International protocol for the treatment of childhood anaplastic large cell lymphoma (ALCL)

ISRCTN	ISRCTN98249374
DOI	https://doi.org/10.1186/ISRCTN98249374
ClinicalTrials.gov number	NCT00006455
Secondary identifying numbers	NHL 2000/06

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Denise Williams
Scientific

Cambridge University Hospitals NHS Foundation Trust
Children's Service
Box No 181
Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Phone	+44 (0)1223 216 878
Email	denise.williams@addenbrookes.nhs

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	International protocol for the treatment of childhood anaplastic large cell lymphoma (ALCL)
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	MTX, vinblastine
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/04/2000
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Child
Upper age limit	22 Years
Sex	Both
Target number of participants	40
Key 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
Key exclusion criteria	Not applicable
Date of first enrolment	01/04/2000
Date of final enrolment	31/12/2006

Cambridge University Hospitals NHS Foundation Trust

Cambridge
CB2 2QQ
United Kingdom

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

United Kingdom Children's Cancer Study Group (UKCCSG)

No information available

Intention to publish date
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

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Plain English results			No	Yes
Results article	results	01/09/2010	Yes	No
Results article	results	26/05/2011	Yes	No
Results article	results	01/07/2011	Yes	No

19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)