Gene Expression Profiles in CML Non-respondersNCT04219111
Gene Expression Profiles in CML Non-responders
An observational study of Gene Expression Profiles in CML Non-responders, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Chronic myeloid leukaemia (CML) is a haematological malignancy primarily driven by the fusion oncogene BCR-ABL1, resulting in a constitutively expressed tyrosine kinase. CML is treated very effectively by the tyrosine kinase inhibitors (TKIs) resulting in almost undetectable levels of disease. Read more about this study
- Who is it for?
- Ages 17 to 85 years
- Conditions the study is for
- Gene Expression Profiles in CML Non-responders
- What is being tested?
- Clariom
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2017to 4 May 2018
- 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 17 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: CML patients with poor response to TKIs as identified through routine clinical testing at SDGS, either with or without a tyrosine kinase domain mutation as tested for by mutational analysis.
Who may be able to join
- CML patients with poor response to TKIs as identified through routine clinical testing at SDGS, either with or without a tyrosine kinase domain mutation as tested for by mutational analysis.
Who cannot join
- Any samples that do not meet the above inclusion criteria, but particularly not CML patients with an optimal response to TKIs.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Research Facility
Sheffield, South Yorkshire, S10 2TH
About this study
Official title: Detecting Expression Profiles Associated With Resistance to Tyrosine Kinase Inhibitors in Chronic Myeloid Leukaemia Patients Without Detectable Tyrosine Kinase Domain Mutations, Using Transcriptomics
Chronic myeloid leukaemia (CML) is a haematological malignancy primarily driven by the fusion oncogene BCR-ABL1, resulting in a constitutively expressed tyrosine kinase. CML is treated very effectively by the tyrosine kinase inhibitors (TKIs) resulting in almost undetectable levels of disease. However, some patients show resistance to first line treatment, requiring second and third generation TKIs. Such resistance is due to the presence of tyrosine kinase domain (TKD) mutations, however TKDs do not appear to be present in all patients who do not respond to treatment.
The aim of this project is to utilise gene expression arrays to identify transcriptomic profiles associated with resistance to TKIs in the absence of a demonstrable TKD mutation. The presence of such profiles may allow for a more targeted approach to treatment, if non-responders can be identified earlier in the disease management pathway. Being able to predict those that will not respond to first line treatment will allow for better stratification of patients.
Read the detailed description
The aim of this project is to use gene expression microarrays to detect expression profiles which may be associated with TKI resistance in order to better stratify CML patients and allow a more targeted approach to therapy. The project may also help elucidate the mechanism of resistance in those without a discernible TKD mutation. Ultimately it is hoped that this would lead to larger studies which could improve the clinical pathway for CML patients without TKD mutations.
Some previous studies have studied the gene expression profile of CML patients demonstrating resistance to TKIs, using Affymetrix arrays. However, none of these appear to have specifically investigated non-responders with and without a TKD mutation.
- Being tested
- Clariom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClariomGenetic
Clariom S Assay
What is being measured
The primary outcome is the main question the study is designed to answer.
Success identification of at least 5 markers of resistance in patients without a TKD mutation and confirmation of their expression levels using qPCR
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start1 Oct 2017 (estimated)
- Primary completion4 May 2018
- Study completion4 May 2018
Why it stopped: STUDY LOOKING AT SAMPLES ONLY, NO PARTICIPANT ENROLMENT REQUIRED
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gene Expression Profiles in CML Non-respondersStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219111
- Sponsor's protocol ID
- SCH-2181
- Status last verified
- Jan 2020
- First submitted
- 3 Jan 2020
- Last updated
- 6 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Expression Profiles Associated With Resistance to Tyrosine Kinase Inhibitors in Chronic Myeloid Leukaemia Patients Without Detectable Tyrosine Kinase Domain Mutations, Using Transcriptomics
- ClinicalTrials.gov ID
- NCT04219111
- Acronym / sponsor ID
- SCH-2181
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: STUDY LOOKING AT SAMPLES ONLY, NO PARTICIPANT ENROLMENT REQUIRED
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 6 Jan 2020 (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.
Chronic myeloid leukaemia (CML) is a haematological malignancy primarily driven by the fusion oncogene BCR-ABL1, resulting in a constitutively expressed tyrosine kinase. CML is treated very effectively by the tyrosine kinase inhibitors (TKIs) resulting in almost undetectable levels of disease. However, some patients show resistance to first line treatment, requiring second and third generation TKIs. Such resistance is due to the presence of tyrosine kinase domain (TKD) mutations, however TKDs do not appear to be present in all patients who do not respond to treatment.
The aim of this project is to utilise gene expression arrays to identify transcriptomic profiles associated with resistance to TKIs in the absence of a demonstrable TKD mutation. The presence of such profiles may allow for a more targeted approach to treatment, if non-responders can be identified earlier in the disease management pathway. Being able to predict those that will not respond to first line treatment will allow for better stratification of patients.
Detailed description
The aim of this project is to use gene expression microarrays to detect expression profiles which may be associated with TKI resistance in order to better stratify CML patients and allow a more targeted approach to therapy. The project may also help elucidate the mechanism of resistance in those without a discernible TKD mutation. Ultimately it is hoped that this would lead to larger studies which could improve the clinical pathway for CML patients without TKD mutations.
Some previous studies have studied the gene expression profile of CML patients demonstrating resistance to TKIs, using Affymetrix arrays. However, none of these appear to have specifically investigated non-responders with and without a TKD mutation.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 17 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CML patients with poor response to TKIs as identified through routine clinical testing at SDGS, either with or without a tyrosine kinase domain mutation as tested for by mutational analysis.
Key inclusion criteria (1 listed)
- CML patients with poor response to TKIs as identified through routine clinical testing at SDGS, either with or without a tyrosine kinase domain mutation as tested for by mutational analysis.
Key exclusion criteria (1 listed)
- Any samples that do not meet the above inclusion criteria, but particularly not CML patients with an optimal response to TKIs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClariomClariom S Assay | Genetic | – |
Primary outcome
Success identification of at least 5 markers of resistance in patients without a TKD mutation and confirmation of their expression levels using qPCR
Time frame: 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gene Expression Profiles in CML Non-responders, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
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 1 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: withdrawn, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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?
Success identification of at least 5 markers of resistance in patients without a TKD mutation and confirmation of their expression levels using qPCR (time frame: 2 months). 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 6 Jan 2020; AzTrials last refreshed its copy on 29 Oct 2026.