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| ID | Type | Description | Link |
|---|---|---|---|
| UON-SHIELD | Other Identifier | Sponsor | |
| EU-20346 | Other Identifier | Sponsor |
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RATIONALE: Drugs used in chemotherapy, such as vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells.
PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating older patients with previously untreated Hodgkin's lymphoma.
OBJECTIVES:
Primary
OUTLINE: This is an open-label, multicenter study.
Patients are followed monthly for 3 months, every 3 months for 6 months, and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 36 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate |
|
| Registration | No Intervention | Registration, without treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bleomycin sulfate | Biological | Treatment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival by routine imaging | 6 month intervals |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival by routine imaging | 5 years |
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Inclusion criteria:
Histologically confirmed classical Hodgkin Lymphoma (HL). No previous treatment for HL. Age ≥ 60. "Non fragile" patient (see Appendix 1) i.e. patient's mental and physical status must be sufficient to withstand the treatment described.
No concomitant neoplasia requiring treatment or known HIV infection. Written informed consent.
Exclusion criteria:
Nodular lymphocyte predominance Hodgkin Lymphoma (NLPHL) Age <60. Patient previously treated for HL. Known HIV infection or concomitant neoplasia. "Fragile patient" (see Appendix 1) or significant abnormality of another system (pulmonary, cardiac, renal, and hepatic) which is a contraindication to full dose chemotherapy.
Unable to give informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Stephen J. Proctor, MD | University of Newcastle Upon-Tyne | Study Chair |
| Helen H. Lucraft, MD | Northern Centre for Cancer Treatment at Newcastle General Hospital | Study Director |
| Katrina M. Wood, MD | Sir James Spence Institute of Child Health at Royal Victoria Infirmary | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universitaetsklinik I at the University of Cologne | Cologne | D-50924 | Germany | |||
| Wansbeck General Hospital |
No IPD were shared, nor will be, for this trial.
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| cyclophosphamide | Drug | Treatment |
|
|
| etoposide | Drug | Treatment |
|
|
| mitoxantrone hydrochloride | Drug | Treatment |
|
|
| prednisolone | Drug | Treatment |
|
|
| procarbazine hydrochloride | Drug | Treatment |
|
|
| vinblastine sulfate | Drug | Treatment |
|
|
| Ashington |
| England |
| NE63 9JJ |
| United Kingdom |
| Basingstoke and North Hampshire NHS Foundation Trust | Basingstoke | England | RG24 9NA | United Kingdom |
| Royal United Hospital | Bath | England | BA1 3NG | United Kingdom |
| Good Hope Hospital | Birmingham | England | B75 7RR | United Kingdom |
| Blackpool Victoria Hospital | Blackpool | England | FY3 8NR | United Kingdom |
| Royal Bournemouth Hospital | Bournemouth | England | BH7 7DW | United Kingdom |
| Bradford Royal Infirmary | Bradford | England | BD9 6RJ | United Kingdom |
| Kent and Canterbury Hospital | Canterbury | England | CT1 3NG | United Kingdom |
| Cumberland Infirmary | Carlisle | England | CA2 7HY | United Kingdom |
| Saint Richards Hospital | Chichester | England | P019 4SE | United Kingdom |
| University Hospital of North Durham | Durham | England | DH1 5TW | United Kingdom |
| Queen Elizabeth Hospital | Gateshead-Tyne and Wear | England | NE9 6SX | United Kingdom |
| Medway Maritime Hospital | Gillingham Kent | England | ME7 5NY | United Kingdom |
| Diana Princess of Wales Hospital | Grimsby | England | DN33 2BA | United Kingdom |
| Harrogate District Hospital | Harrogate | England | HG2 7SX | United Kingdom |
| Hull Royal Infirmary | Hull | England | HU3 2KZ | United Kingdom |
| Ipswich Hospital | Ipswich | England | IP4 5PD | United Kingdom |
| Airedale General Hospital | Keighley | England | BD20 6TD | United Kingdom |
| Kettering General Hosptial | Kettering, Northants | England | NNI6 8UZ | United Kingdom |
| Leeds General Infirmary | Leeds | England | LS1 3EX | United Kingdom |
| Leicester Royal Infirmary | Leicester | England | LE1 5WW | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | England | L7 8XP | United Kingdom |
| University College Hospital - London | London | England | NW1 2PG | United Kingdom |
| Maidstone Hospital | Maidstone | England | ME16 9QQ | United Kingdom |
| Manchester Royal Infirmary | Manchester | England | M13 9WL | United Kingdom |
| Christie Hospital | Manchester | England | M20 4BX | United Kingdom |
| Trafford General Hospital | Manchester | England | M31 3SL | United Kingdom |
| James Cook University Hospital | Middlesbrough | England | TS4 3BW | United Kingdom |
| University of Newcastle-Upon-Tyne Northern Institute for Cancer Research | Newcastle upon Tyne | England | NE2 4HH | United Kingdom |
| Northern Centre for Cancer Treatment at Newcastle General Hospital | Newcastle upon Tyne | England | NE4 6BE | United Kingdom |
| North Tyneside Hospital | North Shields | England | NE29 8NH | United Kingdom |
| Northampton General Hospital | Northampton | England | NN1 5BD | United Kingdom |
| Mount Vernon Cancer Centre at Mount Vernon Hospital | Northwood | England | HA6 2RN | United Kingdom |
| Dorset Cancer Centre | Poole Dorset | England | BH15 2JB | United Kingdom |
| Pembury Hospital | Royal Tunbridge Wells, Kent | England | TN2 4QJ | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | England | S1O 2JF | United Kingdom |
| Wexham Park Hospital | Slough, Berkshire | England | SL2 4HL | United Kingdom |
| South Tyneside District Hospital | South Shields | England | NE34 0PL | United Kingdom |
| Southampton General Hospital | Southampton | England | SO16 6YD | United Kingdom |
| Staffordshire General Hospital | Stafford | England | ST16 3SA | United Kingdom |
| University Hospital of North Staffordshire | Stoke-On-Trent Staffs | England | ST4 6QG | United Kingdom |
| Sunderland Royal Hospital | Sunderland | England | SR4 7TP | United Kingdom |
| Royal Cornwall Hospital | Truro, Cornwall | England | TR1 3LJ | United Kingdom |
| West Cumberland Hospital | Whitehaven | England | CA28 8JG | United Kingdom |
| Cancer Care Centre at York Hospital | York | England | Y031 8HE | United Kingdom |
| Aberdeen Royal Infirmary | Aberdeen | Scotland | AB25 2ZN | United Kingdom |
| Monklands General Hospital | Airdrie | Scotland | ML6 0JF | United Kingdom |
| Edinburgh Cancer Centre at Western General Hospital | Edinburgh | Scotland | EH4 2XU | United Kingdom |
| Western Infirmary | Glasgow | Scotland | G11 6NT | United Kingdom |
| Raigmore Hospital | Inverness | Scotland | 1V2 3UJ | United Kingdom |
| Royal Alexandra Hospital | Paisley | Scotland | United Kingdom |
| Wishaw General Hospital | Wishaw | Scotland | ML2 0DP | United Kingdom |
| Barnet General Hospital | Barnet, Hertfordshire | EN5 3DJ | United Kingdom |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| 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 |
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| ID | Term |
|---|---|
| D001761 | Bleomycin |
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| C061400 | etoposide phosphate |
| D008942 | Mitoxantrone |
| D011239 | Prednisolone |
| D008775 | Methylprednisolone |
| C009022 | prednisolone phosphate |
| D011344 | Procarbazine |
| D014747 | Vinblastine |
| 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 |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011809 | Quinones |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| 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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