Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
20/06/2012
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 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 measures

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

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

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Government

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

2000 results in http://annonc.oxfordjournals.org/cgi/content/abstract/11/8/999?ijkey=049ccac2826d37f0ab3a3bd028d89ff743f610b4

Publication citations

Additional files

Editorial Notes