Condition category
Cancer
Date applied
01/10/2003
Date assigned
01/10/2003
Last edited
04/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Vaskar Saha

ORCID ID

Contact details

Academic Unit of Paediatric & Adolescent Oncology
University of Manchester
Wilmslow Road
Manchester
M20 4BX
United Kingdom
+44 (0)161 446 3023
vaskar.saha@manchester.ac.uk

Additional identifiers

EudraCT number

2004-000052-16

ClinicalTrials.gov number

NCT00967057

Protocol/serial number

N/A

Study information

Scientific title

An International Collaborative Trial for Relapsed and Refractory Acute Lymphoblastic Leukaemia

Acronym

ALLR3

Study hypothesis

To examine the biology of relapsed Acute Lymphoblastic Leukaemia (ALL) and improve its outcome using a combination of chemotherapy and nationally standardised approach to Haematopoietic Stem Cell Transplantation (HSCT).

Please note that as of 13/05/10 this record has been extensively updated. Ireland, Australia, New Zealand and the Netherlands have been added to the countries of recuitment. The end date of this trial has also been extended from 01/01/2010 to 31/12/2011. All other updates can be found in the relevant field with the above update date.

Please note that the primary contact has moved insitution, therefore as of 13/05/10 the contact and sponsor details have been updated. The previous sponsor and contact details are as follows.
Previous sponsor:
Barts and the London NHS Trust (UK)
Research and Development Department
3rd Floor Rutland House
42-46 New Road
Whitechapel
London
E1 2AX
United Kingdom
http://www.bartsandthelondon.org.uk

Previous contact address:
Dept of Paediatric Oncology and Haematology
1st Floor Eva Luckes House
Royal London Hospital
London
E1 1BB
United Kingdom

Ethics approval

Ethics approval received from the Multicentre Research Ethics Committee for Wales (ref: 02/9/21)

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

Relapsed and Refractory Acute Lymphoblastic Leukaemia (ALL)

Intervention

No additional procedures are required in the trial. The trial drugs have already been used in previous paediatric oncology trials for many years.

Randomisation closed December 2007

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Added 13/05/2010:
1. Evaluate Progression Free Survival (PFS) by risk group
2. Evaluate whether a minimal residual disease level (MRD) level of 10-4 is a suitable criteria at the end of induction on which to decide whether chemotherapy or stem cell transplantation (SCT) will be most beneficial to patients in the intermediate risk group.

Secondary outcome measures

Added 13/05/2010:
1. MRD as a surrogate marker for PFS
2. Randomised comparison between Mitoxantrone and Idarubicin

Overall trial start date

06/01/2003

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. All children aged 1 - 18 years who have been previously diagnosed to have acute lymphoblastic leukaemia and have either relapsed after treatment or have primary refractory disease
2. For children who have relapsed, only those in whom this is the first relapse are eligible
3. Provide signed, written informed consent from parent and/or guardian
4. Protocol to have received national local ethical committee approval

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

480

Participant exclusion criteria

1. Children less than 1 year old and young adults of 18 years of age and older
2. Children in whom this is not the first relapse of their disease
3. Children with first relapse who have already received chemotherapy or radiotherapy prior to starting R3
4. Children with mature B cell ALL

Recruitment start date

06/01/2003

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Australia, Ireland, Netherlands, New Zealand, United Kingdom

Trial participating centre

University of Manchester
Manchester
M20 4BX
United Kingdom

Sponsor information

Organisation

Central Manchester University Hospitals NHS Foundation Trust (UK)

Sponsor details

Trust HQ
Corbett House
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Sponsor type

Government

Website

http://www.cmft.nhs.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK (UK) (ref: ONPG1A1R) - Funding for trial manager

Alternative name(s)

CRUK

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

2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/21131038
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25279465

Publication citations

  1. Results

    Parker C, Waters R, Leighton C, Hancock J, Sutton R, Moorman AV, Ancliff P, Morgan M, Masurekar A, Goulden N, Green N, Révész T, Darbyshire P, Love S, Saha V, Effect of mitoxantrone on outcome of children with first relapse of acute lymphoblastic leukaemia (ALL R3): an open-label randomised trial., Lancet, 2010, 376, 9757, 2009-2017, doi: 10.1016/S0140-6736(10)62002-8.

  2. Results

    Masurekar AN, Parker CA, Shanyinde M, Moorman AV, Hancock JP, Sutton R, Ancliff PJ, Morgan M, Goulden NJ, Fraser C, Hoogerbrugge PM, Revesz T, Darbyshire PJ, Krishnan S, Love SB, Saha V, Outcome of central nervous system relapses in childhood acute lymphoblastic leukaemia--prospective open cohort analyses of the ALLR3 trial, PLoS One, 2014 , 9, 10, e108107, doi: 10.1371/journal.pone.0108107.

Additional files

Editorial Notes