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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000067900 | Registry Identifier | PDQ (Physician Data Query) | |
| EU-99052 |
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying two regimens of combination chemotherapy and comparing how well they work in treating patients with aggressive non-Hodgkin's lymphoma.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
Patients are followed at 4 weeks, then every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 310 patients (155 per arm) will be accrued for this study over 5 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bleomycin sulfate | Biological | |||
| CHOP regimen | Drug | |||
| cyclophosphamide | Drug | |||
| doxorubicin hydrochloride | Drug | |||
| etoposide | Drug | |||
| mitoxantrone hydrochloride | Drug | |||
| prednisolone | Drug | |||
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival in patients treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP) |
| Measure | Description | Time Frame |
|---|---|---|
| Failure-free survival, disease specific survival, relapse-free survival, death due to toxicity, response rate, and toxicity at 4 years |
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DISEASE CHARACTERISTICS:
Histologically proven previously untreated bulky stage IA or stage IB-IV aggressive non-Hodgkin's lymphoma of 1 of the following types:
Working formulation:
REAL classification:
Measurable or evaluable disease
Good prognosis defined as no more than one of the following:
No lymphoblastic or Burkitt's lymphoma
No CNS involvement
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Ruth Pettengell, MD | St. George's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stoke Mandeville Hospital | Aylesbury-Buckinghamshire | England | HP21 8AL | United Kingdom | ||
| Horton Hospital |
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| vincristine sulfate |
| Drug |
| Banbury |
| England |
| OX16 9AL |
| United Kingdom |
| Basildon University Hospital | Basildon | England | SS16 5NL | United Kingdom |
| Birmingham Heartlands Hospital | Birmingham | England | B9 5SS | United Kingdom |
| Bradford Hospitals NHS Trust | Bradford | England | BD9 6RJ | United Kingdom |
| Bristol Haematology and Oncology Centre | Bristol | England | BS2 8ED | United Kingdom |
| Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust | Cambridge | England | CB2 2QQ | United Kingdom |
| Cheltenham General Hospital | Cheltenham | England | GL53 7AN | United Kingdom |
| Countess of Chester Hospital NHS Foundation Trust | Chester | England | CH2 1UL | United Kingdom |
| Saint Richards Hospital | Chichester | England | P019 4SE | United Kingdom |
| Essex County Hospital | Colchester | England | C03 3NB | United Kingdom |
| Walsgrave Hospital | Coventry | England | CV2 2DX | United Kingdom |
| Russells Hall Hospital | Dudley | England | DY1 2HQ | United Kingdom |
| Chase Farm Hospital | Enfield | England | EN 28 JL | United Kingdom |
| Medway Maritime Hospital | Gillingham Kent | England | ME7 5NY | United Kingdom |
| Hull Royal Infirmary | Hull | England | HU3 2KZ | United Kingdom |
| Hinchingbrooke Hospital | Huntingdon | England | PE18 6NT | United Kingdom |
| Queen Elizabeth Hospital | Kings Lynn | England | PE30 4ET | United Kingdom |
| Leicester Royal Infirmary | Leicester | England | LE1 5WW | United Kingdom |
| Royal Liverpool and Broadgreen Hospitals NHS Trust | Liverpool | England | L7 8XP | United Kingdom |
| Aintree University Hospital | Liverpool | England | L9 7AL | United Kingdom |
| Saint Bartholomew's Hospital | London | England | EC1A 7BE | United Kingdom |
| St. Thomas' Hospital | London | England | SE1 7EH | United Kingdom |
| St. George's Hospital | London | England | SW17 0QT | United Kingdom |
| Middlesex Hospital | London | England | WC1E 6HX | United Kingdom |
| Clatterbridge Centre for Oncology NHS Trust | Merseyside | England | CH63 4JY | United Kingdom |
| Norfolk and Norwich University Hospital | Norwich | England | NR4 7UY | United Kingdom |
| Nottingham City Hospital NHS Trust | Nottingham | England | NG5 1PB | United Kingdom |
| Oxford Radcliffe Hospital | Oxford | England | 0X3 9DU | United Kingdom |
| Pontefract General Infirmary | Pontefract West Yorkshire | England | WF8 1PL | United Kingdom |
| Oldchurch Hospital | Romford | England | RM7 OBE | United Kingdom |
| Scunthorpe General Hospital | Scunthorpe | England | DN15 7BH | United Kingdom |
| Cancer Research Centre at Weston Park Hospital | Sheffield | England | S1O 2SJ | United Kingdom |
| Southampton University Hospital NHS Trust | Southampton | England | SO16 6YD | United Kingdom |
| University Hospital of North Staffordshire | Stoke-On-Trent Staffs | England | ST4 6QG | United Kingdom |
| East Surrey Hospital | Surrey | England | RH1 5RH | United Kingdom |
| Royal Marsden NHS Foundation Trust - Surrey | Sutton | England | SM2 5PT | United Kingdom |
| Sandwell General Hospital | West Bromwich | England | B71 4HJ | United Kingdom |
| Cancer Care Centre at York Hospital | York | England | Y031 8HE | United Kingdom |
| Centre for Cancer Research and Cell Biology at Belfast City Hospital | Belfast | Northern Ireland | BT9 7AB | United Kingdom |
| Aberdeen Royal Infirmary | Aberdeen | Scotland | AB25 2ZN | United Kingdom |
| Pinderfields Hospital NHS Trust | Wakefield | Scotland | WF1 4DG | United Kingdom |
| Ysbyty Gwynedd | Bangor | Wales | LL57 2PW | United Kingdom |
| University Hospital of Wales | Cardiff | Wales | CF14 4XN | United Kingdom |
| Glan Clywd District General Hospital | Rhyl, Denbighshire | Wales | LL 18 5UJ | United Kingdom |
| Mount Vernon Cancer Centre at Mount Vernon Hospital | Rhyl, Denbighshire | Wales | LL 18 5UJ | 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 |
|---|---|
| D001761 | Bleomycin |
| C036337 | VAP-cyclo protocol |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D005047 | Etoposide |
| D008942 | Mitoxantrone |
| D011239 | Prednisolone |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011809 | Quinones |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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