CALLS: CML and Ph+ALL Low Level Mutation Prevalence Survey
- Conditions
- Accelerated Phase Chronic Myelogenous LeukemiaBlastic Phase Chronic Myelogenous LeukemiaPhiladelphia Chromosome-positive Acute Lymphoblastic LeukemiaChronic Phase Chronic Myelogenous Leukemia
- Registration Number
- NCT03647215
- Lead Sponsor
- Incyte Biosciences UK
- Brief Summary
A multicenter, prospective cohort study of the mutation status of patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who are being treated with first or subsequent tyrosine kinase inhibitor (TKI) therapy in the UK, Ireland, or France.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 427
-
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 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
-
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.
Patients without detectable BCR-ABL and patients who have switched TKI due to intolerance but who have met the criteria for optimal response (CP-CML, ELN 2013 guidelines).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants with any mutation Up to approximately 1 month per individual participant. All samples will be processed by NGS.
Frequency of all specific mutations Up to approximately 1 month per individual participant. All samples will be processed by NGS.
- Secondary Outcome Measures
Name Time Method Frequency of individual mutations in Ph+ ALL Up to approximately 1 month per individual participant. All samples will be processed by NGS.
Percentage of participants with individual mutations by whether a participant is intolerant or resistant to their previous TKI Up to approximately 1 month per individual participant. All samples will be processed by NGS.
Percentage of participants with individual mutations by BCR-ABL level Up to approximately 1 month per individual participant. All samples will be processed by NGS. BCR-ABL levels defined as \> 0.1% to 1% international scale (IS), \> 1% to 10% IS, \> 10% IS.
Percentage of participants with individual mutations in Ph+ ALL Up to approximately 1 month per individual participant. All samples will be processed by NGS.
Frequency of individual mutations by whether a patient is intolerant or resistant to their previous TKI Up to approximately 1 month per individual participant. All samples will be processed by NGS.
Percentage of participants with individual mutations in chronic phase (CP)-CML, accelerated phase (AP)-CML, and blast phase (BP)-CML Up to approximately 1 month per individual participant. Participants in all phases of CML (CP, AP, and BP) will be enrolled.
Frequency of individual mutations in chronic phase (CP)-CML, accelerated phase (AP)-CML, and blast phase (BP)-CML Up to approximately 1 month per individual participant. Participants in all phases of CML (CP, AP, and BP) will be enrolled.
Frequency of individual mutations by BCR-ABL level Up to approximately 1 month per individual participant. All samples will be processed by NGS. BCR-ABL levels defined as \> 0.1% to 1% international scale (IS), \> 1% to 10% IS, \> 10% IS.
Trial Locations
- Locations (33)
Blackpool Victoria Hospital
🇬🇧Blackpool, Lancashire, United Kingdom
Limerick University Hospital
🇮🇪Limerick, Dooradoyle, Ireland
Queen Alexandra Hospital
🇬🇧Portsmouth, Hampshire, United Kingdom
Royal Oldham Hospital
🇬🇧Manchester, Lancashire, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, United Kingdom
Broomfield Hospital Chelmsford
🇬🇧Chelmsford, Essex, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Foresterhill, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, Cornwall, United Kingdom
Western General Hospital
🇬🇧Edinburgh, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom
Russells Hall Hospital
🇬🇧Dudley, West Midlands, United Kingdom
Derriford Hospital
🇬🇧Plymouth, Devon, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Heart of England NHS Foundation Trust
🇬🇧Birmingham, West Midlands, United Kingdom
St James's University Hospital
🇬🇧Leeds, West Yorkshire, United Kingdom
University Hospital Wales
🇬🇧Cardiff, United Kingdom
Royal Stoke University Hospital, Cancer Centre, University Hospitals of North Midlands NHS Trust
🇬🇧Stoke-on-Trent, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, West Yorkshire, United Kingdom
Monklands Hospital
🇬🇧Airdrie, United Kingdom
Croydon University Hospital, Croydon Health Services NHS Trust
🇬🇧Croydon, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
Medway Maritime Hospital
🇬🇧Gillingham, Kent, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, Suffolk, United Kingdom
Queen's Hospital
🇬🇧Romford, Essex, United Kingdom
University Hospital Waterford
🇮🇪Waterford, Ireland
Royal Devon & Exeter Hospital
🇬🇧Exeter, Devon, United Kingdom
Queens Medical Centre
🇬🇧Nottingham, Nottinghamshire, United Kingdom
St Bartholomew's Hospital
🇬🇧London, West Smithfield, United Kingdom
Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS FT
🇬🇧Sheffield, United Kingdom
Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, United Kingdom
The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
🇬🇧Middlesbrough, United Kingdom
Singleton Hospital
🇬🇧Swansea, United Kingdom
Guy's Hospital
🇬🇧London, United Kingdom