LCH-II Langerhans cell histiocytosis: treatment protocol of the second international study
ISRCTN | ISRCTN57679341 |
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DOI | https://doi.org/10.1186/ISRCTN57679341 |
Secondary identifying numbers | LCH 9605 |
- 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
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
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study hypothesis | To compare intensification of treatment with an improved outcome. |
Ethics approval(s) | Not provided at time of registration |
Condition | 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 | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/2002 |
Overall study end date | 31/12/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Upper age limit | 18 Years |
Sex | Both |
Target number of participants | 193 |
Participant 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 |
Participant exclusion criteria | Does not comply with above criteria |
Recruitment start date | 01/01/2002 |
Recruitment end date | 31/12/2007 |
Locations
Countries of recruitment
- Austria
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
UK Co-ordinating Committee for Cancer Research (UKCCCR)
Government
Government
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
https://ror.org/054225q67 |
Funders
Funder type
Research organisation
Children's Cancer Research Institute (Austria)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | Results | 01/03/2008 | Yes | No |