LCH-II Langerhans cell histiocytosis: treatment protocol of the second international study
| ISRCTN | ISRCTN57679341 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57679341 |
| Protocol serial number | LCH 9605 |
| Sponsor | UK Co-ordinating Committee for Cancer Research (UKCCCR) |
| Funder | Children's Cancer Research Institute (Austria) |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 02/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
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 |
| Scientific title | |
| Study objectives | To compare intensification of treatment with an improved outcome. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Langerhans cell histiocytosis |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 193 |
| Key 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 |
| Key exclusion criteria | Does not comply with above criteria |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
- Austria
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 | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/03/2008 | Yes | No |
