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High Dose Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma

19. september 2013 opdateret af: Lymphoma Trials Office

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

500

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
      • Aarhus, Danmark, DK 8000
        • Aarhus Amtssygehus
      • Copenhagen, Danmark, 2100
        • Rigshospitalet
  • Det Forenede Kongerige
      • Bournemouth, Det Forenede Kongerige, BH7 7DW
        • Royal Bournemouth Hospital
      • Carluke UK, Det Forenede Kongerige, ML8 5ER
        • Law Hospital
      • Chichester, Det Forenede Kongerige, P019 4SE
        • Saint Richards Hospital
      • Enfield, Det Forenede Kongerige, NG31 8DG
        • Chase Farm Hospital
      • Epsom Surrey, Det Forenede Kongerige, KT19 7EG
        • Epsom General Hospital
      • Grantham, Det Forenede Kongerige, NG31 8DG
        • Grantham and District Hospital
      • Ilford, Essex, Det Forenede Kongerige, IG3 8YB
        • King George Hospital
      • King's Lynn, Det Forenede Kongerige, PE30 4ET
        • Queen Elizabeth Hospital
      • Liverpool, Det Forenede Kongerige, L9 1AE
        • Walton General Hospital
      • London, Det Forenede Kongerige, W2 1NY
        • St. Mary's Hospital
      • London, Det Forenede Kongerige, E13 8RU
        • Newham General Hospital
      • Middlesex, Det Forenede Kongerige, N18 1QZ
        • West Middlesex Hospital
      • Redhill, Det Forenede Kongerige, RH1 5RH
        • East Surrey Hospital
      • Rotherham, Det Forenede Kongerige, S60 2UD
        • Rotherham District General Hospital-NHS Trust
      • Scunthorpe, Det Forenede Kongerige, DN15 7BH
        • Scunthorpe General Hospital
      • Stafford, Det Forenede Kongerige, ST16 3SA
        • Staffordshire General Hospital
    • England
      • Aylesbury-Buckinghamshire, England, Det Forenede Kongerige, HP21 8AL
        • Stoke Mandeville Hospital
      • Bath, England, Det Forenede Kongerige, BA1 3NG
        • Royal United Hospital
      • Birmingham, England, Det Forenede Kongerige, B18 7QH
        • City Hospital - Birmingham
      • Birmingham, England, Det Forenede Kongerige, B9 5SS
        • Birmingham Heartlands and Solihull NHS Trust (Teaching)
      • Bristol, England, Det Forenede Kongerige, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Bristol, England, Det Forenede Kongerige, BS10 5NB
        • Southmead Hospital
      • Burton-upon-Trent, England, Det Forenede Kongerige, DE14 3QH
        • Queen's Hospital, Burton
      • Canterbury, England, Det Forenede Kongerige, CT2 7NR
        • Kent and Canterbury Hospital
      • Cheltenham, England, Det Forenede Kongerige, GL53 7AN
        • Cheltenham General Hospital
      • Chester, England, Det Forenede Kongerige, CH2 1UL
        • Countess of Chester Hospital
      • Derby, England, Det Forenede Kongerige, DE1 2QY
        • Derbyshire Royal Infirmary
      • Hampstead, London, England, Det Forenede Kongerige, NW3 2QG
        • Royal Free Hospital
      • Harrow, England, Det Forenede Kongerige, HA1 3UJ
        • Northwick Park Hospital
      • Huddersfield, West Yorks, England, Det Forenede Kongerige, HD3 3EA
        • Huddersfield Royal Infirmary
      • Ipswich, England, Det Forenede Kongerige, IP4 5PD
        • Ipswich Hospital NHS Trust
      • Leeds, England, Det Forenede Kongerige, LS1 3EX
        • Leeds Teaching Hospital Trust
      • Leicester, England, Det Forenede Kongerige, LE1 5WW
        • University Hospitals of Leicester
      • Liverpool, England, Det Forenede Kongerige, L7 8XP
        • Royal Liverpool and Broadgreen Hospitals
      • London, England, Det Forenede Kongerige, EC1A 7BE
        • Saint Bartholomew's Hospital
      • London, England, Det Forenede Kongerige, SW17 ORE
        • St. Georges Hospital Medical School
      • London, England, Det Forenede Kongerige, W6 8RF
        • Charing Cross Hospital
