:
Locations:
city: Garran
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Cancer Therapy Centre at Liverpool Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Institute of Oncology at Prince of Wales Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Private Hospital
state: New South Wales
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Sydney
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Cancer Centre at Royal Prince Alfred Hospital
state: New South Wales
city: Sydney
country: Australia
facility: St. George Hospital and Community Health Service
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Breast Centre at NSW Breast Cancer Institute
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital
state: New South Wales
city: Auchenflower
country: Australia
facility: Wesley Medical Centre
state: Queensland
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Greenslopes
country: Australia
facility: Greenslopes Private Hospital
state: Queensland
city: Townsville
country: Australia
facility: Townsville General Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital Cancer Centre
state: South Australia
city: Ashford
country: Australia
facility: Ashford Cancer Centre
state: South Australia
city: Bedford Park
country: Australia
facility: Flinder Medical Centres
state: South Australia
city: Woodville
country: Australia
facility: Queen Elizabeth Hospital
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Ballarat
country: Australia
facility: St. John of God Hospital
state: Victoria
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Coburg
country: Australia
facility: John Fawkner Hospital
state: Victoria
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital
state: Victoria
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
city: Geelong
country: Australia
facility: Geelong Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Mornington
country: Australia
facility: Garden Consulting Rooms
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
city: Perth
country: Australia
facility: Mount Medical Centre
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital - Perth
state: Western Australia
city: Antwerp
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen Middelheim
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Ghent
country: Belgium
facility: Algemeen Ziekenhuis Sint Lucas
city: Leuven
country: Belgium
facility: U.Z. Gasthuisberg
city: Roeselare
country: Belgium
facility: H. Hartziekenhuis - Roeselaere.
city: Wilrijk
country: Belgium
facility: Algemeen Ziekenhuis Sint-Augustinus
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre - Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute at University of Alberta
state: Alberta
city: Kelowna
country: Canada
facility: British Columbia Cancer Agency - Centre for the Southern Interior
state: British Columbia
city: Nanaimo
country: Canada
facility: Nanaimo Cancer Clinic at Nanaimo Regional General Hospital
state: British Columbia
city: North Vancouver
country: Canada
facility: Lions Gate Hospital
state: British Columbia
city: Surrey
country: Canada
facility: Fraser Valley Cancer Centre at British Columbia Cancer Agency
state: British Columbia
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency - Vancouver Cancer Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Moncton
country: Canada
facility: Moncton Hospital
state: New Brunswick
city: St. Johns
country: Canada
facility: Newfoundland Cancer Treatment and Research Foundation
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Barrie
country: Canada
facility: Royal Victoria Hospital of Barrie
state: Ontario
city: Hamilton
country: Canada
facility: Margaret and Charles Juravinski Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program at London Health Sciences Centre
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Centre - Mississauga Site
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Regional Cancer Centre - General Campus
state: Ontario
city: St. Catharines
country: Canada
facility: Hotel Dieu Health Sciences Hospital - Niagara
state: Ontario
city: Sudbury
country: Canada
facility: Northeastern Ontario Regional Cancer Centre
state: Ontario
city: Thunder Bay
country: Canada
facility: Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Joseph's Health Centre - Toronto
state: Ontario
city: Weston
country: Canada
facility: Humber River Regional Hospital - Weston
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Cancer Centre at Windsor Regional Hospital
state: Ontario
city: Greenfield Park
country: Canada
facility: Hopital Charles Lemoyne
state: Quebec
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
city: Montreal
country: Canada
facility: McGill Cancer Centre at McGill University
state: Quebec
city: Montreal
country: Canada
facility: Hopital Du Sacre-Coeur de Montreal
state: Quebec
city: Montreal
country: Canada
facility: Hopital Notre- Dame du CHUM
state: Quebec
city: Quebec City
