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

NCT00004179 | Completed Phase 3

• 6 other identifiers: EORTC-20981ALLG-NHLLOW4BNLI-EORTC-20981HOVON-H039CAN-NCIC-LY7NORDIC-EORTC-20981
• Study Type: interventional
• Target: 475
• Locations: 17 countries
• Sites: 260

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.

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

Outcome Measures

Primary Outcomes (1)

• Response to treatment

Secondary Outcomes (2)

• Overall survival

  from randomization

• Progression Free survival

  from randomization

Interventions

rituximab BIOLOGICAL

CHOP regimen DRUG

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

prednisone DRUG

vincristine sulfate DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• Lymphoma Trials Office: collaborator
• Stichting Hemato-Oncologie voor Volwassenen Nederland: collaborator
• Australasian Leukaemia and Lymphoma Group: collaborator
• NCIC Clinical Trials Group: collaborator
• Nordic Lymphoma Group: collaborator

Study Sites (261)

Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

Location

Cancer Therapy Centre at Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Institute of Oncology at Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Prince of Wales Private Hospital

Randwick, New South Wales, NSW 2031, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

St. Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Sydney Cancer Centre at Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

St. George Hospital and Community Health Service

Sydney, New South Wales, 2217, Australia

Location

Westmead Breast Centre at NSW Breast Cancer Institute

Westmead, New South Wales, 2145, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Wollongong Hospital

Wollongong, New South Wales, 2500, Australia

Location

Wesley Medical Centre

Auchenflower, Queensland, 4066, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Greenslopes Private Hospital

Greenslopes, Queensland, 4120, Australia

Location

Townsville General Hospital

Townsville, Queensland, 4810, Australia

Location

Royal Adelaide Hospital Cancer Centre

Adelaide, South Australia, 5000, Australia

Location

Ashford Cancer Centre

Ashford, South Australia, 5035, Australia

Location

Flinder Medical Centres

Bedford Park, South Australia, 5042, Australia

Location

Queen Elizabeth Hospital

Woodville, South Australia, 5011, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

St. John of God Hospital

Ballarat, Victoria, 3350, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

John Fawkner Hospital

Coburg, Victoria, 3058, Australia

Location

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 8006, Australia

Location

St. Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

Frankston Hospital

Frankston, Victoria, 3199, Australia

Location

Geelong Hospital

Geelong, Victoria, 3200, Australia

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3181, Australia

Location

Garden Consulting Rooms

Mornington, Victoria, 3931, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Fremantle Hospital

Fremantle, Western Australia, 6160, Australia

Location

Mount Medical Centre

Perth, Western Australia, 6000, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Sir Charles Gairdner Hospital - Perth

Perth, Western Australia, 6009, Australia

Location

Ziekenhuis Netwerk Antwerpen Middelheim

Antwerp, 2020, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

Algemeen Ziekenhuis Sint Lucas

Ghent, B-9000, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

H. Hartziekenhuis - Roeselaere.

Roeselare, 8800, Belgium

Location

Algemeen Ziekenhuis Sint-Augustinus

Wilrijk, 2610, Belgium

Location

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Nanaimo Cancer Clinic at Nanaimo Regional General Hospital

Nanaimo, British Columbia, V9S 2B7, Canada

Location

Lions Gate Hospital

North Vancouver, British Columbia, V7L 2P9, Canada

Location

Fraser Valley Cancer Centre at British Columbia Cancer Agency

Surrey, British Columbia, V3V 1Z2, Canada

Location

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Moncton Hospital

Moncton, New Brunswick, E1C 6ZB, Canada

Location

Newfoundland Cancer Treatment and Research Foundation

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

Location

Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Royal Victoria Hospital of Barrie

Barrie, Ontario, L4M 6M2, Canada

Location

Northeastern Ontario Regional Cancer Centre

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, K7L 5P9, Canada

Location

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Trillium Health Centre - Mississauga Site

Mississauga, Ontario, L5B 1B8, Canada

Location

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, K1H 1C4, Canada

Location

Hotel Dieu Health Sciences Hospital - Niagara

St. Catharines, Ontario, L2R 5K3, Canada

Location

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

Thunder Bay, Ontario, P7A 7T1, Canada

Location

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

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

St. Joseph's Health Centre - Toronto

Toronto, Ontario, M6R 1B5, Canada

Location

Humber River Regional Hospital - Weston

Weston, Ontario, M9N 1N8, Canada

Location

Windsor Regional Cancer Centre at Windsor Regional Hospital

Windsor, Ontario, N8W 2X3, Canada

Location

Hopital Charles Lemoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

McGill Cancer Centre at McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Hopital Du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Hopital Notre- Dame du CHUM

Montreal, Quebec, H4L 2M1, Canada

Location

Hopital du Saint-Sacrement, Quebec

Québec, Quebec, G1S 4L8, Canada

Location

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, S4T 7T1, Canada

Location

Rigshospitalet - Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Vejle Sygehus

Vejle, 7100, Denmark

Location

National Cancer Institute of Egypt

Cairo, Egypt

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

National Institute of Oncology

Budapest, 1125, Hungary

Location

Centro di Riferimento Oncologico - Aviano

Aviano, 33081, Italy

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5211 NL, Netherlands

Location

Medisch Centrum Alkmaar

Alkmaar, 1815 JD, Netherlands

Location

Ijselmeer Ziekenhuis - Zuiderzeeziekenhuis

Almere Stad, 1315RA, Netherlands

Location

Meander Medisch Centrum

Amersfont, 3016 CP, Netherlands

Location

St. Lucas - Andreas Ziekenhuis

Amsterdam, 1006 AE, Netherlands

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1007 MB, Netherlands

Location

Boveny Ziekenhuis

Amsterdam, 1034 CS, Netherlands

Location

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

Location

Slotervaart Ziekenhuis

Amsterdam, 1066 EC, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Albert Schweitzerziekenhuis- Zwijndrecht

Amsterdam, Netherlands

Location

Scheperziekenhuis

Amsterdam, Netherlands

Location

Gelre Ziekenhuizen - Lokatie Lukas

Apeldoorn, 7334 DZ, Netherlands

Location

Ziekenhuis Lievensberg

Bergen op Zoom, 4624 VT, Netherlands

Location

Streekziekenhuis Gooi-Noord

Blaricum, 1261 AN, Netherlands

Location

Amphia Ziekenhuis - locatie Langendijk

Breda, 4800 RL, Netherlands

Location

Amphia Ziekenhuis - locatie Molengracht

Breda, 4818 CK, Netherlands

Location

Atrium Medical Centre - Brunssum

Brunssum, 6442 BE, Netherlands

Location

Ijsselland Ziekenhuis

Capelle aan den IJssel, 2906 ZC, Netherlands

Location

Reinier de Graaf Group - Delft

Delft, NL 2600 GA, Netherlands

Location

Gemini Ziekenhuis

Den Helder, 1782 GZ, Netherlands

Location

Deventer Ziekenhuisen

Deventer, 7415 CM, Netherlands

Location

Van Weel Bethesda Ziekenhuis

Dirksland, 3247 BW, Netherlands

Location

NIJ Smellinghe

Drachten, NL-9200 DA, Netherlands

Location

Diaconessenhuis Eindhoven

Eindhoven, 5631 BM, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7500 KA, Netherlands

Location

St. Anna Ziekenhuis

Geldrop, NL-5664, Netherlands

Location

Beatrixziekenhuis

Gorinchem, Netherlands

Location

Groene Hart Ziekenhuis

Gouda, 2803 HH, Netherlands

Location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Martini Ziekenhuis

Groningen, Netherlands

Location

Kennemer Gasthuis - Locatie EG

Haarlem, 2000, Netherlands

Location

Spaarne Ziekenhuis Haarlem

Haarlem, 2012 CE, Netherlands

Location

Ziekenhuis St Jansdal

Harderwijk, 3840 AC, Netherlands

Location

Tjongerschans Ziekenhuis

Heerenveen, 8440 MA, Netherlands

Location

Atrium Medical Centre - Heerlen

Heerlen, 6419 PC, Netherlands

Location

Elkerliek Ziekenhuis

Helmond, 5707-HA, Netherlands

Location

Streekziekenhuis Midden-Twente

Hengelo, 7555 DL, Netherlands

Location

Westfries Gasthuis

Hoorn, 1624 AR, Netherlands

Location

Zweedse Rode Kruis Ziekenhuis

La Zierikzee, NL-4300, Netherlands

Location

Medisch Centrum Leeuwarden - Zuid

Leeuwarden, 8934 AD, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Diaconessenhuis Leiden

