High Dose Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma
A Randomized Trial to Evaluate Early High Dose Therapy and Autologous Bone Marrow Transplantation as Part of Planned Initial Therapy for Poor Risk Intermediate/High Grade NHL
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether high dose chemotherapy plus bone marrow transplantation is more effective than high dose chemotherapy alone for intermediate- or high-grade non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy with or without bone marrow transplantation in treating patients who have intermediate- or high-grade non-Hodgkin's lymphoma.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES: I. Assess the value of early intensification with autologous bone marrow transplantation or stem cell support in patients with poor prognosis intermediate or high grade non-Hodgkin's lymphoma.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by age (under 50 vs 50 and over), bone marrow involvement (yes vs no), and country. All patients receive cyclophosphamide, doxorubicin, and vincristine on day 1 and prednisone on days 1-5. Courses repeat every 21 days. Patients receive a minimum of 6 courses of treatment in the absence of disease progression and unacceptable toxicity. Arm I: Patients receive carmustine IV over 2 hours on day 1 in week 9 or 10. Etoposide and cytarabine IV are administered over 30 minutes on days 2-5. Melphalan IV is administered over 5 minutes on day 6. Patients receive cryopreserved bone marrow or peripheral blood stem cells on day 7. Arm II: Patients continue conventional therapy. Patients are followed at 8-9 weeks and 6 months.
PROJECTED ACCRUAL: This study will accrue 500 patients.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
-
-
-
Aarhus, Danimarca, DK 8000
- Aarhus Amtssygehus
-
Copenhagen, Danimarca, 2100
- Rigshospitalet
-
-
-
-
-
Oslo, Norvegia, N-0310
- Norwegian Radium Hospital
-
Oslo, Norvegia, N-0407 4
- Ullevall Hospital
-
Tromso, Norvegia, N-9037
- University of Tromso
-
-
-
-
-
Bournemouth, Regno Unito, BH7 7DW
- Royal Bournemouth Hospital
-
Carluke UK, Regno Unito, ML8 5ER
- Law Hospital
-
Chichester, Regno Unito, P019 4SE
- Saint Richards Hospital
-
Enfield, Regno Unito, NG31 8DG
- Chase Farm Hospital
-
Epsom Surrey, Regno Unito, KT19 7EG
- Epsom General Hospital
-
Grantham, Regno Unito, NG31 8DG
- Grantham and District Hospital
-
Ilford, Essex, Regno Unito, IG3 8YB
- King George Hospital
-
King's Lynn, Regno Unito, PE30 4ET
- Queen Elizabeth Hospital
-
Liverpool, Regno Unito, L9 1AE
- Walton General Hospital
-
London, Regno Unito, W2 1NY
- St. Mary's Hospital
-
London, Regno Unito, E13 8RU
- Newham General Hospital
-
Middlesex, Regno Unito, N18 1QZ
- West Middlesex Hospital
-
Redhill, Regno Unito, RH1 5RH
- East Surrey Hospital
-
Rotherham, Regno Unito, S60 2UD
- Rotherham District General Hospital-NHS Trust
-
Scunthorpe, Regno Unito, DN15 7BH
- Scunthorpe General Hospital
-
Stafford, Regno Unito, ST16 3SA
- Staffordshire General Hospital
-
-
England
-
Aylesbury-Buckinghamshire, England, Regno Unito, HP21 8AL
- Stoke Mandeville Hospital
-
Bath, England, Regno Unito, BA1 3NG
- Royal United Hospital
-
Birmingham, England, Regno Unito, B18 7QH
- City Hospital - Birmingham
-
Birmingham, England, Regno Unito, B9 5SS
- Birmingham Heartlands and Solihull NHS Trust (Teaching)
-
Bristol, England, Regno Unito, BS2 8ED
- Bristol Haematology and Oncology Centre
-
Bristol, England, Regno Unito, BS10 5NB
- Southmead Hospital
-
Burton-upon-Trent, England, Regno Unito, DE14 3QH
- Queen's Hospital, Burton
-
Canterbury, England, Regno Unito, CT2 7NR
- Kent and Canterbury Hospital
-
Cheltenham, England, Regno Unito, GL53 7AN
- Cheltenham General Hospital
-
Chester, England, Regno Unito, CH2 1UL
- Countess of Chester Hospital
-
Derby, England, Regno Unito, DE1 2QY
- Derbyshire Royal Infirmary
-
Hampstead, London, England, Regno Unito, NW3 2QG
- Royal Free Hospital
-
Harrow, England, Regno Unito, HA1 3UJ
- Northwick Park Hospital
-
Huddersfield, West Yorks, England, Regno Unito, HD3 3EA
- Huddersfield Royal Infirmary
-
Ipswich, England, Regno Unito, IP4 5PD
- Ipswich Hospital NHS Trust
-
Leeds, England, Regno Unito, LS1 3EX
- Leeds Teaching Hospital Trust
-
Leicester, England, Regno Unito, LE1 5WW
- University Hospitals of Leicester
-
Liverpool, England, Regno Unito, L7 8XP
- Royal Liverpool and Broadgreen Hospitals
-
London, England, Regno Unito, EC1A 7BE
- Saint Bartholomew's Hospital
-
London, England, Regno Unito, SW17 ORE
- St. Georges Hospital Medical School
-
London, England, Regno Unito, W6 8RF
- Charing Cross Hospital
-
London, England, Regno Unito, E11 1NR
- Whipps Cross Hospital
-
London, England, Regno Unito, WIT 3AA
- Middlesex Hospital- Meyerstein Institute
-
London, England, Regno Unito, W1W 7EJ
- University College London
-
London, England, Regno Unito, EC1A 7BE
- St. Bartholomew's Hospital
-
London, England, Regno Unito, W1N 8AA
- University College London Medical School
-
Maidstone, England, Regno Unito, ME16 9QQ
- Maidstone Hospital
-
Manchester, England, Regno Unito, M20 4BX
- Christie Hospital N.H.S. Trust
-
Merseyside, England, Regno Unito, L63 4JY
- Clatterbridge Centre for Oncology NHS Trust
-
Merseyside, England, Regno Unito, PR8 6NJ
- Southport and Formby District General Hospital
-
Milton Keynes, England, Regno Unito, MK6 5LD
- Milton Keynes General Hospital
-
Northwood, England, Regno Unito, HA6 2RN
- Mount Vernon Hospital
-
Nottingham, England, Regno Unito, NG5 1PB
- Nottingham City Hospital NHS Trust
-
Oxford, England, Regno Unito, 0X3 9DU
- Oxford Radcliffe Hospital
-
Plymouth, England, Regno Unito, PL6 8DH
- Derriford Hospital
-
Romford, England, Regno Unito, RM7 OBE
- Oldchurch Hospital
-
Royal Tunbridge Wells, Kent, England, Regno Unito, TN2 4QJ
- Pembury Hospital
-
Sheffield, England, Regno Unito, S1O 2SJ
- Weston Park Hospital
-
Sheffield, England, Regno Unito, S1O 2JF
- Sheffield Teaching Hospitals
-
Southampton, England, Regno Unito, SO14 0YG
- Royal South Hants Hospital
-
Sutton, England, Regno Unito, SM2 5PT
- Royal Marsden Hospital
-
Torquay Devon, England, Regno Unito, TQ2 7AA
- Torbay Hospital
-
Uxbridge, England, Regno Unito, UB8 3NN
- Hillingdon Hospital
-
West Bromwich, England, Regno Unito
- Sandwell District General Hospital
-
West Midlands, England, Regno Unito, B75 7RR
- Good Hope Hospital Trust
-
West Yorks, England, Regno Unito, WF8 1PL
- Pontefract General Infirmary
-
Wolverhampton, England, Regno Unito, WV10 0QP
- New Cross Hospital
-
-
Northern Ireland
-
Belfast, Northern Ireland, Regno Unito, BT9 7AB
- Belfast City Hospital Trust
-
Londonderry, Northern Ireland, Regno Unito, BT47 1SB
- Altnagelvin Area Hospital
-
-
Wales
-
Bangor, Wales, Regno Unito, LL57 2PW
- Ysbyty Gwynedd
-
-
-
-
-
Prague (Praha), Repubblica Ceca, 128 08
- Charles University Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS: Histologically confirmed intermediate or high grade adult non-Hodgkin's lymphoma: Follicular large cell lymphoma Diffuse mixed cell lymphoma Diffuse large cell lymphoma Diffuse immunoblastic lymphoma Poor prognostic features defined as the presence of 2 or 3 of the following: Stage III/IV Lactase dehydrogenase greater than normal ECOG performance status 2-4 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: 16 to 65 Performance status: See Disease Characteristics Life expectancy: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics Renal: Not specified Other: No other medical condition prohibiting intensive therapy
PRIOR CONCURRENT THERAPY: At least 5 years since prior systemic therapy for cancer
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: David C. Linch, University College London Hospitals
Studiare le date dei record
Studia le date principali
Inizio studio
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- linfoma diffuso a grandi cellule dell'adulto in stadio III
- Linfoma immunoblastico a grandi cellule dell'adulto in stadio III
- linfoma follicolare di grado 3 stadio IV
- linfoma diffuso a grandi cellule dell'adulto in stadio IV
- Linfoma immunoblastico a grandi cellule dell'adulto in stadio IV
- linfoma follicolare stadio III grado 3
- linfoma diffuso a cellule miste in stadio III dell'adulto
- linfoma diffuso a cellule miste adulto stadio IV
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Linfoma
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfettivi
- Agenti antivirali
- Inibitori enzimatici
- Agenti antinfiammatori
- Agenti antireumatici
- Antimetaboliti, Antineoplastici
- Antimetaboliti
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Glucocorticoidi
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Agenti antineoplastici, ormonali
- Agenti Antineoplastici, Alchilanti
- Agenti Alchilanti
- Agonisti mieloablativi
- Agenti antineoplastici, fitogenici
- Inibitori della topoisomerasi II
- Inibitori della topoisomerasi
- Antibiotici, Antineoplastici
- Ciclofosfamide
- Etoposide
- Prednisone
- Melfalan
- Doxorubicina
- Doxorubicina liposomiale
- Citarabina
- Vincristina
- Carmustina
Altri numeri di identificazione dello studio
- CDR0000066645
- BNLI-LY02
- EU-98039
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .