Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
04/10/2007
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 PJ Darbyshire

ORCID ID

Contact details

The Children's Hospital
Ladywood Middleway
Birmingham
B16 8ET
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G8223452

Study information

Scientific title

Acronym

UKALL R2

Study hypothesis

To compare continuing chemotherapy with unrelated donor BMT in relapsed childhood ALL following a common re-induction and consolidation regimen.

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

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

Acute Lymphoblastic Leukaemia

Intervention

Continuing chemotherapy/unrelated donor BMT

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Survival, disease free survival

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/1995

Overall trial end date

30/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

They are children under 15 years at original diagnosis and treated on UKALL trials or pilot studies with first relapse less than 4 years from the start of treatment of ALL at any site and no suitable related bone marrow treatment (BMT) donor is available

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

200 - Closed to recruitment - in long term follow-up

Participant exclusion criteria

1. They are multiply relapsed patients
2. They have a prior history of toxicity or organ damage such that completion of the protocol is felt unlikely at the outset
3. They have had an isolated CNS or testicular relapse more than 6 months off treatment.

Recruitment start date

01/02/1995

Recruitment end date

30/09/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Children's Hospital
Birmingham
B16 8ET
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

UK Medical Research Council

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

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15982346

Publication citations

  1. Results

    Roy A, Cargill A, Love S, Moorman AV, Stoneham S, Lim A, Darbyshire PJ, Lancaster D, Hann I, Eden T, Saha V, Outcome after first relapse in childhood acute lymphoblastic leukaemia - lessons from the United Kingdom R2 trial., Br. J. Haematol., 2005, 130, 1, 67-75, doi: 10.1111/j.1365-2141.2005.05572.x.

Additional files

Editorial Notes