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

NCT00005589 | Completed Phase 3

• 4 other identifiers: CDR0000067665EBMT-EBMTLYM1BNLI-EBMT-EBMTLYM1EU-99050
• Study Type: interventional
• Target: 460
• Locations: 16 countries
• Sites: 130

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.

Conditions

Lymphoma

Keywords

recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma

Outcome Measures

Primary Outcomes (1)

• Time to disease progression

Secondary Outcomes (3)

• Response rate and survival

• Molecular remission rates

• Safety

Interventions

filgrastim BIOLOGICAL

rituximab BIOLOGICAL

carmustine DRUG

cyclophosphamide DRUG

cytarabine DRUG

etoposide DRUG

melphalan DRUG

bone marrow ablation with stem cell support PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Relapsed or resistant follicular non-Hodgkin's lymphoma (NHL) * No evidence of transformation to high grade or diffuse large B-cell NHL * CD20 positive with no evidence of transformation * Achievement of complete remission (CR) or very good partial remission (VGPR) following reinduction chemotherapy with any standard regimen * Includes patients who fail to respond to first-line chemotherapy but who achieve CR or VGPR after proceeding directly to second-line chemotherapy * Platelet count greater than 100,000/mm\^3 after induction chemotherapy and before randomization * No CNS involvement PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Bilirubin normal * ALT no greater than 2 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2 times ULN * Hepatitis B negative * Hepatitis C negative Renal: * Creatinine no greater than 2 times ULN * BUN no greater than 2 times ULN Cardiovascular: * No inadequate cardiac function Pulmonary: * No inadequate pulmonary function Other: * Not pregnant or nursing * HIV negative * No other uncontrolled serious medical conditions * No other malignancy within the past 5 years except nonmelanoma skin tumors or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * More than 12 months since prior CD20 therapy, including rituximab * No prior peripheral blood stem cell transplantation Chemotherapy: * See Disease Characteristics * No more than 3 prior chemotherapy regimens for NHL Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to greater than 30% of bone marrow Surgery: * Not specified

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

Sponsors & Collaborators

• EBMT Solid Tumors Working Party: lead
• Lymphoma Trials Office: collaborator

Study Sites (131)

Sydney Cancer Centre at Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

Westmead Institute for Cancer Research at Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

Location

Royal Adelaide Hospital Cancer Centre

Adelaide, South Australia, 5000, Australia

Location

Queen Elizabeth Hospital

Woodville, South Australia, 5011, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Fremantle Hospital

Fremantle, Western Australia, 6160, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Allgemeines Krankenhaus - Universitatskliniken

Vienna, A-1090, Austria

Location

Ziekenhuis Netwerk Antwerpen Middelheim

Antwerp, B-2020, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels, 1090, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

CHU Liege - Domaine Universitaire du Sart Tilman

Liège, B-4000, Belgium

Location

Clinique Universitaire De Mont-Godinne

Mont-Godinne Yvoir, 5530, Belgium

Location

H. Hartziekenhuis - Roeselaere.

Roeselaere, 8800, Belgium

Location

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

University Hospital Kralovske Vinohr

Prague, 10034, Czechia

Location

Aalborg Hospital

Aalborg, DK-9000, Denmark

Location

Rigshospitalet - Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Odense University Hospital

Odense, DK-5000, Denmark

Location

Centre Hospitalier Regional et Universitaire d'Angers

Angers, 49033, France

Location

Polyclinique Du Parc

Caen, 14052, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

CHU de Grenoble - Hopital de la Tronche

Grenoble, 38043, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Polyclinique Saint Jean

Melun, 77000, France

Location

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

Montpellier, 34298, France

Location

CHR Hotel Dieu

Nantes, 44093, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre Hospitalier Universitaire de Rennes

Rennes, 35033, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre Hospitalier Universitaire Bretonneau de Tours

Tours, 37044, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Klinikum Augsburg

Augsburg, DOH-86156, Germany

Location

DIAKO Ev. Diakonie Krankenhaus gGmbH

Bremen, D-28239, Germany

Location

Universitaetsklinikum Goettingen

Göttingen, D-37075, Germany

Location

Asklepios Klinik St. Georg

Hamburg, D-20099, Germany

Location

Medical University Hospital Homburg

Homburg, 66421, Germany

Location

Universitaetsklinikum des Saarlandes

Homburg, D-66424, Germany

Location

Klinikum Nuernberg - Klinikum Nord

Nuremberg, D-90419, Germany

Location

Klinikum Oldenburg

Oldenburg, D-26133, Germany

Location

Southwest German Cancer Center at Eberhard-Karls-University

Tübingen, D-72076, Germany

Location

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Auckland City Hospital

Auckland, 1, New Zealand

Location

Canterbury Health Laboratories

Christchurch, New Zealand

Location

Waikato Hospital

Hamilton, 2020, New Zealand

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, 02-781, Poland

Location

K. Dluski Hospital-Medical Academy

Wroclaw, 53 439, Poland

Location

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

Lisbon, 1099-023 Codex, Portugal

Location

Hospital Juan Canalejo

A Coruña, 15000, Spain

Location

Hospital General - Alicante

Alicante, 3010, Spain

Location

Hospital de Cruces

Barakaldo Bilbao, E-48903, Spain

Location

Centro Medico Teknon

Barcelona, 08022, Spain

Location

Hospital de la Santa Cruz i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitari Germans Trias i Pujol

