Contact information
Type
Scientific
Primary contact
Dr Denise Williams
ORCID ID
Contact details
Cambridge University Hospitals NHS Foundation Trust
Children's Service
Box No 181
Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 216 878
denise.williams@addenbrookes.nhs
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00006455
Protocol/serial number
NHL 2000/06
Study information
Scientific title
International protocol for the treatment of childhood anaplastic large cell lymphoma (ALCL)
Acronym
Study hypothesis
Not provided at time of registration
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
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Lymphoma (non-Hodgkin's)
Intervention
Four arms:
Arm one: MTX (1 g/m2) over 24 hours with intrathecal
Arm two: MTX (1 g/m2) over 24 hours with intrathecal and Vinblastine for one year
Arm three: MTX (3 g/m2) over three hours without intrathecal
Arm four: MTX (3 g/m2) over three hours without intrathecal and Vinblastine for one year
Intervention type
Drug
Phase
Not Applicable
Drug names
MTX, vinblastine
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2000
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. ALCL diagnosed by local pathologist
2. Slides available for national review
3. Aged <22 years
4. No previous treatment
5. Appropriate ethical approval
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
40
Participant exclusion criteria
Not applicable
Recruitment start date
01/04/2000
Recruitment end date
31/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cambridge University Hospitals NHS Foundation Trust
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
United Kingdom Children's Cancer Study Group (UKCCSG)
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
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20679620
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21444917
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21280197