country: Canada
facility: Hopital du Saint-Sacrement, Quebec
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre at Pasqua Hospital
state: Saskatchewan
city: Copenhagen
country: Denmark
facility: Rigshospitalet - Copenhagen University Hospital
city: Vejle
country: Denmark
facility: Vejle Sygehus
city: Cairo
country: Egypt
facility: National Cancer Institute of Egypt
city: Bordeaux
country: France
facility: Institut Bergonie
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Budapest
country: Hungary
facility: National Institute of Oncology
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - Aviano
city: 's-Gravenhage
country: Netherlands
facility: Hagaziekenhuis
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Almere
country: Netherlands
facility: Ijselmeer Ziekenhuis - Zuiderzeeziekenhuis
city: Amersfont
country: Netherlands
facility: Meander Medisch Centrum
city: Amsterdam
country: Netherlands
facility: St. Lucas - Andreas Ziekenhuis
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum
city: Amsterdam
country: Netherlands
facility: Boveny Ziekenhuis
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
city: Amsterdam
country: Netherlands
facility: Slotervaart Ziekenhuis
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum at University of Amsterdam
city: Amsterdam
country: Netherlands
facility: Albert Schweitzerziekenhuis- Zwijndrecht
city: Amsterdam
country: Netherlands
facility: Scheperziekenhuis
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen - Lokatie Lukas
city: Bergen-op-Zoom
country: Netherlands
facility: Ziekenhuis Lievensberg
city: Blaricum
country: Netherlands
facility: Streekziekenhuis Gooi-Noord
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis - locatie Langendijk
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis - locatie Molengracht
city: Brunssum
country: Netherlands
facility: Atrium Medical Centre - Brunssum
city: Capelle aan den Ijssel
country: Netherlands
facility: Ijsselland Ziekenhuis
city: Delft
country: Netherlands
facility: Reinier de Graaf Group - Delft
city: Den Haag
country: Netherlands
facility: Red Cross Hospital
city: Den Helder
country: Netherlands
facility: Gemini Ziekenhuis
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuisen
city: Dirksland
country: Netherlands
facility: Van Weel Bethesda Ziekenhuis
city: Drachten
country: Netherlands
facility: NIJ Smellinghe
city: Eindhoven
country: Netherlands
facility: Diaconessenhuis Eindhoven
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Geldrop
country: Netherlands
facility: St. Anna Ziekenhuis
city: Gorinchem
country: Netherlands
facility: Beatrixziekenhuis
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Haarlem
country: Netherlands
facility: Kennemer Gasthuis - Locatie EG
city: Haarlem
country: Netherlands
facility: Spaarne Ziekenhuis Haarlem
city: Harderwijk
country: Netherlands
facility: Ziekenhuis St Jansdal
city: Heerenveen
country: Netherlands
facility: Tjongerschans Ziekenhuis
city: Heerlen
country: Netherlands
facility: Atrium Medical Centre - Heerlen
city: Helmond
country: Netherlands
facility: Elkerliek Ziekenhuis
city: Hengelo
country: Netherlands
facility: Streekziekenhuis Midden-Twente
city: Hoorn
country: Netherlands
facility: Westfries Gasthuis
city: La Zierikzee
country: Netherlands
facility: Zweedse Rode Kruis Ziekenhuis
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden - Zuid
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Leiden
country: Netherlands
facility: Diaconessenhuis Leiden
city: Leiderdorp
country: Netherlands
facility: Rijnland Ziekenhuis
city: Leidschendam
country: Netherlands
facility: Medisch Centrum Haaglanden Antoniushove
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Meppel
country: Netherlands
facility: Nederlandse Hervormde Diaconessenhuisinrichting
city: Nieuwegein
country: Netherlands
facility: Sint Antonius Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Nijmegen Cancer Center at Radboud University Medical Center
city: Oss
country: Netherlands
facility: Ziekenhuis Bernhoven
city: Purmerend
country: Netherlands
facility: Waterlandziekenhuis
city: Roermond
country: Netherlands
facility: Saint Laurentius Ziekenhuis
city: Roosendaal
country: Netherlands
facility: Saint Franciscus Ziekenhuis
city: Rotterdam
country: Netherlands
facility: University Medical Center Rotterdam at Erasmus Medical Center
city: Rotterdam
country: Netherlands
facility: St. Franciscus Gasthuis
city: Rotterdam
country: Netherlands
facility: Medisch Centrum Rynmond-Zuid - Lokatie Zuider
city: Rotterdam
country: Netherlands
facility: Medisch Centrum Rynmond Zuid - Lokatie: Clara
city: Rotterdam
country: Netherlands
facility: Havenziekenhiuis
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis
city: Sittard
country: Netherlands
facility: Maasland Hospital
city: Sliedrecht
country: Netherlands
facility: Albert Schweitzerziekenhuis- Sliedrecht
city: Spykenisse
country: Netherlands
