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

NCT00003578 | Unknown Phase 3

• 3 other identifiers: CDR0000066645BNLI-LY02EU-98039
• Study Type: interventional
• Target: 500
• Locations: 4 countries
• Sites: 72

Brief Summary

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.

Conditions

Lymphoma

Keywords

stage III grade 3 follicular lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse large cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage IV grade 3 follicular lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult immunoblastic large cell lymphoma

Interventions

CHOP regimen DRUG

carmustine DRUG

cyclophosphamide DRUG

cytarabine DRUG

doxorubicin hydrochloride DRUG

etoposide DRUG

melphalan DRUG

prednisone DRUG

vincristine sulfate DRUG

autologous bone marrow transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Lymphoma Trials Office: lead

Study Sites (72)

Charles University Hospital

Prague (Praha), 128 08, Czechia

Location

Aarhus Amtssygehus

Aarhus, DK 8000, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Ullevall Hospital

Oslo, N-0407 4, Norway

Location

University of Tromso

Tromsø, N-9037, Norway

Location

Stoke Mandeville Hospital

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

Location

Royal United Hospital

Bath, England, BA1 3NG, United Kingdom

Location

City Hospital - Birmingham

Birmingham, England, B18 7QH, United Kingdom

Location

Birmingham Heartlands and Solihull NHS Trust (Teaching)

Birmingham, England, B9 5SS, United Kingdom

Location

Southmead Hospital

Bristol, England, BS10 5NB, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Queen's Hospital, Burton

Burton-on-Trent, England, DE14 3QH, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, England, CT2 7NR, United Kingdom

Location

Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

Location

Countess of Chester Hospital

Chester, England, CH2 1UL, United Kingdom

Location

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

Location

Royal Free Hospital

Hampstead, London, England, NW3 2QG, United Kingdom

Location

Northwick Park Hospital

Harrow, England, HA1 3UJ, United Kingdom

Location

Huddersfield Royal Infirmary

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

Location

Ipswich Hospital NHS Trust

Ipswich, England, IP4 5PD, United Kingdom

Location

Leeds Teaching Hospital Trust

Leeds, England, LS1 3EX, United Kingdom

Location

University Hospitals of Leicester

Leicester, England, LE1 5WW, United Kingdom

Location

Royal Liverpool and Broadgreen Hospitals

Liverpool, England, L7 8XP, United Kingdom

Location

Whipps Cross Hospital

London, England, E11 1NR, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

St. Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

St. Georges Hospital Medical School

London, England, SW17 ORE, United Kingdom

Location

University College London Medical School

London, England, W1N 8AA, United Kingdom

Location

University College London

London, England, W1W 7EJ, United Kingdom

Location

Charing Cross Hospital

London, England, W6 8RF, United Kingdom

Location

Middlesex Hospital- Meyerstein Institute

London, England, WIT 3AA, United Kingdom

Location

Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Christie Hospital N.H.S. Trust

Manchester, England, M20 4BX, United Kingdom

Location

Clatterbridge Centre for Oncology NHS Trust

Merseyside, England, L63 4JY, United Kingdom

Location

Southport and Formby District General Hospital

Merseyside, England, PR8 6NJ, United Kingdom

Location

Milton Keynes General Hospital

Milton Keynes, England, MK6 5LD, United Kingdom

Location

Mount Vernon Hospital

Northwood, England, HA6 2RN, 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

Derriford Hospital

Plymouth, England, PL6 8DH, United Kingdom

Location

Oldchurch Hospital

Romford, England, RM7 OBE, United Kingdom

Location

Pembury Hospital

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

Location

Sheffield Teaching Hospitals

Sheffield, England, S1O 2JF, United Kingdom

Location

Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Royal South Hants Hospital

Southampton, England, SO14 0YG, United Kingdom

Location

Royal Marsden Hospital

Sutton, England, SM2 5PT, United Kingdom

Location

Torbay Hospital

Torquay Devon, England, TQ2 7AA, United Kingdom

Location

Hillingdon Hospital

Uxbridge, England, UB8 3NN, United Kingdom

Location

Sandwell District General Hospital

West Bromwich, England, United Kingdom

Location

Good Hope Hospital Trust

West Midlands, England, B75 7RR, United Kingdom

Location

Pontefract General Infirmary

West Yorks, England, WF8 1PL, United Kingdom

Location

New Cross Hospital

Wolverhampton, England, WV10 0QP, United Kingdom

Location

Belfast City Hospital Trust

Belfast, Northern Ireland, BT9 7AB, United Kingdom

Location

Altnagelvin Area Hospital

Londonderry, Northern Ireland, BT47 1SB, United Kingdom

Location

Ysbyty Gwynedd

Bangor, Wales, LL57 2PW, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

Law Hospital

Carluke UK, ML8 5ER, United Kingdom

Location

Saint Richards Hospital

Chichester, P019 4SE, United Kingdom

Location

Chase Farm Hospital

Enfield, NG31 8DG, United Kingdom

Location

Epsom General Hospital

Epsom Surrey, KT19 7EG, United Kingdom

Location

Grantham and District Hospital

Grantham, NG31 8DG, United Kingdom

Location

King George Hospital

Ilford, Essex, IG3 8YB, United Kingdom

Location

Queen Elizabeth Hospital

Kings Lynn, PE30 4ET, United Kingdom

Location

Walton General Hospital

Liverpool, L9 1AE, United Kingdom

Location

Newham General Hospital

London, E13 8RU, United Kingdom

Location

St. Mary's Hospital

London, W2 1NY, United Kingdom

Location

West Middlesex Hospital

Middlesex, N18 1QZ, United Kingdom

Location

East Surrey Hospital

Redhill, RH1 5RH, United Kingdom

Location

Rotherham District General Hospital-NHS Trust

Rotherham, S60 2UD, United Kingdom

Location

Scunthorpe General Hospital

Scunthorpe, DN15 7BH, United Kingdom

Location

Staffordshire General Hospital

Stafford, ST16 3SA, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic

Interventions

VAP-cyclo protocol; Carmustine; Cyclophosphamide; Cytarabine; Doxorubicin; Etoposide; Melphalan; Prednisone; Vincristine; 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, B-Cell

Intervention Hierarchy (Ancestors)

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; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• David C. Linch

  University College London Hospitals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2004
• Study Start: January 1, 1993
• Last Updated: September 20, 2013

Record last verified: 2007-05

Locations

CZ (1); GB (66); NO (3); DK (2)