Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
27/02/2015
Prospective/Retrospective
Retrospectively 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 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

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

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

Publication citations

Additional files

Editorial Notes