Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
07/06/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

Additional files

Editorial Notes