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Spots Global Cancer Trial Database for Combination Chemotherapy Plus Peripheral Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

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Trial Identification

Brief Title: Combination Chemotherapy Plus Peripheral Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

Official Title: Randomized Study of Rituximab (Mabthera) in Patients With Relapsed Follicular Lymphoma Prior to High-Dose Therapy as In Vivo Purging and to Maintain Remission Following High-Dose Therapy

Study ID: NCT00005589

Conditions

Lymphoma

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. 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 if combination chemotherapy plus peripheral stem cell transplantation is more effective with or without rituximab for non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying giving combination chemotherapy and peripheral stem cell transplantation together with rituximab to see how well it works compared to combination chemotherapy and peripheral stem cell transplantation alone in treating patients with relapsed non-Hodgkin's lymphoma.

Detailed Description: OBJECTIVES: * Determine the effects of in vivo rituximab purging and maintenance on progression-free survival in patients with relapsed or resistant follicular non-Hodgkin's lymphoma undergoing high-dose chemotherapy. * Determine the effects of this regimen on response rate and overall survival in this patient population. * Determine the effects of in vivo purging with rituximab on molecular remission rates in the hematopoietic product and the patients. * Determine the safety of rituximab in the transplant setting. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to type of remission (complete vs good partial) and which remission (second vs third). Patients are randomized to one of four treatment arms. All patients receive induction chemotherapy comprising cyclophosphamide IV over 3-4 hours on day 0 or a standard induction chemotherapy regimen. Filgrastim (G-CSF) is administered subcutaneously daily beginning on day 1. Patients are then randomized to receive either in vivo rituximab purging or no purging following restaging after completion of induction. For those patients receiving purging (arms I and II), rituximab is administered IV once weekly for 4 weeks. Peripheral blood stem cells (PBSC) are collected between days 8 and 12 post induction chemotherapy. Within 4 weeks of PBSC collection, patients receive carmustine IV over 2 hours on day -6, etoposide IV over 2 hours on days -5 to -2, cytarabine IV over 5 minutes twice daily on days -5 to -2, and melphalan IV over 10-15 minutes on day -1. (Alternatively, high dose cyclophosphamide and total body irradiation beginning 2-4 weeks after cyclophosphamide or standard induction chemotherapy priming is also allowed.) PBSC are reinfused on day 0. Patients are further randomized to receive either rituximab maintenance or observation only. For those patients receiving maintenance (arms I and III), rituximab is administered IV once every 2 months for 4 doses beginning 30 days after PBSC reinfusion. Patients are followed at 30 days, 3, 6, 9, and 12 months after PBSC transplant, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 460 patients (115 per treatment arm) will be accrued for this study within 5 years.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Sydney Cancer Centre at Royal Prince Alfred Hospital, Sydney, New South Wales, Australia

Westmead Institute for Cancer Research at Westmead Hospital, Westmead, New South Wales, Australia

Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia

Royal Adelaide Hospital Cancer Centre, Adelaide, South Australia, Australia

Queen Elizabeth Hospital, Woodville, South Australia, Australia

Royal Melbourne Hospital, Parkville, Victoria, Australia

Fremantle Hospital, Fremantle, Western Australia, Australia

Royal Perth Hospital, Perth, Western Australia, Australia

Allgemeines Krankenhaus - Universitatskliniken, Vienna, , Austria

Ziekenhuis Netwerk Antwerpen Middelheim, Antwerpen, , Belgium

Institut Jules Bordet, Brussels, , Belgium

Academisch Ziekenhuis der Vrije Universiteit Brussel, Brussels, , Belgium

Universitair Ziekenhuis Gent, Ghent, , Belgium

U.Z. Gasthuisberg, Leuven, , Belgium

CHU Liege - Domaine Universitaire du Sart Tilman, Liege, , Belgium

Clinique Universitaire De Mont-Godinne, Mont-Godinne Yvoir, , Belgium

H. Hartziekenhuis - Roeselaere., Roeselaere, , Belgium

Tom Baker Cancer Centre - Calgary, Calgary, Alberta, Canada

Ottawa Hospital Regional Cancer Centre - General Campus, Ottawa, Ontario, Canada

University Hospital Kralovske Vinohr, Prague, , Czech Republic

Aalborg Hospital, Aalborg, , Denmark

Rigshospitalet - Copenhagen University Hospital, Copenhagen, , Denmark

Odense University Hospital, Odense, , Denmark

Centre Hospitalier Regional et Universitaire d'Angers, Angers, , France

Polyclinique Du Parc, Caen, , France

Centre Regional Francois Baclesse, Caen, , France

CHU de Grenoble - Hopital de la Tronche, Grenoble, , France

Centre Leon Berard, Lyon, , France

Polyclinique Saint Jean, Melun, , France

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier, , France

CHR Hotel Dieu, Nantes, , France

Hopital Saint-Louis, Paris, , France

CHU Pitie-Salpetriere, Paris, , France

Centre Hospitalier Lyon Sud, Pierre Benite, , France

Centre Hospitalier Universitaire de Rennes, Rennes, , France

Centre Henri Becquerel, Rouen, , France

Centre Hospitalier Universitaire Bretonneau de Tours, Tours, , France

Institut Gustave Roussy, Villejuif, , France

Klinikum Augsburg, Augsburg, , Germany

DIAKO Ev. Diakonie Krankenhaus gGmbH, Bremen, , Germany

Universitaetsklinikum Goettingen, Goettingen, , Germany

Asklepios Klinik St. Georg, Hamburg, , Germany

Medical University Hospital Homburg, Homburg, , Germany

Universitaetsklinikum des Saarlandes, Homburg, , Germany

Klinikum Nuernberg - Klinikum Nord, Nuernberg, , Germany

Klinikum Oldenburg, Oldenburg, , Germany

Southwest German Cancer Center at Eberhard-Karls-University, Tuebingen, , Germany

