UKALL XI (92) - Acute lymphoblastic leukaemia trial

ISRCTN	ISRCTN16757172
DOI	https://doi.org/10.1186/ISRCTN16757172
Protocol serial number	G8223452
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr F Hill
Scientific

The Children's Hospital
Ladywood Middleway
Birmingham
B16 8ET
United Kingdom

Email	none@example.com

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	UKALL XI (92) - Acute lymphoblastic leukaemia trial
Study acronym	UKALL XI (92)
Study objectives	To test if CNS disease eradication can be successfully achieved without cranial radiotherapy by using CNS directed chemotherapy, to determine whether the use of high-dose intravenous MTX as part of the CNS therapy will reduce the incidence of systematic relapse, to assess whether a third intensification block of chemotherapy effects disease free survival, to compare by psychometric testing the long term learning and neuropsychological effects of the different CNS treatments. Please note that the target number of participants was added as of 18/07/2007.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Leukaemia
Intervention	Central Nervous System (CNS) directed chemotherapy/control
Intervention type	Other
Primary outcome measure(s)	Disease-free survival, CNS disease eradication, relapse rates, psychometric test results.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/1997

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Year
Upper age limit	15 Years
Sex	All
Target sample size at registration	2090
Key inclusion criteria	They are children including those with Down's syndrome or leukaemia associated chromosome translocations over 1 year and under 15 years with newly diagnosed ALL of any immunologic subtype except B-ALL
Key exclusion criteria	Children with B-ALL and those under 1 year
Date of first enrolment	01/01/1990
Date of final enrolment	31/12/1997

The Children's Hospital

Birmingham
B16 8ET
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	01/02/2002		Yes	No
Results article	01/01/2004		Yes	No
Results article	13/10/2011	01/09/2022	Yes	No
Protocol article	01/04/2001		Yes	No

01/09/2022: Publication reference added.