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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/21131038
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25279465
Publication citations
-
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.
-
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.