Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MRC UKALL XA
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration.
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
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Leukaemia (acute)
Intervention
All patients receive induction, central nervous system (CNS) prophylaxis and maintenance.
Patients are randomised to one of four treatment arms:
1. Arm A: Early intensification therapy to be given immediately after induction and before CNS prophylaxis.
2. Arm B: Late intensification therapy to be given following cranial radiotherapy at week 20 of maintenance.
3. Arm C: Intensification therapy to be given both immediately after induction and following cranial radiotherapy at week 20 of maintenance.
4. Arm D: No intensification therapy.
INDUCTION: Chemotherapy with vincristine, prednisolone, asparaginase, daunorubicin and intrathecal methotrexate.
INTENSIFICATION: Intensification therapy with vincristine, prendisolone, daunorubicin, thioguanine, etoposide, cytosine arabinoside and intrathecal methotrexate.
CNS PROPHYLAXIS: Cranial radiotherapy, intrathecal methotrexate plus mercaptopurine.
MAINTENANCE: Maintenance therapy consisting of daily mercaptopurine, weekly methotrexate, monthly vincristine plus prednisolone. Treatment to be given for total of two years following complete remission.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/01/1985
Overall trial end date
31/12/1992
Reason abandoned
Eligibility
Participant inclusion criteria
1. Newly diagnosed ALL
2. Aged >25 years
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Added as of 29/06/2007: 618
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/01/1985
Recruitment end date
31/12/1992
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
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
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
1997 results in http://www.ncbi.nlm.nih.gov/pubmed/9359507
Publication citations
-
Results
Durrant IJ, Prentice HG, Richards SM, Intensification of treatment for adults with acute lymphoblastic leukaemia: results of U.K. Medical Research Council randomized trial UKALL XA. Medical Research Council Working Party on Leukaemia in Adults., Br. J. Haematol., 1997, 99, 1, 84-92.