Lymphoma Clinical Trial
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
| Verified date | May 2007 |
| Source | National Cancer Institute (NCI) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Federal Government |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 500 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Czech Republic | Charles University Hospital | Prague (Praha) | |
| Denmark | Aarhus Amtssygehus | Aarhus | |
| Denmark | Rigshospitalet | Copenhagen | |
| Norway | Norwegian Radium Hospital | Oslo | |
| Norway | Ullevall Hospital | Oslo | |
| Norway | University of Tromso | Tromso | |
| United Kingdom | Stoke Mandeville Hospital | Aylesbury-Buckinghamshire | England |
| United Kingdom | Ysbyty Gwynedd | Bangor | Wales |
| United Kingdom | Royal United Hospital | Bath | England |
| United Kingdom | Belfast City Hospital Trust | Belfast | Northern Ireland |
| United Kingdom | Birmingham Heartlands and Solihull NHS Trust (Teaching) | Birmingham | England |
| United Kingdom | City Hospital - Birmingham | Birmingham | England |
| United Kingdom | Royal Bournemouth Hospital | Bournemouth | |
| United Kingdom | Bristol Haematology and Oncology Centre | Bristol | England |
| United Kingdom | Southmead Hospital | Bristol | England |
| United Kingdom | Queen's Hospital, Burton | Burton-upon-Trent | England |
| United Kingdom | Kent and Canterbury Hospital | Canterbury | England |
| United Kingdom | Law Hospital | Carluke UK | |
| United Kingdom | Cheltenham General Hospital | Cheltenham | England |
| United Kingdom | Countess of Chester Hospital | Chester | England |
| United Kingdom | Saint Richards Hospital | Chichester | |
| United Kingdom | Derbyshire Royal Infirmary | Derby | England |
| United Kingdom | Chase Farm Hospital | Enfield | |
| United Kingdom | Epsom General Hospital | Epsom Surrey | |
| United Kingdom | Grantham and District Hospital | Grantham | |
| United Kingdom | Royal Free Hospital | Hampstead, London | England |
| United Kingdom | Northwick Park Hospital | Harrow | England |
| United Kingdom | Huddersfield Royal Infirmary | Huddersfield, West Yorks | England |
| United Kingdom | King George Hospital | Ilford, Essex | |
| United Kingdom | Ipswich Hospital NHS Trust | Ipswich | England |
| United Kingdom | Queen Elizabeth Hospital | King's Lynn | |
| United Kingdom | Leeds Teaching Hospital Trust | Leeds | England |
| United Kingdom | University Hospitals of Leicester | Leicester | England |
| United Kingdom | Royal Liverpool and Broadgreen Hospitals | Liverpool | England |
| United Kingdom | Walton General Hospital | Liverpool | |
| United Kingdom | Charing Cross Hospital | London | England |
| United Kingdom | Middlesex Hospital- Meyerstein Institute | London | England |
| United Kingdom | Newham General Hospital | London | |
| United Kingdom | Saint Bartholomew's Hospital | London | England |
| United Kingdom | St. Bartholomew's Hospital | London | England |
| United Kingdom | St. Georges Hospital Medical School | London | England |
| United Kingdom | St. Mary's Hospital | London | |
| United Kingdom | University College London | London | England |
| United Kingdom | University College London Medical School | London | England |
| United Kingdom | Whipps Cross Hospital | London | England |
| United Kingdom | Altnagelvin Area Hospital | Londonderry | Northern Ireland |
| United Kingdom | Maidstone Hospital | Maidstone | England |
| United Kingdom | Christie Hospital N.H.S. Trust | Manchester | England |
| United Kingdom | Clatterbridge Centre for Oncology NHS Trust | Merseyside | England |
| United Kingdom | Southport and Formby District General Hospital | Merseyside | England |
| United Kingdom | West Middlesex Hospital | Middlesex | |
| United Kingdom | Milton Keynes General Hospital | Milton Keynes | England |
| United Kingdom | Mount Vernon Hospital | Northwood | England |
| United Kingdom | Nottingham City Hospital NHS Trust | Nottingham | England |
| United Kingdom | Oxford Radcliffe Hospital | Oxford | England |
| United Kingdom | Derriford Hospital | Plymouth | England |
| United Kingdom | East Surrey Hospital | Redhill | |
| United Kingdom | Oldchurch Hospital | Romford | England |
| United Kingdom | Rotherham District General Hospital-NHS Trust | Rotherham | |
| United Kingdom | Pembury Hospital | Royal Tunbridge Wells, Kent | England |
| United Kingdom | Scunthorpe General Hospital | Scunthorpe | |
| United Kingdom | Sheffield Teaching Hospitals | Sheffield | England |
| United Kingdom | Weston Park Hospital | Sheffield | England |
| United Kingdom | Royal South Hants Hospital | Southampton | England |
| United Kingdom | Staffordshire General Hospital | Stafford | |
| United Kingdom | Royal Marsden Hospital | Sutton | England |
| United Kingdom | Torbay Hospital | Torquay Devon | England |
| United Kingdom | Hillingdon Hospital | Uxbridge | England |
| United Kingdom | Sandwell District General Hospital | West Bromwich | England |
| United Kingdom | Good Hope Hospital Trust | West Midlands | England |
| United Kingdom | Pontefract General Infirmary | West Yorks | England |
| United Kingdom | New Cross Hospital | Wolverhampton | England |
| Lead Sponsor | Collaborator |
|---|---|
| Lymphoma Trials Office |
Czech Republic, Denmark, Norway, United Kingdom,
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