Leiden, 2300 RD, Netherlands

Location

Rijnland Ziekenhuis

Leiderdorp, 2350 CC, Netherlands

Location

Medisch Centrum Haaglanden Antoniushove

Leidschendam, 2262 BA, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

Nederlandse Hervormde Diaconessenhuisinrichting

Meppel, NL-7940, Netherlands

Location

Sint Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Nijmegen Cancer Center at Radboud University Medical Center

Nijmegen, NL-6500 HB, Netherlands

Location

Ziekenhuis Bernhoven

Oss, 5340 BE, Netherlands

Location

Waterlandziekenhuis

Purmerend, 1440 AG, Netherlands

Location

Saint Laurentius Ziekenhuis

Roermond, 6043 CV, Netherlands

Location

Saint Franciscus Ziekenhuis

Roosendaal, 4708 AE, Netherlands

Location

University Medical Center Rotterdam at Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

Location

St. Franciscus Gasthuis

Rotterdam, 3045 PM, Netherlands

Location

Medisch Centrum Rynmond-Zuid - Lokatie Zuider

Rotterdam, 3075 AC, Netherlands

Location

Medisch Centrum Rynmond Zuid - Lokatie: Clara

Rotterdam, 3078 HT, Netherlands

Location

Havenziekenhiuis

Rotterdam, NL-3000, Netherlands

Location

Ikazia Ziekenhuis

Rotterdam, NL-3083, Netherlands

Location

Maasland Hospital

Sittard, 6131 BK, Netherlands

Location

Albert Schweitzerziekenhuis- Sliedrecht

Sliedrecht, NL-336, Netherlands

Location

Ruwaard Van Putten Ziekenhuis

Spykenisse, NL-3200 GA, Netherlands

Location

Ziekenhuis Refaja

Stadskanaal, NL-9501, Netherlands

Location

Ziekenhuis de Honte

Terneuzen, NL-4535, Netherlands

Location

Hagaziekenhuis

The Hague, 2545 CH, Netherlands

Location

Red Cross Hospital

The Hague, 2566 MJ, Netherlands

Location

Rivierenland Tiel

Tiel, NL-4000, Netherlands

Location

St. Elisabeth Ziekenhuis

Tilburg, 5022 GC, Netherlands

Location

Twee Steden Ziekenhuis Vestiging Tilburg

Tilburg, 5042 AD, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Mesos Medisch Centrum - Overvecht

