| Source of record | UK Trials |
| ISRCTN | ISRCTN25173819 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | NHL9602 |
| Public title | Treatment of mature B-cell lymphoma/leukaemia |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Leukaemia (acute), lymphoma (non-Hodgkins) |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. B-large cell, small non-cleaved non-Hodgkin's disease or B-cell leukaemia
2. Stages I-IV
3. Aged over 6 months and under 18 years
4. No previous chemotherapy. Emergency radiotherapy or immunotherapy is permitted
5. No congenital immunodeficiency
6. No prior organ transplantation
7. No previous malignancy of any type
8. No medical contraindications to protocol treatments
9. Patients available for a minimal follow-up of 36 months |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/1998 |
| Anticipated end date | 15/06/2001 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Patients are randomised to one of four treatment arms:
1. Arm A: A single course of cyclophosphamide, vincristine, prednisolone (COP) followed by two courses of chemotherapy with cyclophosphamide, vincristine, prednisolone, adriamycin, hydrocortisone and methotrexate (COPADM) followed by cytarabine, etoposide and a third course of COPADM
2. Arm 2: A single course of COP followed by two courses of COPADM then cytarabine followed by etoposide
3. Arm C: A single course of COP followed by two courses of modified COPADM in which the dose of cyclophosphamide has been halved. Patients then receive cytarabine followed by etoposide and a third course of COPADM
4. Arm D: A single course of COP followed by two courses of modified COPADM in which the dose of cyclophosphamide has been halved. Patients then receive cytarabine followed by etoposide |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK
United Kingdom Children's Cancer Study Group (UKCCSG) |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN25173819 |
| Date last extracted from ISRCTN register | 17/04/2008 |
