Chronic Phase Chronic Myelogenous LeukemiaNCT03647215
CALLS: CML and Ph+ALL Low Level Mutation Prevalence Survey
An observational study of Chronic Phase Chronic Myelogenous Leukemia and Accelerated Phase Chronic Myelogenous Leukemia, run by Incyte Biosciences UK at 33 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Phase Chronic Myelogenous Leukemia, Accelerated Phase Chronic Myelogenous Leukemia, Blastic Phase Chronic Myelogenous Leukemia
- How many people
- 427 participants
- Where
- 33 sitesin 2 countries
- Study dates
- 18 Dec 2017to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 50 centers in the UK, Ireland and France that treat adult patients with CML and Ph+ ALL will be selected for participation in the study. The sites selected will be a mixture of hospital and academic centers. The target study population will include adult patients with CML who meet the ELN criteria for warning or failure or have high SOKAL score > 0.8 or presence of additional chromosomal abnormalities (ACAs), all with detectable BCR-ABL levels. Ph+ ALL patients must have detectable BCR-ABL levels. Patients will be taking their first or subsequent TKI. Consecutive patients within each prescriber's practice who meet the enrollment criteria and provide informed consent will be invited to enroll into the study. Repeat NGS KD mutation testing is permitted under the protocol as deemed part of the standard management of patients.
Who may be able to join
- 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).
Show all 12Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
United Kingdom31 sites
Aberdeen Royal Infirmary
Aberdeen, Foresterhill, AB25 2ZN
Monklands Hospital
Airdrie, ML6 0JS
Heart of England NHS Foundation Trust
Birmingham, West Midlands, B9 5SS
Blackpool Victoria Hospital
Blackpool, Lancashire, FY3 8NR
Bradford Royal Infirmary
Bradford, West Yorkshire, BD9 6RJ
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED
Addenbrooke's Hospital
Cambridge, CB2 0QQ
University Hospital Wales
Cardiff, CF14 4XW
Broomfield Hospital Chelmsford
Chelmsford, Essex, CM1 7ET
Croydon University Hospital, Croydon Health Services NHS Trust
Croydon, CR7 7YE
Russells Hall Hospital
Dudley, West Midlands, DY1 2HQ
Western General Hospital
Edinburgh, EH4 2XU
Royal Devon & Exeter Hospital
Exeter, Devon, EX2 5DW
Medway Maritime Hospital
Gillingham, Kent, ME75NY
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Ipswich Hospital
Ipswich, Suffolk, IP4 5PD
St James's University Hospital
Leeds, West Yorkshire, LS9 7TF
St Bartholomew's Hospital
London, West Smithfield, EC1A 7BE
Guy's Hospital
London, SE1 9RT
King's College Hospital
London, SE5 9RS
Royal Oldham Hospital
Manchester, Lancashire, OL1 2JH
The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
Middlesbrough, TS4 3BW
Queens Medical Centre
Nottingham, Nottinghamshire, NG7 2UH
Oxford University Hospitals NHS Foundation Trust
Oxford, OX4 2PG
Derriford Hospital
Plymouth, Devon, PL6 8DH
Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY
Queen's Hospital
Romford, Essex, RM7 0AG
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
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LQ
Ireland2 sites
Limerick University Hospital
Limerick, Dooradoyle, V94 F858
University Hospital Waterford
Waterford, X91 ER8E
About this study
Official 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-ABL Currently Being Treated With First or Subsequent TKI Therapy in the UK, Ireland, or France Using Next-Generation Sequencing
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.
- Conditions
- Chronic Phase Chronic Myelogenous Leukemia, Accelerated Phase Chronic Myelogenous Leukemia, Blastic Phase Chronic Myelogenous Leukemia, Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
- Keywords
- Chronic myeloid leukemia, chronic phase, accelerated phase, blast phase, Philadelphia chromosome-positive acute lymphoblastic leukemia, tyrosine kinase inhibitor
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase, Leukemia, Myeloid, Accelerated Phase, Blast Crisis, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with any mutation
All samples will be processed by NGS.
Measured: Up to approximately 1 month per individual participant.
Frequency of all specific mutations
All samples will be processed by NGS.
Measured: Up to approximately 1 month per individual participant.
Secondary outcomes (8)
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.
Measured: Up to approximately 1 month per individual participant.
