ISRCTN ISRCTN95257778
DOI https://doi.org/10.1186/ISRCTN95257778
Secondary identifying numbers G8223452
Submission date
06/04/2000
Registration date
06/04/2000
Last edited
04/10/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr PJ Darbyshire
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeNot Specified
Scientific title
Study acronymUKALL R2
Study objectivesTo compare continuing chemotherapy with unrelated donor BMT in relapsed childhood ALL following a common re-induction and consolidation regimen.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAcute Lymphoblastic Leukaemia
InterventionContinuing chemotherapy/unrelated donor BMT
Intervention typeOther
Primary outcome measureSurvival, disease free survival
Secondary outcome measuresNot provided at time of registration
Overall study start date01/02/1995
Completion date30/09/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants200 - Closed to recruitment - in long term follow-up
Key inclusion criteriaThey are children under 15 years at original diagnosis and treated on UKALL trials or pilot studies with first relapse less than 4 years from the start of treatment of ALL at any site and no suitable related bone marrow treatment (BMT) donor is available
Key exclusion criteria1. They are multiply relapsed patients
2. They have a prior history of toxicity or organ damage such that completion of the protocol is felt unlikely at the outset
3. They have had an isolated CNS or testicular relapse more than 6 months off treatment.
Date of first enrolment01/02/1995
Date of final enrolment30/09/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Children's Hospital
Birmingham
B16 8ET
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

UK Medical Research Council

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/07/2005 Yes No