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

This study is no longer recruiting patients.

Sponsored by: British National Lymphoma Investigation
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
stage III adult immunoblastic large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV grade III follicular large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma
stage III grade III follicular large cell lymphoma
 Procedure: chemotherapy
 Procedure: biological response modifier therapy
 Procedure: autologous bone marrow transplantation
 Procedure: bone marrow transplantation
 Procedure: peripheral blood stem cell transplantation
 Drug: bone marrow ablation with stem cell support
 Drug: carmustine
 Drug: cyclophosphamide
 Drug: cytarabine
 Drug: doxorubicin
 Drug: etoposide
 Drug: melphalan
 Drug: prednisone
 Drug: vincristine
Phase III

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of High Dose Chemotherapy and Autologous Bone Marrow Transplantation as Initial Therapy for Poor Risk Intermediate and High Grade Adult Non-Hodgkin's Lymphoma

Further Study Details: 

Study start: January 1993

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.

PROTOCOL 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.

Eligibility

Ages Eligible for Study:  16 Years   -   65 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

[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.]

--Prior/Concurrent Therapy--

--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

Location Information


Czech Republic
      Charles University Hospital, Prague (Praha),  128 08,  Czech Republic

Denmark
      Aarhus Amtssygehus, Aarhus,  DK 8000,  Denmark

      Rigshospitalet, Copenhagen,  2100,  Denmark

Norway
      Norwegian Radium Hospital, Oslo,  N-0310,  Norway

      Ullevall Hospital, Oslo,  N-0407 4,  Norway

      University of Tromso, Tromso,  N-9037,  Norway

United Kingdom
      Chase Farm Hospital, Enfield,  NG31 8DG,  United Kingdom

      East Surrey Hospital, Redhill,  RH1 5RH,  United Kingdom

      Epsom General Hospital, Epsom Surrey,  KT19 7EG,  United Kingdom

      Grantham and District Hospital, Grantham,  NG31 8DG,  United Kingdom

      King George Hospital, Ilford, Essex,  IG3 8YB,  United Kingdom

      Law Hospital, Carluke UK,  ML8 5ER,  United Kingdom

      Newham General Hospital, London,  E13 8RU,  United Kingdom

      Queen Elizabeth Hospital, King's Lynn,  PE30 4ET,  United Kingdom

      Rotherham District General Hospital-NHS Trust, Rotherham,  S60 2UD,  United Kingdom

      Royal Bournemouth Hospital, Bournemouth,  BH7 7DW,  United Kingdom

      Saint Richards Hospital, Chichester,  P019 4SE,  United Kingdom

      Scunthorpe General Hospital, Scunthorpe,  DN15 7BH,  United Kingdom

      St. Mary's Hospital, London,  W2 1NY,  United Kingdom

      Staffordshire General Hospital, Stafford,  ST16 3SA,  United Kingdom

      Walton General Hospital, Liverpool,  L9 1AE,  United Kingdom

      West Middlesex Hospital, Middlesex,  N18 1QZ,  United Kingdom

United Kingdom, England
      Birmingham Heartlands and Solihull NHS Trust (Teaching), Birmingham,  England,  B9 5SS,  United Kingdom

      Bristol Haematology and Oncology Centre, Bristol,  England,  BS2 8ED,  United Kingdom

      Charing Cross Hospital, London,  England,  W6 8RF,  United Kingdom

      Cheltenham General Hospital, Cheltenham,  England,  GL53 7AN,  United Kingdom

      Christie Hospital N.H.S. Trust, Manchester,  England,  M20 4BX,  United Kingdom

      City Hospital - Birmingham, Birmingham,  England,  B18 7QH,  United Kingdom

      Clatterbridge Centre for Oncology NHS Trust, MERSEYSIDE,  England,  L63 4JY,  United Kingdom

