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ISRCTN
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ISRCTN45724312
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ClinicalTrials.gov identifier
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Public title
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An International Collaborative Trial for Relapsed and Refractory Acute Lymphobalstic Leukaemia
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Scientific title
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Acronym
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UKALLR3
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Serial number at source
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N/A
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Study hypothesis
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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).
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Ethics approval
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Ethics approval received from the Multicentre Research Ethics Commitee (ref: 02/9/21)
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Relapsed and Refractory Acute Lymphoblastic Leukaemia (ALL)
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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06/01/2003
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Anticipated end date
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01/01/2010
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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480
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Interventions
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No additional procedures are required in the trial. The trial drugs have already been used in previous paediatric oncology trials for many years.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cancer Research UK (UK) (ref: ONPG1A1R) - Funding for trial manager
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Trial website
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Publications
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Contact name
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Prof
Vaskar
Saha
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Address
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Dept of Paediatric Oncology and Haematology
1st Floor Eva Luckes House
Royal London Hospital
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City/town
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London
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Zip/Postcode
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E1 1BB
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Country
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United Kingdom
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Tel
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+44 (0)20 7377 7758
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Fax
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+44 (0)20 7377 7796
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Email
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vaskar.saha@cancer.org.uk
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Sponsor
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Barts and the London NHS Trust (UK)
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Address
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Research and Development Department
3rd Floor Rutland House
42-46 New Road
Whitechapel
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City/town
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London
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Zip/Postcode
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E1 2AX
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Country
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United Kingdom
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Sponsor website:
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http://www.bartsandthelondon.org.uk/
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Date applied
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01/10/2003
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Last edited
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14/11/2007
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Date ISRCTN assigned
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01/10/2003
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