| Source of record | UK Trials |
| ISRCTN | ISRCTN57679341 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | LCH 9605 |
| Public title | LCH-II Langerhans cell histiocytosis: treatment protocol of the second international study |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Miscellaneous |
| Study hypothesis | To compare intensification of treatment with an improved outcome. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom, Austria |
| Participants - inclusion criteria | 1. Definitive diagnosis of Langerhans cell histiocytosis
2. Aged under 18 years with involvement of haematopetic system, liver, lungs or spleen or aged under 2 years
3. No prior treatment for Langerhans cell histiocytosis |
| Participants - exclusion criteria | Does not comply with above criteria |
| Patient information material |
|
| Anticipated start date | 01/01/2002 |
| Anticipated end date | 31/12/2007 |
| Status of trial | Completed |
| Target number of participants | 193 |
| Interventions | Risk group patients are randomised to either:
1. Arm A: Initial treatment with oral prednisone and vinblastine. Continuation treatment with oral 6-mercaptopurine plus pulses of oral prednisone and vinblastine.
2. Arm B: Initial treatment with oral prednisone and vinblastine. Continuation treatment with oral 6-mercaptopurine plus pulses of oral prednisone and vinblastine followed by etoposide. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Publications | Results in http://www.ncbi.nlm.nih.gov/pubmed/18089850 |
| Sources of funding | Children's Cancer Research Institute (Austria) |
| Sponsor name | UK Co-ordinating Committee for Cancer Research (UKCCCR) |
| Sponsor details | MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Sponsor telephone | +44 (0) 20 7670 4723 |
| Sponsor fax | +44 (0) 20 7670 4818 |
| Sponsor email | register@ctu.mrc.ac.uk |
| Sponsor website | http://www.ctu.mrc.ac.uk/ukcccr/home.html |
| 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 | ISRCTN57679341 |
| Date last extracted from ISRCTN register | 17/04/2008 |
