FolateNTU-CML-001NCT05152537
FLOR3 Gene Polymorphism in Predicting Outcomes of Tyrosine Kinase Inhibitor（TKI）Stopping in Chronic Myeloid Leukemia
An observational study of Folate and CML, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
For patients with chronic myeloid leukemia in chronic phase (CML-CP) who have achieved a stable deep molecular response (DMR) using BCR-ABL1 tyrosine kinase inhibitors (TKIs), treatment-free remission (TFR) following TKI cessation is an emerging goal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Folate, CML, Treatment-free Remission
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to Dec 2023
- 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
- Adult, Older adult
Study population: 1. The patient signs the informed consent form 2. Age over 18, male or female 3. The patient was diagnosed as chronic phase of CML. 4. ECoG score 0-2 5. Receive TKI treatment for at least 4 years and continuously obtain MR4 or mr4.5 for at least 3 years. 6. The subjects fully understand and comply with the requirements of the research scheme and are willing to complete the research as planned.
Who may be able to join
- The patient signs the informed consent form
- Age over 18, male or female
- The patient was diagnosed as chronic phase of CML.
- ECoG score 0-2
- Receive TKI treatment for at least 4 years and continuously obtain MR4 or mr4.5 for at least 3 years.
- The subjects fully understand and comply with the requirements of the research scheme and are willing to complete the research as planned.
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affliated Hospital of Nantong University
Nantong
Hong N Liu, Doctorate, +8613951300660, hongliu63@126.com
Lu Zhou, Doctorate, 18761720268, xueyezhoulu2007@sina.com
About this study
Official title: A Multicenter Prospective Cohort Study of FLOR3 Gene Polymorphism in Predicting Outcomes of TKI-stopping in Chronic Myeloid Leukemia
For patients with chronic myeloid leukemia in chronic phase (CML-CP) who have achieved a stable deep molecular response (DMR) using BCR-ABL1 tyrosine kinase inhibitors (TKIs), treatment-free remission (TFR) following TKI cessation is an emerging goal. However, about half of the patients relapsed after TKI discontinuation. There is no definite examinations to predict the outcome of TKI discontinuation. Investigators aim to study the relationship between FLOR3 SNP rs139130389 and the outcome of TKI discontinuation.
Read the detailed description
Investigators aim to detect FOLR3 SNP rs139130389, and establish its correlation with patients' treatment response, remission time, TKI resistance and the outcome of TKI stopping.
- Conditions
- Folate, CML, Treatment-free Remission
- Keywords
- FOLR3, CML, TFR
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment-free remission or relapse
Observe whether the patients were in remission or relapse 1 year after drug withdrawal
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start1 Jan 2021
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FolateStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Liu, Doctorate, Study chair, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152537
- Sponsor's protocol ID
- AHNTU-CML-001
- Acronym
- NTU-CML-001
- Status last verified
- Aug 2021
- First submitted
- 29 Nov 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Cohort Study of FLOR3 Gene Polymorphism in Predicting Outcomes of TKI-stopping in Chronic Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05152537
- Acronym / sponsor ID
- NTU-CML-001 / AHNTU-CML-001
- Conditions
- Folate, CML, Treatment-free Remission
- Keywords
- FOLR3, CML, TFR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 10 Dec 2021 (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.
For patients with chronic myeloid leukemia in chronic phase (CML-CP) who have achieved a stable deep molecular response (DMR) using BCR-ABL1 tyrosine kinase inhibitors (TKIs), treatment-free remission (TFR) following TKI cessation is an emerging goal. However, about half of the patients relapsed after TKI discontinuation. There is no definite examinations to predict the outcome of TKI discontinuation. Investigators aim to study the relationship between FLOR3 SNP rs139130389 and the outcome of TKI discontinuation.
Detailed description
Investigators aim to detect FOLR3 SNP rs139130389, and establish its correlation with patients' treatment response, remission time, TKI resistance and the outcome of TKI stopping.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 1. The patient signs the informed consent form 2. Age over 18, male or female 3. The patient was diagnosed as chronic phase of CML. 4. ECoG score 0-2 5. Receive TKI treatment for at least 4 years and continuously obtain MR4 or mr4.5 for at least 3 years. 6. The subjects fully understand and comply with the requirements of the research scheme and are willing to complete the research as planned.
Key inclusion criteria (6 listed)
- The patient signs the informed consent form
- Age over 18, male or female
- The patient was diagnosed as chronic phase of CML.
- ECoG score 0-2
- Receive TKI treatment for at least 4 years and continuously obtain MR4 or mr4.5 for at least 3 years.
Key exclusion criteria (1 listed)
- NA
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
treatment-free remission or relapse
Time frame: 1 year
Observe whether the patients were in remission or relapse 1 year after drug withdrawal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Hong Liu, Doctorate study chair
Affiliated Hospital of Nantong University
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 Folate and CML, run by Affiliated Hospital of Nantong University at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 3 Jan 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Liu, Doctorate (+8613951300660, hongliu63@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment-free remission or relapse (time frame: 1 year). 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 3 Jan 2022.