      Countess of Chester Hospital, Chester,  England,  CH2 1UL,  United Kingdom

      Derbyshire Royal Infirmary, Derby,  England,  DE1 2QY,  United Kingdom

      Derriford Hospital, Plymouth,  England,  PL6 8DH,  United Kingdom

      Good Hope Hospital Trust, West Midlands,  England,  B75 7RR,  United Kingdom

      Hillingdon Hospital, Uxbridge,  England,  UB8 3NN,  United Kingdom

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

      Ipswich Hospital NHS Trust, Ipswich,  England,  IP4 5PD,  United Kingdom

      Kent and Canterbury Hospital, Canterbury,  England,  CT2 7NR,  United Kingdom

      Leeds Teaching Hospital Trust, Leeds,  England,  LS1 3EX,  United Kingdom

      Maidstone Hospital, Maidstone,  England,  ME16 9QQ,  United Kingdom

      Middlesex Hospital- Meyerstein Institute, London,  England,  WIT 3AA,  United Kingdom

      Milton Keynes General Hospital, Milton Keynes,  England,  MK6 5LD,  United Kingdom

      Mount Vernon Hospital, Northwood,  England,  HA6 2RN,  United Kingdom

      New Cross Hospital, Wolverhampton,  England,  WV10 0QP,  United Kingdom

      Northwick Park Hospital, Harrow,  England,  HA1 3UJ,  United Kingdom

      Nottingham City Hospital NHS Trust, Nottingham,  England,  NG5 1PB,  United Kingdom

      Oldchurch Hospital, Romford,  England,  RM7 OBE,  United Kingdom

      Oxford Radcliffe Hospital, Oxford,  England,  0X3 9DU,  United Kingdom

      Pembury Hospital, Royal Tunbridge Wells, Kent,  England,  TN2 4QJ,  United Kingdom

      Pontefract General Infirmary, West Yorks,  England,  WF8 1PL,  United Kingdom

      Queen's Hospital, Burton, Burton upon Trent,  England,  DE14 3QH,  United Kingdom

      Royal Free Hospital, Hampstead, London,  England,  NW3 2QG,  United Kingdom

      Royal Liverpool and Broadgreen Hospitals, Liverpool,  England,  L7 8XP,  United Kingdom

      Royal Marsden Hospital, Sutton,  England,  SM2 5PT,  United Kingdom

      Royal South Hants Hospital, Southampton,  England,  SO14 0YG,  United Kingdom

      Royal United Hospital, Bath,  England,  BA1 3NG,  United Kingdom

      Saint Bartholomew's Hospital, London,  England,  EC1A 7BE,  United Kingdom

      Sandwell District General Hospital, West Bromwich,  England,  United Kingdom

      Sheffield Teaching Hospitals, Sheffield,  England,  S1O 2JF,  United Kingdom

      Southmead Hospital, Bristol,  England,  BS10 5NB,  United Kingdom

      Southport and Formby District General Hospital, MERSEYSIDE,  England,  PR8 6NJ,  United Kingdom

      St. Bartholomew's Hospital, London,  England,  EC1A 7BE,  United Kingdom

      St. Georges Hospital Medical School, London,  England,  SW17 ORE,  United Kingdom

      Stoke Mandeville Hospital, Aylesbury-Buckinghamshire,  England,  HP21 8AL,  United Kingdom

      Torbay Hospital, Torquay Devon,  England,  TQ2 7AA,  United Kingdom

      University College London, London,  England,  W1W 7EJ,  United Kingdom

      University College London Medical School, London,  England,  W1N 8AA,  United Kingdom

      University Hospitals of Leicester, Leicester,  England,  LE1 5WW,  United Kingdom

      Weston Park Hospital, Sheffield,  England,  S1O 2SJ,  United Kingdom

      Whipps Cross Hospital, London,  England,  E11 1NR,  United Kingdom

United Kingdom, Northern Ireland
      Altnagelvin Area Hospital, Londonderry,  Northern Ireland,  BT47 1SB,  United Kingdom

      Belfast City Hospital Trust, Belfast,  Northern Ireland,  BT9 7AB,  United Kingdom

United Kingdom, Wales
      Ysbyty Gwynedd, Bangor,  Wales,  LL57 2PW,  United Kingdom

Study chairs or principal investigators

David C. Linch,  Study Chair,  British National Lymphoma Investigation   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066645; BNLI-LY02; EU-98039
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003578
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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