CALLS: CML and Ph+ALL Low Level Mutation Prevalence Survey
NCT ID: NCT03647215
Last Updated: 2021-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
427 participants
OBSERVATIONAL
2017-12-18
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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All Participants
Participants with CML and Ph+ALL who are being treated with their first or subsequent TKI therapy. CML patients must meet the ELN criteria for warning and failure ) or have high SOKAL score (\>0.8) or presence of additional chromosomal abnormalities (ACAs) and have detectable BCR-ABL levels. Ph+ALL patients need detectable BCR-ABL levels only.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with CML must not currently be in MMR (ie, have disease with BCR-ABL1/ABL1 transcripts \> 0.1% IS).
OR
* Patients with Ph+ ALL with any level of BCR-ABL/ABL IS transcripts. Patients with Ph+ ALL should have BCR-ABL1/ABL1 transcript levels \> 0.1% and should not be currently enrolled in UKALL14 but may have relapsed during or after participation in UKALL14.
* Patients with an intermediate or high Sokal score (\> 0.8) can be recruited into the study from 3 months after diagnosis, irrespective of BCR-ABL1/ABL1 transcript levels at 3 months.
* Patients with additional chromosomal abnormalities at diagnosis and patients with AP-CML may be recruited into the study, irrespective of BCR-ABL1/ABL1 transcript levels at 3 months and beyond provided BCR-ABL1/ABL1 transcript levels are \> 0.1% IS. It is recommended that these patients have mutational analysis performed every 3 months irrespective of BCR-ABL1/ABL1 transcript levels until they reach MR3/MMR (BCR-ABL1/ABL1 \< 0.1% IS).
* Any patients who have previously undergone testing for KD mutations, irrespective of KD mutational analysis test results.
* Patients who have the ability to understand the requirements of the study and provide written informed consent.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Incyte Biosciences UK
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Thompson, MD
Role: STUDY_DIRECTOR
Incyte Biosciences UK
Locations
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Limerick University Hospital
Limerick, Dooradoyle, Ireland
University Hospital Waterford
Waterford, , Ireland
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom
Royal Devon & Exeter Hospital
Exeter, Devon, United Kingdom
Derriford Hospital
Plymouth, Devon, United Kingdom
Broomfield Hospital Chelmsford
Chelmsford, Essex, United Kingdom
Queen's Hospital
Romford, Essex, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Foresterhill, United Kingdom
Queen Alexandra Hospital
Portsmouth, Hampshire, United Kingdom
Medway Maritime Hospital
Gillingham, Kent, United Kingdom
Blackpool Victoria Hospital
Blackpool, Lancashire, United Kingdom
Royal Oldham Hospital
Manchester, Lancashire, United Kingdom
Queens Medical Centre
Nottingham, Nottinghamshire, United Kingdom
Ipswich Hospital
Ipswich, Suffolk, United Kingdom
Heart of England NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
Russells Hall Hospital
Dudley, West Midlands, United Kingdom
St Bartholomew's Hospital
London, West Smithfield, United Kingdom
Bradford Royal Infirmary
Bradford, West Yorkshire, United Kingdom
St James's University Hospital
Leeds, West Yorkshire, United Kingdom
Monklands Hospital
Airdrie, , United Kingdom
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
University Hospital Wales
Cardiff, , United Kingdom
Croydon University Hospital, Croydon Health Services NHS Trust
Croydon, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Guy's Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
Middlesbrough, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS FT
Sheffield, , United Kingdom
Royal Stoke University Hospital, Cancer Centre, University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, , United Kingdom
Singleton Hospital
Swansea, , United Kingdom
Countries
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Other Identifiers
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INCB 84344-401
Identifier Type: -
Identifier Source: org_study_id
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