Utrecht, NL-3563, Netherlands

Location

Oudenrijn Ziekenhuis

Utrecht, Netherlands

Location

St. Joseph Veghel

Veghel, NL-5461, Netherlands

Location

Maxima Medisch Centrum - locatie Eindhoven

Veldhoven, 5500 MB, Netherlands

Location

Holy-Ziekenhuis

Vlaardingen, NL-3130 GA, Netherlands

Location

Reinier de Graaf Group - Voorburg

Voorburg, 2275 CX, Netherlands

Location

St. Jans Gasthuis Weert

Weert Be, 6001, Netherlands

Location

Hofpoort Ziekenhuis

Woerden, NL-3445, Netherlands

Location

Zaans Medisch Centrum

Zaandam, 1502 DV, Netherlands

Location

Lorentz Ziekenhuis

Zeist, NL-3700, Netherlands

Location

'T Lange Land Ziekenhuis

Zoetermeer, NL-2700, Netherlands

Location

Isala Klinieken - locatie Sophia

Zwolle, 8000 GK, Netherlands

Location

Isala Klinieken - locatie Weezenlanden

Zwolle, NL-8000 GM, Netherlands

Location

University of Auckland School of Medicine

Auckland, 3, New Zealand

Location

Christchurch Hospital

Christchurch, 1, New Zealand

Location

Waikato Hospital

Hamilton, 2020, New Zealand

Location

Haukeland Hospital - University of Bergen

Bergen, N-5021, Norway

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

St. Olavs University Hospital

Trondheim, 7006, Norway

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, 02-781, Poland

Location

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

Lisbon, 1099-023 Codex, Portugal

Location

National Cancer Institute - Bratislava

Bratislava, 833 10, Slovakia

Location

Institute of Oncology - Ljubljana

Ljubljana, Sl-1000, Slovenia

Location

Mary Potter Oncology Centre

Brooklyn Square, 1577, South Africa

Location

Sandton Oncology Centre

Johannesburg, 2121, South Africa

Location

Medical Oncology Centre of Rosebank

Johannesburg, 2193, South Africa

Location

Johannesburg General Hospital

Parktown, 2193, South Africa

Location

Sahlgrenska University Hospital at Gothenburg University

Gothenburg (Goteborg), S-413 45, Sweden

Location

University Hospital of Linkoping

Linköping, S-581 85, Sweden

Location

Sunderby Hospital

Luleå, 95128, Sweden

Location

Lund University Hospital

Lund, S-22185, Sweden

Location

Orebro University Hospital

Örebro, 70185, Sweden

Location

Karolinska University Hospital - Huddinge

Stockholm, S-141 86, Sweden

Location

Sundsvall Hospital

Sundsvall, 85186, Sweden

Location

Umea Universitet

Umeå, S-901 85, Sweden

Location

Stoke Mandeville Hospital

Aylesbury-Buckinghamshire, England, HP21 8AL, United Kingdom

Location

Royal United Hospital

Bath, England, BA1 3NG, United Kingdom

Location

City Hospital - Birmingham

Birmingham, England, B18 7QH, United Kingdom

Location

Birmingham Heartlands Hospital

Birmingham, England, B9 5SS, United Kingdom

Location

Blackpool Victoria Hospital

Blackpool, England, FY3 8NR, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, England, BH7 7DW, United Kingdom

Location

Bradford Hospitals NHS Trust

Bradford, England, BD9 6RJ, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

Conquest Hospital

Canterbury, England, CT2 7NR, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, England, CT2 7NR, United Kingdom

Location

St Helier Hospital

Carshalton, England, SM5 1AA, United Kingdom

Location

Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

Location

Countess of Chester Hospital

Chester, England, CH2 1UL, United Kingdom

Location

Essex County Hospital

Colchester, England, C03 3NB, United Kingdom

Location

Doncaster Royal Infirmary

Doncaster, England, DN2 5LT, United Kingdom

Location

Russells Hall Hospital

Dudley, England, DY1 2HQ, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Queen Elizabeth Hospital

Gateshead, England, NE9 6SX, United Kingdom

Location

Diana Princess of Wales Hospital

Grimsby, England, DN33 2BA, United Kingdom

Location

Royal Free and University College Medical School

Hampstead, London, England, NW3 2QG, United Kingdom

Location

Hinchingbrooke Hospital

Huntingdon, England, PE18 6NT, United Kingdom

Location

King George Hospital

Ilford, Essex, England, IG3 8YB, United Kingdom

Location

Leeds General Infirmary at Leeds Teaching Hospital NHS Trust

Leeds, England, LS1 3EX, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, England, L69 3GA, United Kingdom

Location

Aintree University Hospital

Liverpool, England, L9 7AL, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

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

London, England, SE1 9RT, United Kingdom

Location

St. George's Hospital

London, England, SW17 0QT, United Kingdom

Location

St. Georges Hospital Medical School

London, England, SW17 ORE, United Kingdom

Location

Royal Marsden NHS Foundation Trust - London

London, England, SW3 6JJ, United Kingdom

Location

University College Hospital

London, England, WC1E 6AU, United Kingdom

Location

Clatterbridge Centre for Oncology NHS Trust

Merseyside, England, CH63 4JY, United Kingdom

Location

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

Location

Newcastle Upon Tyne Hospitals NHS Trust

Newcastle upon Tyne, England, NE7 7DN, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, England, NR1 3SR, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Portsmouth Hospitals NHS Trust

