Condition category
Cancer
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
31/03/2009
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 F Hill

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G8223452

Study information

Scientific title

Acronym

UKALL XI (92)

Study hypothesis

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

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

Leukaemia

Intervention

Central Nervous System (CNS) directed chemotherapy/control

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Disease-free survival, CNS disease eradication, relapse rates, psychometric test results.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1990

Overall trial end date

31/12/1997

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

2,090 children were recruited

Participant exclusion criteria

Children with B-ALL and those under 1 year

Recruitment start date

01/01/1990

Recruitment end date

31/12/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Children's Hospital
Birmingham
B16 8ET
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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:
1. http://www.ncbi.nlm.nih.gov/pubmed/11328289
2. http://www.ncbi.nlm.nih.gov/pubmed/14675406
3. http://www.ncbi.nlm.nih.gov/pubmed/11813173

Publication citations

  1. Hann I, Vora A, Harrison G, Harrison C, Eden O, Hill F, Gibson B, Richards S, , Determinants of outcome after intensified therapy of childhood lymphoblastic leukaemia: results from Medical Research Council United Kingdom acute lymphoblastic leukaemia XI protocol., Br. J. Haematol., 2001, 113, 1, 103-114.

  2. Hill FG, Richards S, Gibson B, Hann I, Lilleyman J, Kinsey S, Mitchell C, Harrison CJ, Eden OB, , Successful treatment without cranial radiotherapy of children receiving intensified chemotherapy for acute lymphoblastic leukaemia: results of the risk-stratified randomized central nervous system treatment trial MRC UKALL XI (ISRC TN 16757172)., Br. J. Haematol., 2004, 124, 1, 33-46.

  3. Little MA, Morland B, Chisholm J, Hole A, Shankar A, Devine T, Easlea D, Meyer LC, Pinkerton CR, A randomised study of prophylactic G-CSF following MRC UKALL XI intensification regimen in childhood ALL and T-NHL., Med. Pediatr. Oncol., 2002, 38, 2, 98-103.

Additional files

Editorial Notes