Clinical trial NCT00003578: High Dose Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-01-27
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Prague (Praha)
country: Czech Republic
facility: Charles University Hospital
city: Aarhus
country: Denmark
facility: Aarhus Amtssygehus
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Oslo
country: Norway
facility: Norwegian Radium Hospital
city: Oslo
country: Norway
facility: Ullevall Hospital
city: Tromso
country: Norway
facility: University of Tromso
city: Aylesbury-Buckinghamshire
country: United Kingdom
facility: Stoke Mandeville Hospital
state: England
city: Bath
country: United Kingdom
facility: Royal United Hospital
state: England
city: Birmingham
country: United Kingdom
facility: City Hospital - Birmingham
state: England
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands and Solihull NHS Trust (Teaching)
state: England
city: Bristol
country: United Kingdom
facility: Southmead Hospital
state: England
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
state: England
city: Burton-upon-Trent
country: United Kingdom
facility: Queen's Hospital, Burton
state: England
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
state: England
city: Cheltenham
country: United Kingdom
facility: Cheltenham General Hospital
state: England
city: Chester
country: United Kingdom
facility: Countess of Chester Hospital
state: England
city: Derby
country: United Kingdom
facility: Derbyshire Royal Infirmary
state: England
city: Hampstead, London
country: United Kingdom
facility: Royal Free Hospital
state: England
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
state: England
city: Huddersfield, West Yorks
country: United Kingdom
facility: Huddersfield Royal Infirmary
state: England
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital NHS Trust
state: England
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospital Trust
state: England
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
state: England
city: Liverpool
country: United Kingdom
facility: Royal Liverpool and Broadgreen Hospitals
state: England
city: London
country: United Kingdom
facility: Whipps Cross Hospital
state: England
city: London
country: United Kingdom
facility: Saint Bartholomew's Hospital
state: England
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
state: England
city: London
country: United Kingdom
facility: St. Georges Hospital Medical School
state: England
city: London
country: United Kingdom
facility: University College London Medical School
state: England
city: London
country: United Kingdom
facility: University College London
state: England
city: London
country: United Kingdom
facility: Charing Cross Hospital
state: England
city: London
country: United Kingdom
facility: Middlesex Hospital- Meyerstein Institute
state: England
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital
state: England
city: Manchester
country: United Kingdom
facility: Christie Hospital N.H.S. Trust
state: England
city: Merseyside
country: United Kingdom
facility: Clatterbridge Centre for Oncology NHS Trust
state: England
city: Merseyside
country: United Kingdom
facility: Southport and Formby District General Hospital
state: England
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes General Hospital
state: England
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital NHS Trust
state: England
city: Oxford
country: United Kingdom
facility: Oxford Radcliffe Hospital
state: England
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
state: England
city: Romford
country: United Kingdom
facility: Oldchurch Hospital
state: England
city: Royal Tunbridge Wells, Kent
country: United Kingdom
facility: Pembury Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals
state: England
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital
state: England
city: Southampton
country: United Kingdom
facility: Royal South Hants Hospital
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: England
city: Torquay Devon
country: United Kingdom
facility: Torbay Hospital
state: England
city: Uxbridge
country: United Kingdom
facility: Hillingdon Hospital
state: England
city: West Bromwich
country: United Kingdom
facility: Sandwell District General Hospital
state: England
city: West Midlands
country: United Kingdom
facility: Good Hope Hospital Trust
state: England
city: West Yorks
country: United Kingdom
facility: Pontefract General Infirmary
state: England
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
state: England
city: Belfast
country: United Kingdom
facility: Belfast City Hospital Trust
state: Northern Ireland
city: Londonderry
country: United Kingdom
facility: Altnagelvin Area Hospital
state: Northern Ireland
city: Bangor
country: United Kingdom
facility: Ysbyty Gwynedd
state: Wales
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Carluke UK
country: United Kingdom
facility: Law Hospital
city: Chichester
country: United Kingdom
facility: Saint Richards Hospital
city: Enfield
country: United Kingdom
facility: Chase Farm Hospital
city: Epsom Surrey
country: United Kingdom
facility: Epsom General Hospital
city: Grantham
country: United Kingdom
facility: Grantham and District Hospital
city: Ilford, Essex
country: United Kingdom
facility: King George Hospital
city: King's Lynn
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Liverpool
country: United Kingdom
facility: Walton General Hospital
city: London
country: United Kingdom
facility: Newham General Hospital
city: London
country: United Kingdom
facility: St. Mary's Hospital
city: Middlesex
country: United Kingdom
facility: West Middlesex Hospital
city: Redhill
country: United Kingdom
facility: East Surrey Hospital
city: Rotherham
country: United Kingdom
facility: Rotherham District General Hospital-NHS Trust
city: Scunthorpe
country: United Kingdom
facility: Scunthorpe General Hospital
city: Stafford
country: United Kingdom
facility: Staffordshire General Hospital
Study officials:
affiliation: University College London Hospitals
name: David C. Linch
role: STUDY_CHAIR
References: