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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Ruth Pettengell, MD
Affiliation: St George's, University of London
Role: STUDY_CHAIR
Name: David C. Linch
Affiliation: Middlesex Hospital
Role: STUDY_CHAIR