facility: Ruwaard Van Putten Ziekenhuis
city: Stadskanaal
country: Netherlands
facility: Ziekenhuis Refaja
city: Terneuzen
country: Netherlands
facility: Ziekenhuis de Honte
city: Tiel
country: Netherlands
facility: Rivierenland Tiel
city: Tilburg
country: Netherlands
facility: St. Elisabeth Ziekenhuis
city: Tilburg
country: Netherlands
facility: Twee Steden Ziekenhuis Vestiging Tilburg
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Utrecht
country: Netherlands
facility: Mesos Medisch Centrum - Overvecht
city: Utrecht
country: Netherlands
facility: Oudenrijn Ziekenhuis
city: Veghel
country: Netherlands
facility: St. Joseph Veghel
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum - locatie Eindhoven
city: Vlaardingen
country: Netherlands
facility: Holy-Ziekenhuis
city: Voorburg
country: Netherlands
facility: Reinier de Graaf Group - Voorburg
city: Weert Be
country: Netherlands
facility: St. Jans Gasthuis Weert
city: Woerden
country: Netherlands
facility: Hofpoort Ziekenhuis
city: Zaandam
country: Netherlands
facility: Zaans Medisch Centrum
city: Zeist
country: Netherlands
facility: Lorentz Ziekenhuis
city: Zoetermeer
country: Netherlands
facility: 'T Lange Land Ziekenhuis
city: Zwolle
country: Netherlands
facility: Isala Klinieken - locatie Sophia
city: Zwolle
country: Netherlands
facility: Isala Klinieken - locatie Weezenlanden
city: Auckland
country: New Zealand
facility: University of Auckland School of Medicine
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Bergen
country: Norway
facility: Haukeland Hospital - University of Bergen
city: Oslo
country: Norway
facility: Norwegian Radium Hospital
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
city: Lisbon
country: Portugal
facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.
city: Bratislava
country: Slovakia
facility: National Cancer Institute - Bratislava
city: Ljubljana
country: Slovenia
facility: Institute of Oncology - Ljubljana
city: Brooklyn Square
country: South Africa
facility: Mary Potter Oncology Centre
city: Johannesburg
country: South Africa
facility: Sandton Oncology Centre
city: Johannesburg
country: South Africa
facility: Medical Oncology Centre of Rosebank
city: Parktown
country: South Africa
facility: Johannesburg General Hospital
city: Gothenburg (Goteborg)
country: Sweden
facility: Sahlgrenska University Hospital at Gothenburg University
city: Linkoping
country: Sweden
facility: University Hospital of Linkoping
city: Lulea
country: Sweden
facility: Sunderby Hospital
city: Lund
country: Sweden
facility: Lund University Hospital
city: Orebro
country: Sweden
facility: Orebro University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital - Huddinge
city: Sundsvall
country: Sweden
facility: Sundsvall Hospital
city: Umea
country: Sweden
facility: Umea Universitet
city: Aylesbury-Buckinghamshire
country: United Kingdom
facility: Stoke Mandeville Hospital
state: England
city: Bath
country: United Kingdom
facility: Royal United Hospital
state: England
city: Birmingham
country: United Kingdom
facility: City Hospital - Birmingham
state: England
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
state: England
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
state: England
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
state: England
city: Bradford
country: United Kingdom
facility: Bradford Hospitals NHS Trust
state: England
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
state: England
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
state: England
city: Canterbury
country: United Kingdom
facility: Conquest Hospital
state: England
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
state: England
city: Carshalton
country: United Kingdom
facility: St Helier Hospital
state: England
city: Cheltenham
country: United Kingdom
facility: Cheltenham General Hospital
state: England
city: Chester
country: United Kingdom
facility: Countess of Chester Hospital
state: England
city: Colchester
country: United Kingdom
facility: Essex County Hospital
state: England
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary
state: England
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
state: England
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
state: England
city: Gateshead
country: United Kingdom
facility: Queen Elizabeth Hospital
state: England
city: Grimsby
country: United Kingdom
facility: Diana Princess of Wales Hospital
state: England
city: Hampstead, London
country: United Kingdom
facility: Royal Free and University College Medical School
state: England
city: Huntingdon
country: United Kingdom
facility: Hinchingbrooke Hospital
state: England
city: Ilford, Essex
country: United Kingdom
facility: King George Hospital
state: England
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary at Leeds Teaching Hospital NHS Trust
state: England
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
state: England
