Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G8223452
Study information
Scientific title
Acronym
UKALL R2
Study hypothesis
To compare continuing chemotherapy with unrelated donor BMT in relapsed childhood ALL following a common re-induction and consolidation regimen.
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
Not Specified
Patient information sheet
Condition
Acute Lymphoblastic Leukaemia
Intervention
Continuing chemotherapy/unrelated donor BMT
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Survival, disease free survival
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/1995
Overall trial end date
30/09/2008
Reason abandoned
Eligibility
Participant inclusion criteria
They 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
200 - Closed to recruitment - in long term follow-up
Participant exclusion criteria
1. 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.
Recruitment start date
01/02/1995
Recruitment end date
30/09/2008
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 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
UK Medical Research Council
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
Publication citations
-
Results
Roy A, Cargill A, Love S, Moorman AV, Stoneham S, Lim A, Darbyshire PJ, Lancaster D, Hann I, Eden T, Saha V, Outcome after first relapse in childhood acute lymphoblastic leukaemia - lessons from the United Kingdom R2 trial., Br. J. Haematol., 2005, 130, 1, 67-75, doi: 10.1111/j.1365-2141.2005.05572.x.