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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03647215
Other study ID # INCB 84344-401
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 18, 2017
Est. completion date June 30, 2021

Study information

Verified date August 2021
Source Incyte Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 427
Est. completion date June 30, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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. Exclusion Criteria: 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


Related Conditions & MeSH terms


Locations

Country Name City State
Ireland Limerick University Hospital Limerick Dooradoyle
Ireland University Hospital Waterford Waterford
United Kingdom Aberdeen Royal Infirmary Aberdeen Foresterhill
United Kingdom Monklands Hospital Airdrie
United Kingdom Heart of England NHS Foundation Trust Birmingham West Midlands
United Kingdom Blackpool Victoria Hospital Blackpool Lancashire
United Kingdom Bradford Royal Infirmary Bradford West Yorkshire
United Kingdom Bristol Haematology and Oncology Centre Bristol
United Kingdom Addenbrooke's Hospital Cambridge
United Kingdom University Hospital Wales Cardiff
United Kingdom Broomfield Hospital Chelmsford Chelmsford Essex
United Kingdom Croydon University Hospital, Croydon Health Services NHS Trust Croydon
United Kingdom Russells Hall Hospital Dudley West Midlands
United Kingdom Western General Hospital Edinburgh
United Kingdom Royal Devon & Exeter Hospital Exeter Devon
United Kingdom Medway Maritime Hospital Gillingham Kent
United Kingdom Beatson West of Scotland Cancer Centre Glasgow
United Kingdom Ipswich Hospital Ipswich Suffolk
United Kingdom St James's University Hospital Leeds West Yorkshire
United Kingdom Guy's Hospital London
United Kingdom King's College Hospital London
United Kingdom St Bartholomew's Hospital London West Smithfield
United Kingdom Royal Oldham Hospital Manchester Lancashire
United Kingdom The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust Middlesbrough
United Kingdom Queens Medical Centre Nottingham Nottinghamshire
United Kingdom Oxford University Hospitals NHS Foundation Trust Oxford
United Kingdom Derriford Hospital Plymouth Devon
United Kingdom Queen Alexandra Hospital Portsmouth Hampshire
United Kingdom Queen's Hospital Romford Essex
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 Royal Cornwall Hospital Truro Cornwall

Sponsors (1)

Lead Sponsor Collaborator
Incyte Biosciences UK

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of participants with any mutation All samples will be processed by NGS. Up to approximately 1 month per individual participant.
Primary Frequency of all specific mutations All samples will be processed by NGS. Up to approximately 1 month per individual participant.
Secondary Percentage of participants with individual mutations in chronic phase (CP)-CML, accelerated phase (AP)-CML, and blast phase (BP)-CML Participants in all phases of CML (CP, AP, and BP) will be enrolled. Up to approximately 1 month per individual participant.
Secondary Frequency of individual mutations in chronic phase (CP)-CML, accelerated phase (AP)-CML, and blast phase (BP)-CML Participants in all phases of CML (CP, AP, and BP) will be enrolled. Up to approximately 1 month per individual participant.
Secondary Percentage of participants with individual mutations in Ph+ ALL All samples will be processed by NGS. Up to approximately 1 month per individual participant.
Secondary Frequency of individual mutations in Ph+ ALL All samples will be processed by NGS. Up to approximately 1 month per individual participant.
Secondary Percentage of participants with individual mutations by whether a participant is intolerant or resistant to their previous TKI All samples will be processed by NGS. Up to approximately 1 month per individual participant.
Secondary Frequency of individual mutations by whether a patient is intolerant or resistant to their previous TKI All samples will be processed by NGS. Up to approximately 1 month per individual participant.
Secondary Percentage of participants with individual mutations by BCR-ABL level 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. Up to approximately 1 month per individual participant.
Secondary Frequency of individual mutations by BCR-ABL level 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. Up to approximately 1 month per individual participant.
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