| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN13327255 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | MRC UKALL R1 |
| Public title | Medical Research Council Acute Lymphoblastic Leukaemia Trial in Children UKALL R1 |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Leukaemia (acute) |
| Study hypothesis | Not provided at time of registration. |
| Design/methodology | Randomised controlled trial. |
| Research ethics review | Local research ethics committee approval. |
| Countries of trial | United Kingdom
|
| Participants - inclusion criteria | 1. Children under the age of 25 years at original diagnosis with first relapse of ALL at any site from previous UKALL trials or pilot studies
2. Multiple relapsed patients are excluded
3. Patients with prior history of toxicity or organ damage such that completion of the protocol is felt unlikely at the outset are to be excluded
4. Patients with Central Nervous System (CNS) relapse must have had prior radiotherapy |
| Participants - exclusion criteria | Not provided at time of registration. |
| Patient information material |
|
| Anticipated start date | 01/02/1991 |
| Anticipated end date | 30/04/1995 |
| Status of trial | Completed |
| Target number of participants | 256 patients were recruited. |
| Interventions | INDUCTION THERAPY:
All patients receive induction chemotherapy with allopurinol, dexamethasone, vincristine, aspariganase and etoposide plus intrathecal methotrexate, cystarabine and hydrocortisone.
CONSOLIDATION THERAPY:
Patients receive consolidation therapy with etoposide, cytarabine and intrathecal methotrexate followed by dexamethosone, asparaginase, epirubicin and vincristine then thioguanine, cytarabine, cyclophosphamide and intrathecal methotrexate.
CONTINUATION THERAPY:
Following consolidation patients are treated according to their initial randomisation:
1. Regimen A: A marrow-ablative regimen of cyclophosphamide and allopurin plus total body irradiation followed by autologous Bone Marrow Transplant (BMT) or allogenic BMT.
2. Regimen B: High dose methotrexate followed by continuation treatment with prednisolone, vincristine, mercaptopurine, methotrexate, thioguanine, etoposide, cytarabine, cyclophosphamide and intrathecal methotrexate. The duration of therapy is eight cycles each taking 9 weeks. |
| Primary outcome measure(s) | Not provided at time of registration. |
| Secondary outcome measure(s) | Not provided at time of registration. |
| Publications | Results: http://annonc.oxfordjournals.org/cgi/content/abstract/11/8/999?ijkey=049ccac2826d37f0ab3a3bd028d89ff743f610b4 |
| Sources of funding | 1. Medical Research Council (UK)
2. European Organisation for Research and Treatment of Cancer (EORTC) |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent
London
United Kingdom
W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.ac.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 | ISRCTN13327255 |
| Date last extracted from ISRCTN register | 17/04/2008 |
