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| ID | Type | Description | Link |
|---|---|---|---|
| BNLI-LY02 | |||
| EU-98039 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHOP regimen | Drug | |||
| carmustine | Drug | |||
| cyclophosphamide | Drug | |||
| cytarabine | Drug | |||
| doxorubicin hydrochloride | Drug | |||
| etoposide | Drug | |||
| melphalan | Drug | |||
| prednisone |
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
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| Name | Affiliation | Role |
|---|---|---|
| David C. Linch | University College London Hospitals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles University Hospital | Prague (Praha) | 128 08 | Czechia | |||
| Aarhus Amtssygehus |
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| Drug |
| vincristine sulfate | Drug |
| autologous bone marrow transplantation | Procedure |
| peripheral blood stem cell transplantation | Procedure |
| Aarhus |
| DK 8000 |
| Denmark |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| Norwegian Radium Hospital | Oslo | N-0310 | Norway |
| Ullevall Hospital | Oslo | N-0407 4 | Norway |
| University of Tromso | Tromsø | N-9037 | Norway |
| Stoke Mandeville Hospital | Aylesbury-Buckinghamshire | England | HP21 8AL | United Kingdom |
| Royal United Hospital | Bath | England | BA1 3NG | United Kingdom |
| City Hospital - Birmingham | Birmingham | England | B18 7QH | United Kingdom |
| Birmingham Heartlands and Solihull NHS Trust (Teaching) | Birmingham | England | B9 5SS | United Kingdom |
| Southmead Hospital | Bristol | England | BS10 5NB | United Kingdom |
| Bristol Haematology and Oncology Centre | Bristol | England | BS2 8ED | United Kingdom |
| Queen's Hospital, Burton | Burton-on-Trent | England | DE14 3QH | United Kingdom |
| Kent and Canterbury Hospital | Canterbury | England | CT2 7NR | United Kingdom |
| Cheltenham General Hospital | Cheltenham | England | GL53 7AN | United Kingdom |
| Countess of Chester Hospital | Chester | England | CH2 1UL | United Kingdom |
| Derbyshire Royal Infirmary | Derby | England | DE1 2QY | United Kingdom |
| Royal Free Hospital | Hampstead, London | England | NW3 2QG | United Kingdom |
| Northwick Park Hospital | Harrow | England | HA1 3UJ | United Kingdom |
| Huddersfield Royal Infirmary | Huddersfield, West Yorks | England | HD3 3EA | United Kingdom |
| Ipswich Hospital NHS Trust | Ipswich | England | IP4 5PD | United Kingdom |
| Leeds Teaching Hospital Trust | Leeds | England | LS1 3EX | United Kingdom |
| University Hospitals of Leicester | Leicester | England | LE1 5WW | United Kingdom |
| Royal Liverpool and Broadgreen Hospitals | Liverpool | England | L7 8XP | United Kingdom |
| Whipps Cross Hospital | London | England | E11 1NR | United Kingdom |
| Saint Bartholomew's Hospital | London | England | EC1A 7BE | United Kingdom |
| St. Bartholomew's Hospital | London | England | EC1A 7BE | United Kingdom |
| St. Georges Hospital Medical School | London | England | SW17 ORE | United Kingdom |
| University College London Medical School | London | England | W1N 8AA | United Kingdom |
| University College London | London | England | W1W 7EJ | United Kingdom |
| Charing Cross Hospital | London | England | W6 8RF | United Kingdom |
| Middlesex Hospital- Meyerstein Institute | London | England | WIT 3AA | United Kingdom |
| Maidstone Hospital | Maidstone | England | ME16 9QQ | United Kingdom |
| Christie Hospital N.H.S. Trust | Manchester | England | M20 4BX | United Kingdom |
| Clatterbridge Centre for Oncology NHS Trust | Merseyside | England | L63 4JY | United Kingdom |
| Southport and Formby District General Hospital | Merseyside | England | PR8 6NJ | United Kingdom |
| Milton Keynes General Hospital | Milton Keynes | England | MK6 5LD | United Kingdom |
| Mount Vernon Hospital | Northwood | England | HA6 2RN | United Kingdom |
| Nottingham City Hospital NHS Trust | Nottingham | England | NG5 1PB | United Kingdom |
| Oxford Radcliffe Hospital | Oxford | England | 0X3 9DU | United Kingdom |
| Derriford Hospital | Plymouth | England | PL6 8DH | United Kingdom |
| Oldchurch Hospital | Romford | England | RM7 OBE | United Kingdom |
| Pembury Hospital | Royal Tunbridge Wells, Kent | England | TN2 4QJ | United Kingdom |
| Sheffield Teaching Hospitals | Sheffield | England | S1O 2JF | United Kingdom |
| Weston Park Hospital | Sheffield | England | S1O 2SJ | United Kingdom |
| Royal South Hants Hospital | Southampton | England | SO14 0YG | United Kingdom |
| Royal Marsden Hospital | Sutton | England | SM2 5PT | United Kingdom |
| Torbay Hospital | Torquay Devon | England | TQ2 7AA | United Kingdom |
| Hillingdon Hospital | Uxbridge | England | UB8 3NN | United Kingdom |
| Sandwell District General Hospital | West Bromwich | England | United Kingdom |
| Good Hope Hospital Trust | West Midlands | England | B75 7RR | United Kingdom |
| Pontefract General Infirmary | West Yorks | England | WF8 1PL | United Kingdom |
| New Cross Hospital | Wolverhampton | England | WV10 0QP | United Kingdom |
| Belfast City Hospital Trust | Belfast | Northern Ireland | BT9 7AB | United Kingdom |
| Altnagelvin Area Hospital | Londonderry | Northern Ireland | BT47 1SB | United Kingdom |
| Ysbyty Gwynedd | Bangor | Wales | LL57 2PW | United Kingdom |
| Royal Bournemouth Hospital | Bournemouth | BH7 7DW | United Kingdom |
| Law Hospital | Carluke UK | ML8 5ER | United Kingdom |
| Saint Richards Hospital | Chichester | P019 4SE | United Kingdom |
| Chase Farm Hospital | Enfield | NG31 8DG | 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 |
| Queen Elizabeth Hospital | Kings Lynn | PE30 4ET | United Kingdom |
| Walton General Hospital | Liverpool | L9 1AE | United Kingdom |
| Newham General Hospital | London | E13 8RU | United Kingdom |
| St. Mary's Hospital | London | W2 1NY | United Kingdom |
| West Middlesex Hospital | Middlesex | N18 1QZ | United Kingdom |
| East Surrey Hospital | Redhill | RH1 5RH | United Kingdom |
| Rotherham District General Hospital-NHS Trust | Rotherham | S60 2UD | United Kingdom |
| Scunthorpe General Hospital | Scunthorpe | DN15 7BH | United Kingdom |
| Staffordshire General Hospital | Stafford | ST16 3SA | United Kingdom |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| D008228 | Lymphoma, Non-Hodgkin |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
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| ID | Term |
|---|---|
| C036337 | VAP-cyclo protocol |
| D002330 | Carmustine |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D004317 | Doxorubicin |
| D005047 | Etoposide |
| D008558 | Melphalan |
| D011241 | Prednisone |
| D014750 | Vincristine |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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