      • London, England, Det Forenede Kongerige, E11 1NR
        • Whipps Cross Hospital
      • London, England, Det Forenede Kongerige, WIT 3AA
        • Middlesex Hospital- Meyerstein Institute
      • London, England, Det Forenede Kongerige, W1W 7EJ
        • University College London
      • London, England, Det Forenede Kongerige, EC1A 7BE
        • St. Bartholomew's Hospital
      • London, England, Det Forenede Kongerige, W1N 8AA
        • University College London Medical School
      • Maidstone, England, Det Forenede Kongerige, ME16 9QQ
        • Maidstone Hospital
      • Manchester, England, Det Forenede Kongerige, M20 4BX
        • Christie Hospital N.H.S. Trust
      • Merseyside, England, Det Forenede Kongerige, L63 4JY
        • Clatterbridge Centre for Oncology NHS Trust
      • Merseyside, England, Det Forenede Kongerige, PR8 6NJ
        • Southport and Formby District General Hospital
      • Milton Keynes, England, Det Forenede Kongerige, MK6 5LD
        • Milton Keynes General Hospital
      • Northwood, England, Det Forenede Kongerige, HA6 2RN
        • Mount Vernon Hospital
      • Nottingham, England, Det Forenede Kongerige, NG5 1PB
        • Nottingham City Hospital NHS Trust
      • Oxford, England, Det Forenede Kongerige, 0X3 9DU
        • Oxford Radcliffe Hospital
      • Plymouth, England, Det Forenede Kongerige, PL6 8DH
        • Derriford Hospital
      • Romford, England, Det Forenede Kongerige, RM7 OBE
        • Oldchurch Hospital
      • Royal Tunbridge Wells, Kent, England, Det Forenede Kongerige, TN2 4QJ
        • Pembury Hospital
      • Sheffield, England, Det Forenede Kongerige, S1O 2SJ
        • Weston Park Hospital
      • Sheffield, England, Det Forenede Kongerige, S1O 2JF
        • Sheffield Teaching Hospitals
      • Southampton, England, Det Forenede Kongerige, SO14 0YG
        • Royal South Hants Hospital
      • Sutton, England, Det Forenede Kongerige, SM2 5PT
        • Royal Marsden Hospital
      • Torquay Devon, England, Det Forenede Kongerige, TQ2 7AA
        • Torbay Hospital
      • Uxbridge, England, Det Forenede Kongerige, UB8 3NN
        • Hillingdon Hospital
      • West Bromwich, England, Det Forenede Kongerige
        • Sandwell District General Hospital
      • West Midlands, England, Det Forenede Kongerige, B75 7RR
        • Good Hope Hospital Trust
      • West Yorks, England, Det Forenede Kongerige, WF8 1PL
        • Pontefract General Infirmary
      • Wolverhampton, England, Det Forenede Kongerige, WV10 0QP
        • New Cross Hospital
    • Northern Ireland
      • Belfast, Northern Ireland, Det Forenede Kongerige, BT9 7AB
        • Belfast City Hospital Trust
      • Londonderry, Northern Ireland, Det Forenede Kongerige, BT47 1SB
        • Altnagelvin Area Hospital
    • Wales
      • Bangor, Wales, Det Forenede Kongerige, LL57 2PW
        • Ysbyty Gwynedd
  • Norge
      • Oslo, Norge, N-0310
        • Norwegian Radium Hospital
      • Oslo, Norge, N-0407 4
        • Ullevall Hospital
      • Tromso, Norge, N-9037
        • University of Tromso
  • Tjekkiet
      • Prague (Praha), Tjekkiet, 128 08
        • Charles University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

16 år til 65 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Lymphoma Trials Office

Efterforskere

  • Studiestol: David C. Linch, University College London Hospitals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 1993

Datoer for studieregistrering

Først indsendt

1. november 1999

Først indsendt, der opfyldte QC-kriterier

26. januar 2004

Først opslået (Skøn)

27. januar 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. september 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. september 2013

Sidst verificeret

1. maj 2007

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000066645
  • BNLI-LY02
  • EU-98039

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Placeringer

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