|
Welcome
|
|
02 September 2010
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ ...Back to search results ] | [ Print-friendly version ] |
| An International Collaborative Trial for Relapsed and Refractory Acute Lymphoblastic Leukaemia |
| ISRCTN | ISRCTN45724312 |
| ClinicalTrials.gov identifier | NCT00967057 |
| Public title | An International Collaborative Trial for Relapsed and Refractory Acute Lymphoblastic Leukaemia |
| Scientific title | |
| Acronym | ALLR3 |
| Serial number at source | N/A |
| 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 |
| Countries of recruitment | United Kingdom, Ireland, Australia, New Zealand, Netherlands |
| Disease/condition/study domain | Relapsed and Refractory Acute Lymphoblastic Leukaemia (ALL) |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 06/01/2003 |
| Anticipated end date | 31/12/2011 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 480 |
| Interventions |
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 |
| Primary outcome measure(s) |
Added 13/05/10:
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 measure(s) |
Added 13/05/10:
1. MRD as a surrogate marker for PFS 2. Randomised comparison between Mitoxantrone and Idarubicin |
| Sources of funding | Cancer Research UK (UK) (ref: ONPG1A1R) - Funding for trial manager |
| Trial website | |
| Publications | |
| Contact name | Prof Vaskar Saha |
| Address |
Academic Unit of Paediatric & Adolescent Oncology
University of Manchester Wilmslow Road |
| City/town | Manchester |
| Zip/Postcode | M20 4BX |
| Country | United Kingdom |
| Tel | +44 (0)161 446 3023 |
| Fax | +44 (0)161 446 3092 |
| vaskar.saha@manchester.ac.uk | |
| Sponsor | Central Manchester University Hospitals NHS Foundation Trust (UK) |
| Address |
Trust HQ
Corbett House Manchester Royal Infirmary Oxford Road |
| City/town | Manchester |
| Zip/Postcode | M13 9WL |
| Country | United Kingdom |
| Sponsor website: | http://www.cmft.nhs.uk |
| Date applied | 01/10/2003 |
| Last edited | 14/05/2010 |
| Date ISRCTN assigned | 01/10/2003 |
|
|
|
|
|
| © 2010 ISRCTN unless otherwise stated. | |
|
|
|
|