Barcelona, 08916, Spain

Location

Hospital Universitario Puerta Del Mar

Cadiz, 11000, Spain

Location

Hospital General de Castellon

Castellon, 12004, Spain

Location

Hospital San Pedro de Alcantara

Cáceres, 10000, Spain

Location

Hospital Virgen de la Arrixaca

El Palmar, 30120, Spain

Location

Hospital de Galdakao

Galdakao Vizcaya, 48000, Spain

Location

Hospital Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Cuidad de Jaen

Jaén, E-23006, Spain

Location

Hospital de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, 350311, Spain

Location

Hospital de la Princesa

Madrid, 28006, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario de Getafe

Madrid, 28905, Spain

Location

Hospital General Universitario Morales Meseguer

Murcia, 30008, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33006, Spain

Location

Hospital Son Dureta

Palma de Mallorca, 07014, Spain

Location

Hospital Virgen de la Vega

Salamanca, 37007, Spain

Location

University Hospital - Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Hospital Universidad Virgen Del Rocio

Seville, E- 41013, Spain

Location

Hospital Mutua de Terrassa

Terrassa, 08221, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Unidad De Oncol/Hemat. Hospital

Valencia, 46017, Spain

Location

Complexo Hospitalario Xeral de Vigo

Vigo Pontevedra, 36204, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50006, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Karolinska University Hospital - Huddinge

Stockholm, SE-141 86, Sweden

Location

Kantonsspital Bruderholz

Bruderholz, CH-4101, Switzerland

Location

UniversitaetsSpital Zuerich

Zurich, CH-8091, Switzerland

Location

Ibn-i Sina Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Stoke Mandeville Hospital

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

Location

Royal United Hospital

Bath, England, BA1 3NG, United Kingdom

Location

Birmingham Heartlands Hospital

Birmingham, England, B9 5SS, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, England, BH7 7DW, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, HD3 3EA, United Kingdom

Location

Hull Royal Infirmary

Hull, England, HU3 2KZ, United Kingdom

Location

Kettering General Hosptial

Kettering, Northants, England, NNI6 8UZ, United Kingdom

Location

Clinical Trials and Research Unit of the University of Leeds

Leeds, England, LS2 9N9, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Royal Liverpool and Broadgreen Hospitals NHS Trust

Liverpool, England, L7 8XP, United Kingdom

Location

Liverpool University Hospital

Liverpool, England, L9 7AL, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

St. Thomas' Hospital

London, England, SE1 7EH, United Kingdom

Location

Clinique Sainte Elisabeth

London, England, SW17 ORE, United Kingdom

Location

St. Georges, University of London

London, England, SW17 ORE, United Kingdom

Location

University College Hospital - London

London, England, WC1E 6AU, United Kingdom

Location

Middlesex Hospital

London, England, WC1E 6HX, United Kingdom

Location

James Paget Hospital

Norfolk, England, NR31 6LA, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Pontefract General Infirmary

Pontefract West Yorkshire, England, WF8 1PL, United Kingdom

Location

Rotherham District General Hospital - NHS Trust

Rotherham, England, S60 2UD, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Southampton University Hospital NHS Trust

Southampton, England, SO16 6YD, United Kingdom

Location

Staffordshire General Hospital

Stafford, England, ST16 3SA, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Great Western Hospital

Swindon, England, SN3 6BB, United Kingdom

Location

Princess Margaret Hospital

Swindon, England, SN3 6BB, United Kingdom

Location

Hillingdon Hospital

Uxbridge, England, UB8 3NN, United Kingdom

Location

Sandwell General Hospital

West Bromwich, England, B71 4HJ, United Kingdom

Location

Centre for Cancer Research and Cell Biology at Belfast City Hospital

Belfast, Northern Ireland, BT9 7AB, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Royal Infirmary - Castle

Glasgow, Scotland, G4 0SF, United Kingdom

Location

Pinderfields Hospital NHS Trust

Wakefield, Scotland, WF1 4DG, United Kingdom

Location

Ysbyty Gwynedd

Bangor, Wales, LL57 2PW, United Kingdom

Location

Prince Philip Hospital

Dyfed, Wales, SA14 8QF, United Kingdom

Location

Singleton Hospital of the Swansea NHS Trust

Swansea, Wales, SA2 8QA, United Kingdom

Location

Related Publications (1)

• Pettengell R, Schmitz N, Gisselbrecht C, Smith G, Patton WN, Metzner B, Caballero D, Tilly H, Walewski JA, Bence-Bruckler I, To B, Geisler CH, Schots R, Kimby E, Taverna CJ, Kozak T, Dreger P, Uddin R, Ruiz de Elvira C, Goldstone AH. Rituximab purging and/or maintenance in patients undergoing autologous transplantation for relapsed follicular lymphoma: a prospective randomized trial from the lymphoma working party of the European group for blood and marrow transplantation. J Clin Oncol. 2013 May 1;31(13):1624-30. doi: 10.1200/JCO.2012.47.1862. Epub 2013 Apr 1.

  PMID: 23547078 DERIVED

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular

Interventions

Filgrastim; Rituximab; Carmustine; Cyclophosphamide; Cytarabine; Etoposide; Melphalan; Peripheral Blood Stem Cell Transplantation

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)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Ruth Pettengell, MD

  St George's, University of London

  STUDY CHAIR

• David C. Linch

  Middlesex Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2000
• First Posted: January 27, 2003
• Study Start: October 1, 1999
• Study Completion: April 1, 2013
• Last Updated: September 17, 2013

Record last verified: 2007-03

Locations

TU (1); GB (39); CA (2); AU (8); CZ (1); BE (8); DE (9); IL (1); NZ (3); FR (15); PL (2); ES (34); PT (1); CH (2); DK (3); SE (1)