An International Collaborative Trial for Relapsed and Refractory Acute Lymphoblastic Leukaemia

ISRCTN ISRCTN45724312
DOI https://doi.org/10.1186/ISRCTN45724312
EudraCT/CTIS number 2004-000052-16
ClinicalTrials.gov number NCT00967057
Secondary identifying numbers N/A
Submission date
01/10/2003
Registration date
01/10/2003
Last edited
04/03/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-treatment-for-children-and-young-people-with-acute-lymphoblastic-leukaemia

Contact information

Prof Vaskar Saha
Scientific

Academic Unit of Paediatric & Adolescent Oncology
University of Manchester
Wilmslow Road
Manchester
M20 4BX
United Kingdom

Phone +44 (0)161 446 3023
Email vaskar.saha@manchester.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleAn International Collaborative Trial for Relapsed and Refractory Acute Lymphoblastic Leukaemia
Study acronymALLR3
Study objectivesTo 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(s)Ethics approval received from the Multicentre Research Ethics Committee for Wales (ref: 02/9/21)
Health condition(s) or problem(s) studiedRelapsed and Refractory Acute Lymphoblastic Leukaemia (ALL)
InterventionNo 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 typeOther
Primary outcome measureAdded 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 measuresAdded 13/05/2010:
1. MRD as a surrogate marker for PFS
2. Randomised comparison between Mitoxantrone and Idarubicin
Overall study start date06/01/2003
Completion date31/12/2011

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit1 Year
Upper age limit18 Years
SexBoth
Target number of participants480
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment06/01/2003
Date of final enrolment31/12/2011

Locations

Countries of recruitment

  • Australia
  • England
  • Ireland
  • Netherlands
  • New Zealand
  • United Kingdom

Study participating centre

University of Manchester
Manchester
M20 4BX
United Kingdom

Sponsor information

Central Manchester University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

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

Website http://www.cmft.nhs.uk
ROR logo "ROR" https://ror.org/00he80998

Funders

Funder type

Charity

Cancer Research UK (UK) (ref: ONPG1A1R) - Funding for trial manager
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 11/12/2010 Yes No
Results article results 03/10/2014 Yes No
Results article results 01/04/2019 Yes No

Editorial Notes

04/03/2019: Publication reference added.