Medical Research Council Adult Acute Lymphoblastic Leukaemia Trial UKALL XA

ISRCTN	ISRCTN35362654
DOI	https://doi.org/10.1186/ISRCTN35362654
Secondary identifying numbers	MRC UKALL XA

Submission date: 19/08/2002
Registration date: 19/08/2002
Last edited: 07/06/2012

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 - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	Not provided at time of registration.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	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
Primary outcome measure	Not provided at time of registration.
Secondary outcome measures	Not provided at time of registration.
Overall study start date	01/01/1985
Completion date	31/12/1992

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	Added as of 29/06/2007: 618
Key inclusion criteria	1. Newly diagnosed ALL 2. Aged >25 years
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/01/1985
Date of final enrolment	31/12/1992

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

UKCCCR Register Co-ordinator

London
NW1 2DA
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

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/1997		Yes	No