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.
Measured: Up to approximately 1 month per individual participant.
Percentage of participants with individual mutations in Ph+ ALL
All samples will be processed by NGS.
Measured: Up to approximately 1 month per individual participant.
Frequency of individual mutations in Ph+ ALL
All samples will be processed by NGS.
Measured: Up to approximately 1 month per individual participant.
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.
Measured: Up to approximately 1 month per individual participant.
Frequency of individual mutations by whether a patient is intolerant or resistant to their previous TKI
All samples will be processed by NGS.
Measured: Up to approximately 1 month per individual participant.
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.
Measured: Up to approximately 1 month per individual participant.
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.
Measured: Up to approximately 1 month per individual participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start18 Dec 2017
- Primary completion31 Mar 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Phase Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Biosciences UK
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Thompson, MD, Study director, Incyte Biosciences UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647215
- Sponsor's protocol ID
- INCB 84344-401
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2018
- Last updated
- 16 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Blood samples will be identifiable by a code consisting of numbers and initials. Samples may be stored and tested for up to 5 years after the completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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-ABL Currently Being Treated With First or Subsequent TKI Therapy in the UK, Ireland, or France Using Next-Generation Sequencing
- ClinicalTrials.gov ID
- NCT03647215
- Acronym / sponsor ID
- INCB 84344-401
- Conditions
- Chronic Phase Chronic Myelogenous Leukemia, Accelerated Phase Chronic Myelogenous Leukemia, Blastic Phase Chronic Myelogenous Leukemia, Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
- Keywords
- Chronic myeloid leukemia, chronic phase, accelerated phase, blast phase, Philadelphia chromosome-positive acute lymphoblastic leukemia, tyrosine kinase inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- Incyte Biosciences UKIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 50 centers in the UK, Ireland and France that treat adult patients with CML and Ph+ ALL will be selected for participation in the study. The sites selected will be a mixture of hospital and academic centers. The target study population will include adult patients with CML who meet the ELN criteria for warning or failure or have high SOKAL score > 0.8 or presence of additional chromosomal abnormalities (ACAs), all with detectable BCR-ABL levels. Ph+ ALL patients must have detectable BCR-ABL levels. Patients will be taking their first or subsequent TKI. Consecutive patients within each prescriber's practice who meet the enrollment criteria and provide informed consent will be invited to enroll into the study. Repeat NGS KD mutation testing is permitted under the protocol as deemed part of the standard management of patients.
Key inclusion criteria (12 listed)
- 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:
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of participants with any mutation
Time frame: Up to approximately 1 month per individual participant.
All samples will be processed by NGS.
Frequency of all specific mutations
Time frame: Up to approximately 1 month per individual participant.
All samples will be processed by NGS.
8 secondary outcomes
Percentage of participants with individual mutations in chronic phase (CP)-CML, accelerated phase (AP)-CML, and blast phase (BP)-CML
Time frame: Up to approximately 1 month per individual participant.
Frequency of individual mutations in chronic phase (CP)-CML, accelerated phase (AP)-CML, and blast phase (BP)-CML
Time frame: Up to approximately 1 month per individual participant.
Percentage of participants with individual mutations in Ph+ ALL
Time frame: Up to approximately 1 month per individual participant.
Frequency of individual mutations in Ph+ ALL
Time frame: Up to approximately 1 month per individual participant.
Percentage of participants with individual mutations by whether a participant is intolerant or resistant to their previous TKI
Time frame: Up to approximately 1 month per individual participant.
Frequency of individual mutations by whether a patient is intolerant or resistant to their previous TKI
Time frame: Up to approximately 1 month per individual participant.
Percentage of participants with individual mutations by BCR-ABL level
Time frame: Up to approximately 1 month per individual participant.
Frequency of individual mutations by BCR-ABL level
Time frame: Up to approximately 1 month per individual participant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Individual participant dataSharing planned: Undecided. Blood samples will be identifiable by a code consisting of numbers and initials. Samples may be stored and tested for up to 5 years after the completion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Thompson, MD study director
Incyte Biosciences UK
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Phase Chronic Myelogenous Leukemia and Accelerated Phase Chronic Myelogenous Leukemia, run by Incyte Biosciences UK at 33 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with any mutation (time frame: Up to approximately 1 month per individual participant.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.