Portsmouth, England, P03 6AD, United Kingdom

Location

Whiston Hospital

Prescot Merseyside, England, L35 5DR, United Kingdom

Location

Royal Preston Hospital

Preston, England, PR2 9HT, United Kingdom

Location

Berkshire Cancer Centre at Royal Berkshire Hospital

Reading, England, RG1 5AN, United Kingdom

Location

Oldchurch Hospital

Romford, England, RM7 OBE, United Kingdom

Location

Pembury Hospital

Royal Tunbridge Wells, Kent, England, TN2 4QJ, United Kingdom

Location

Salisbury District Hospital

Salisbury, England, SP2 8BJ, United Kingdom

Location

Scunthorpe General Hospital

Scunthorpe, England, DN15 7BH, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

North Staffs Royal Infirmary

Stoke-on-Trent, England, ST4 7LN, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Singleton Hospital

Swansea, England, SA 2 8QA, United Kingdom

Location

Taunton and Somerset Hospital

Taunton Somerset, England, TA1 5DA, United Kingdom

Location

Torbay Hospital

Torquay Devon, England, TQ2 7AA, United Kingdom

Location

Hillingdon Hospital

Uxbridge, England, UB8 3NN, United Kingdom

Location

Sandwell General Hospital

West Bromwich, England, B71 4HJ, United Kingdom

Location

Royal Hampshire County Hospital

Winchester, England, SO22 5DG, United Kingdom

Location

New Cross Hospital

Wolverhampton, England, WV10 0QP, United Kingdom

Location

Belfast City Hospital Trust

Belfast, Northern Ireland, BT9 7AB, United Kingdom

Location

Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Western Infirmary

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Royal Infirmary - Castle

Glasgow, Scotland, G4 0SF, United Kingdom

Location

Southern General Hospital

Glasgow, Scotland, G51 4TF, United Kingdom

Location

Velindre Cancer Center at Velinde Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

University Hospital of Wales

Cardiff, Wales, CF14 4XN, United Kingdom

Location

Royal Gwent Hospital

Newport Gwent, Wales, NP9 2UB, United Kingdom

Location

Glan Clywd District General Hospital

Rhyl, Denbighshire, Wales, LL 18 5UJ, United Kingdom

Location

Saint Richards Hospital

Chichester, P019 4SE, United Kingdom

Location

Hull Royal Infirmary

Hull, HU3 2KZ, United Kingdom

Location

Kettering General Hosptial

Kettering, Northants, NNI6 8UZ, United Kingdom

Location

Staffordshire General Hospital

Stafford, ST16 3SA, United Kingdom

Location

Great Western Hospital

Swindon, SN1 4JU, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 20014875 BACKGROUND

• 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.

  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.

  PMID: 12424535 BACKGROUND

• 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.

  PMID: 20368567 RESULT

• 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.

  PMID: 20439641 RESULT

• 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.

  PMID: 16873669 RESULT

• 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.

  PMID: 34384709 DERIVED

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular

Interventions

Rituximab; VAP-cyclo protocol; Cyclophosphamide; Doxorubicin; Prednisone; Vincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• M. H. J. Van Oers, MD

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

  STUDY CHAIR

• Robert Marcus, MD

  Cambridge University Hospitals NHS Foundation Trust

  STUDY CHAIR

• Max M. Wolf, MD

  Peter MacCallum Cancer Centre, Australia

  STUDY CHAIR

• Richard J. Klasa, MD

  British Columbia Cancer Agency

  STUDY CHAIR

• Eva K. Kimby, MD, PhD

  Karolinska Institutet

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2000
• First Posted: January 27, 2003
• Study Start: May 1, 1999
• Primary Completion: April 1, 2004
• Study Completion: July 19, 2017
• Last Updated: February 15, 2021

Record last verified: 2021-02

Locations

FR (2); NO (3); AU (37); HU (1); PT (1); EG (1); SL (1); ZA (4); SE (8); PL (1); NZ (3); NL (84); IT (1); GB (72); BE (7); DK (2); CA (32)