Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MRC UKALL R1
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration.
Ethics approval
Local research ethics committee approval.
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 (acute)
Intervention
INDUCTION THERAPY:
All patients receive induction chemotherapy with allopurinol, dexamethasone, vincristine, aspariganase and etoposide plus intrathecal methotrexate, cystarabine and hydrocortisone.
CONSOLIDATION THERAPY:
Patients receive consolidation therapy with etoposide, cytarabine and intrathecal methotrexate followed by dexamethosone, asparaginase, epirubicin and vincristine then thioguanine, cytarabine, cyclophosphamide and intrathecal methotrexate.
CONTINUATION THERAPY:
Following consolidation patients are treated according to their initial randomisation:
1. Regimen A: A marrow-ablative regimen of cyclophosphamide and allopurin plus total body irradiation followed by autologous Bone Marrow Transplant (BMT) or allogenic BMT.
2. Regimen B: High dose methotrexate followed by continuation treatment with prednisolone, vincristine, mercaptopurine, methotrexate, thioguanine, etoposide, cytarabine, cyclophosphamide and intrathecal methotrexate. The duration of therapy is eight cycles each taking 9 weeks.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/02/1991
Overall trial end date
30/04/1995
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children under the age of 25 years at original diagnosis with first relapse of ALL at any site from previous UKALL trials or pilot studies
2. Multiple relapsed patients are excluded
3. Patients with prior history of toxicity or organ damage such that completion of the protocol is felt unlikely at the outset are to be excluded
4. Patients with Central Nervous System (CNS) relapse must have had prior radiotherapy
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
256 patients were recruited.
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/02/1991
Recruitment end date
30/04/1995
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
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
Government
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Funder name
European Organisation for Research and Treatment of Cancer (EORTC)
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
Basic results (scientific)
Publication list
2000 results in http://annonc.oxfordjournals.org/cgi/content/abstract/11/8/999?ijkey=049ccac2826d37f0ab3a3bd028d89ff743f610b4