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
Contact information
Prof Vaskar Saha
Scientific
Scientific
Academic Unit of Paediatric & Adolescent Oncology
University of Manchester
Wilmslow Road
Manchester
M20 4BX
United Kingdom
| Phone | +44 (0)161 446 3023 |
|---|---|
| vaskar.saha@manchester.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 06/01/2003 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- Australia
- England
- Ireland
- Netherlands
- New Zealand
- United Kingdom
Study participating centre
University of Manchester
Manchester
M20 4BX
United Kingdom
M20 4BX
United Kingdom
Sponsor information
Central Manchester University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
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" |
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
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
