FLOR3 Gene Polymorphism in Predicting Outcomes of Tyrosine Kinase Inhibitor（TKI）Stopping in Chronic Myeloid Leukemia (NTU-CML-001)

December 13, 2021 updated by: Affiliated Hospital of Nantong University

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Nantong, China
        • Recruiting
        • Affliated Hospital of Nantong University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  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.

Exclusion Criteria:

NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment-free remission or relapse
Time Frame: 1 year
Observe whether the patients were in remission or relapse 1 year after drug withdrawal
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of Nantong University

Investigators

  • Study Chair: Hong Liu, Doctorate, Affiliated Hospital of Nantong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

November 29, 2021

First Posted (Actual)

December 10, 2021

Study Record Updates

Last Update Posted (Actual)

January 3, 2022

Last Update Submitted That Met QC Criteria

December 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHNTU-CML-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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