CALLS = CML and ALL Low Level Mutation Study in the UK [UK]
Study title
CALLS Study = CML and ALL Low Level Mutation Study
Scientific title
A Cohort Study To Establish the Prevalence of Mutations in Patients with CML Who Meet the ELN Criteria for Warning or Failure and Patients With Ph+ALL With Detectable BCR-ABL1 Currently Being Treated With First or Subsequent TKI Therapy in the UK Using Next Generation Sequencing. (ClinicalTrials.gov no NCT03647215)
Type of study
Other trials
Current status
No longer recruiting
What is the purpose of the study
This is an observational study to establish the prevalence of mutations in patients with CML who meet the ELN criteria for warning or failure and patients with Ph+ ALL with detectable BCR-ABL currently being treated with first or subsequent TKI therapy in the UK.
Key inclusion criteria
Adult patients (age ≥ 18 years) with CML (in all phases of disease) or Ph+ ALL with detectable BCR-ABL levels who are being treated with a first or subsequent tyrosin kinase inhibitor (TKI).
Patients with CML must meet the warning or failure criteria as per the ELN guidelines for first second and subsequent treatment line, including:
BCR-ABL/ABL IS transcripts > 10% at 3 months
BCR-ABL/ABL IS transcripts > 1% at 6 months
BCR-ABL/ABL IS transcripts > 0.1% at 12 months or later OR
Ph+ve ALL patients with any level of BCR-ABL/ABL IS transcripts who are not eligible for UKALL 14 or are not currently enrolled in UKALL 14
Key exclusion criteria
Where can I find additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study sponsor
Incyte Biosciences UK
Scientific lead / contact
Study Director: Michael Thompson, MD Incyte Biosciences UK
Principal investigator
Hugues de Lavallade
Study centers / principal investigators
Ireland
University Hospital Waterford
Waterford, X91 ER8E
UK
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LQ
Royal Devon & Exeter Hospital
Exeter, Devon, EX2 5DW
Broomfield Hospital Chelmsford
Chelmsford, Essex, CM1 7ET
Derriford Hospital
Plymouth, Devon, PL6 8DH
Queen’s Hospital
Romford, Essex, RM7 0AG
Aberdeen Royal Infirmary
Aberdeen, Foresterhill, AB25 2ZN
Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY
Medway Maritime Hospital
Gillingham, Kent, ME75NY
Blackpool Victoria Hospital
Blackpool, Lancashire, FY3 8NR
Royal Oldham Hospital
Manchester, Lancashire, OL1 2JH
Queens Medical Centre
Nottingham, Nottinghamshire, NG7 2UH
Ipswich Hospital
Ipswich, Suffolk, IP4 5PD
Heart of England NHS Foundation Trust
Birmingham, West Midlands, B9 5SS
Russells Hall Hospital
Dudley, West Midlands, DY1 2HQ
King’s College Hospital
London, SE5 9R
Bradford Royal Infirmary
Bradford, West Yorkshire, BD9 6RJ
St James’s University Hospital
Leeds, West Yorkshire, LS9 7TF
Monklands Hospital
Airdrie, ML6 0JS
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED
Addenbrooke’s Hospital
Cambridge, CB2 0QQ
University Hospital Wales
Cardiff, CF14 4XW
Croydon University Hospital, Croydon Health Services NHS Trust
Croydon, CR7 7YE
Western General Hospital
Edinburgh, EH4 2XU
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Guy’s Hospital
London, SE1 9RT
King’s College Hospital
London, SE5 9RS
The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
Middlesbrough, TS4 3BW
Oxford University Hospitals NHS Foundation Trust
Oxford, OX4 2PG
Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS FT
Sheffield, S10 2JF
Royal Stoke University Hospital, Cancer Centre, University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, ST4 6QG
Singleton Hospital
Swansea, SA2 8QA