An International Collaborative Trial for Relapsed and Refractory Acute Lymphoblastic Leukaemia

ISRCTN	ISRCTN45724312
DOI	https://doi.org/10.1186/ISRCTN45724312
ClinicalTrials.gov (NCT)	NCT00967057
Clinical Trials Information System (CTIS)	2004-000052-16
Protocol serial number	N/A
Sponsor	Central Manchester University Hospitals NHS Foundation Trust (UK)
Funder	Cancer Research UK (UK) (ref: ONPG1A1R) - Funding for trial manager

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	An International Collaborative Trial for Relapsed and Refractory Acute Lymphoblastic Leukaemia
Study acronym	ALLR3
Study objectives	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(s)	Ethics approval received from the Multicentre Research Ethics Committee for Wales (ref: 02/9/21)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Added 13/05/2010: 1. MRD as a surrogate marker for PFS 2. Randomised comparison between Mitoxantrone and Idarubicin
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Year
Upper age limit	18 Years
Sex	All
Target sample size at registration	480
Key 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
Key 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
Date of first enrolment	06/01/2003
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

United Kingdom
England
Australia
Ireland
Netherlands
New Zealand

Study participating centre

University of Manchester

Manchester
M20 4BX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	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.