Condition category
Haematological Disorders
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
02/09/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LCH 9605

Study information

Scientific title

Acronym

Study hypothesis

To compare intensification of treatment with an improved outcome.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2002

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

193

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, United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

UK Co-ordinating Committee for Cancer Research (UKCCCR)

Sponsor details

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

Sponsor type

Government

Website

Funders

Funder type

Research organisation

Funder name

Children's Cancer Research Institute (Austria)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18089850

Publication citations

  1. Results

    Gadner H, Grois N, Pötschger U, Minkov M, Aricò M, Braier J, Broadbent V, Donadieu J, Henter JI, McCarter R, Ladisch S, , Improved outcome in multisystem Langerhans cell histiocytosis is associated with therapy intensification., Blood, 2008, 111, 5, 2556-2562, doi: 10.1182/blood-2007-08-106211.

Additional files

Editorial Notes