Chaim Sheba Medical Center, Tel Hashomer, , Israel

Auckland City Hospital, Auckland, , New Zealand

Canterbury Health Laboratories, Christchurch, , New Zealand

Waikato Hospital, Hamilton, , New Zealand

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, , Poland

K. Dluski Hospital-Medical Academy, Wroclaw, , Poland

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

Hospital General - Alicante, Alicante, , Spain

Hospital de Cruces, Barakaldo Bilbao, , Spain

Centro Medico Teknon, Barcelona, , Spain

Hospital de la Santa Cruz i Sant Pau, Barcelona, , Spain

Hospital Clinic de Barcelona, Barcelona, , Spain

Hospital Universitari Germans Trias i Pujol, Barcelona, , Spain

Hospital San Pedro de Alcantara, Caceres, , Spain

Hospital Universitario Puerta Del Mar, Cadiz, , Spain

Hospital General de Castellon, Castellon, , Spain

Hospital Virgen de la Arrixaca, El Palmar, , Spain

Hospital de Galdakao, Galdakao Vizcaya, , Spain

Hospital Virgen de las Nieves, Granada, , Spain

Hospital Cuidad de Jaen, Jaen, , Spain

Hospital Juan Canalejo, La Coruna, , Spain

Hospital de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria, , Spain

Hospital de la Princesa, Madrid, , Spain

Hospital General Universitario Gregorio Maranon, Madrid, , Spain

Hospital Ramon y Cajal, Madrid, , Spain

Hospital Universitario San Carlos, Madrid, , Spain

Hospital Universitario 12 de Octubre, Madrid, , Spain

Hospital Universitario de Getafe, Madrid, , Spain

Hospital General Universitario Morales Meseguer, Murcia, , Spain

Hospital Universitario Central de Asturias, Oviedo, , Spain

Hospital Son Dureta, Palma De Mallorca, , Spain

Hospital Virgen de la Vega, Salamanca, , Spain

University Hospital - Salamanca, Salamanca, , Spain

Hospital Universitario Marques de Valdecilla, Santander, , Spain

Hospital Universidad Virgen Del Rocio, Sevilla, , Spain

Hospital Mutua de Terrassa, Terrassa, , Spain

Hospital Clinico Universitario de Valencia, Valencia, , Spain

Unidad De Oncol/Hemat. Hospital, Valencia, , Spain

Complexo Hospitalario Xeral de Vigo, Vigo Pontevedra, , Spain

Hospital Clinico Universitario Lozano Blesa, Zaragoza, , Spain

Hospital Universitario Miguel Servet, Zaragoza, , Spain

Karolinska University Hospital - Huddinge, Stockholm, , Sweden

Kantonsspital Bruderholz, Bruderholz, , Switzerland

UniversitaetsSpital Zuerich, Zurich, , Switzerland

Ibn-i Sina Hospital, Ankara, , Turkey

Stoke Mandeville Hospital, Aylesbury-Buckinghamshire, England, United Kingdom

Royal United Hospital, Bath, England, United Kingdom

Birmingham Heartlands Hospital, Birmingham, England, United Kingdom

Royal Bournemouth Hospital, Bournemouth, England, United Kingdom

Bristol Haematology and Oncology Centre, Bristol, England, United Kingdom

Royal Devon and Exeter Hospital, Exeter, England, United Kingdom

Huddersfield Royal Infirmary, Huddersfield, West Yorks, England, United Kingdom

Hull Royal Infirmary, Hull, England, United Kingdom

Kettering General Hosptial, Kettering, Northants, England, United Kingdom

Clinical Trials and Research Unit of the University of Leeds, Leeds, England, United Kingdom

Leicester Royal Infirmary, Leicester, England, United Kingdom

Royal Liverpool and Broadgreen Hospitals NHS Trust, Liverpool, England, United Kingdom

Liverpool University Hospital, Liverpool, England, United Kingdom

Saint Bartholomew's Hospital, London, England, United Kingdom

St. Thomas' Hospital, London, England, United Kingdom

Clinique Sainte Elisabeth, London, England, United Kingdom

St. Georges, University of London, London, England, United Kingdom

University College Hospital - London, London, England, United Kingdom

Middlesex Hospital, London, England, United Kingdom

James Paget Hospital, Norfolk, England, United Kingdom

Nottingham City Hospital NHS Trust, Nottingham, England, United Kingdom

Oxford Radcliffe Hospital, Oxford, England, United Kingdom

Pontefract General Infirmary, Pontefract West Yorkshire, England, United Kingdom

Rotherham District General Hospital - NHS Trust, Rotherham, England, United Kingdom

Cancer Research Centre at Weston Park Hospital, Sheffield, England, United Kingdom

Southampton University Hospital NHS Trust, Southampton, England, United Kingdom

Staffordshire General Hospital, Stafford, England, United Kingdom

Royal Marsden NHS Foundation Trust - Surrey, Sutton, England, United Kingdom

Great Western Hospital, Swindon, England, United Kingdom

Princess Margaret Hospital, Swindon, England, United Kingdom

Hillingdon Hospital, Uxbridge, England, United Kingdom

Sandwell General Hospital, West Bromwich, England, United Kingdom

Centre for Cancer Research and Cell Biology at Belfast City Hospital, Belfast, Northern Ireland, United Kingdom

Aberdeen Royal Infirmary, Aberdeen, Scotland, United Kingdom

Royal Infirmary - Castle, Glasgow, Scotland, United Kingdom

Pinderfields Hospital NHS Trust, Wakefield, Scotland, United Kingdom

Ysbyty Gwynedd, Bangor, Wales, United Kingdom

Prince Philip Hospital, Dyfed, Wales, United Kingdom

Singleton Hospital of the Swansea NHS Trust, Swansea, Wales, United Kingdom

Contact Details

Name: Ruth Pettengell, MD

Affiliation: St George's, University of London

Role: STUDY_CHAIR

Name: David C. Linch

Affiliation: Middlesex Hospital

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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