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
state: England
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital
state: England
city: London
country: United Kingdom
facility: Saint Bartholomew's Hospital
state: England
city: London
country: United Kingdom
facility: Guy's and St. Thomas' Hospitals NHS Foundation Trust
state: England
city: London
country: United Kingdom
facility: St. George's Hospital
state: England
city: London
country: United Kingdom
facility: St. Georges Hospital Medical School
state: England
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust - London
state: England
city: London
country: United Kingdom
facility: University College Hospital
state: England
city: Merseyside
country: United Kingdom
facility: Clatterbridge Centre for Oncology NHS Trust
state: England
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
state: England
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Newcastle Upon Tyne Hospitals NHS Trust
state: England
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre at Mount Vernon Hospital
state: England
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: England
city: Oxford
country: United Kingdom
facility: Oxford Radcliffe Hospital
state: England
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust
state: England
city: Prescot Merseyside
country: United Kingdom
facility: Whiston Hospital
state: England
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
state: England
city: Reading
country: United Kingdom
facility: Berkshire Cancer Centre at Royal Berkshire Hospital
state: England
city: Romford
country: United Kingdom
facility: Oldchurch Hospital
state: England
city: Royal Tunbridge Wells, Kent
country: United Kingdom
facility: Pembury Hospital
state: England
city: Salisbury
country: United Kingdom
facility: Salisbury District Hospital
state: England
city: Scunthorpe
country: United Kingdom
facility: Scunthorpe General Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Cancer Research Centre at Weston Park Hospital
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: England
city: Stoke-On-Trent
country: United Kingdom
facility: North Staffs Royal Infirmary
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust - Surrey
state: England
city: Swansea
country: United Kingdom
facility: Singleton Hospital
state: England
city: Taunton Somerset
country: United Kingdom
facility: Taunton and Somerset Hospital
state: England
city: Torquay Devon
country: United Kingdom
facility: Torbay Hospital
state: England
city: Uxbridge
country: United Kingdom
facility: Hillingdon Hospital
state: England
city: West Bromwich
country: United Kingdom
facility: Sandwell General Hospital
state: England
city: Winchester
country: United Kingdom
facility: Royal Hampshire County Hospital
state: England
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
state: England
city: Belfast
country: United Kingdom
facility: Belfast City Hospital Trust
state: Northern Ireland
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
state: Scotland
city: Glasgow
country: United Kingdom
facility: Western Infirmary
state: Scotland
city: Glasgow
country: United Kingdom
facility: Royal Infirmary - Castle
state: Scotland
city: Glasgow
country: United Kingdom
facility: Southern General Hospital
state: Scotland
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Center at Velinde Hospital
state: Wales
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
state: Wales
city: Newport Gwent
country: United Kingdom
facility: Royal Gwent Hospital
state: Wales
city: Rhyl, Denbighshire
country: United Kingdom
facility: Glan Clywd District General Hospital
state: Wales
city: Chichester
country: United Kingdom
facility: Saint Richards Hospital
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: Kettering, Northants
country: United Kingdom
facility: Kettering General Hosptial
city: Stafford
country: United Kingdom
facility: Staffordshire General Hospital
city: Swindon,
country: United Kingdom
facility: Great Western Hospital
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: M. H. J. Van Oers, MD
role: STUDY_CHAIR
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: Robert Marcus, MD
role: STUDY_CHAIR
affiliation: Peter MacCallum Cancer Centre, Australia
name: Max M. Wolf, MD
role: STUDY_CHAIR
affiliation: British Columbia Cancer Agency
name: Richard J. Klasa, MD
role: STUDY_CHAIR
affiliation: Karolinska Institutet
name: Eva K. Kimby, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
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.
citation: 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.
citation: 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.
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 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.
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 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.
citation: 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.