Langerhans cell histiocytosis (LCH): treatment protocol of the first international study
| ISRCTN | ISRCTN97375227 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97375227 |
| Protocol serial number | LCH 9103 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funders | Cancer Research UK, United Kingdom Children's Cancer Study Group (UKCCSG) |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 01/02/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Lymphoma (non-Hodgkin's) |
| Intervention | 1. Regimen A: Chemotherapy, vinblastine with high dose methyl prednisolone 2. Regimen B: Chemotherapy, etoposide with high dose methyl prednisolone |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Chemotherapy drugs |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 18 Years |
| Sex | |
| Key inclusion criteria | 1. Definitive diagnosis of multi-system Langerhans cell histocytosis 2. Age under 18 years 3. No prior treatment for Langerhans cell histocytosis |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1991 |
| Date of final enrolment | 31/12/1999 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2001 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |