LCH-II Langerhans cell histiocytosis: treatment protocol of the second international study

ISRCTN ISRCTN57679341
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

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study hypothesisTo compare intensification of treatment with an improved outcome.
Ethics approval(s)Not provided at time of registration
ConditionLangerhans cell histiocytosis
InterventionRisk 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2002
Overall study end date31/12/2007

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit18 Years
SexBoth
Target number of participants193
Participant inclusion criteria1. 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 criteriaDoes not comply with above criteria
Recruitment start date01/01/2002
Recruitment end date31/12/2007

Locations

Countries of recruitment

  • Austria
  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

UK Co-ordinating Committee for Cancer Research (UKCCCR)
Government

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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