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

NCT05152537 | Unknown DMC

• 1 other identifier: AHNTU-CML-001
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Folate; CML; Treatment-free Remission

Keywords

FOLR3; CML; TFR

Outcome Measures

Primary Outcomes (1)

• treatment-free remission or relapse

  Observe whether the patients were in remission or relapse 1 year after drug withdrawal

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affliated Hospital of Nantong University

Nantong, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

5ml Peripheral blood of CML patients who discontinued TKI treatment are extracted and stored.

Study Officials

• Hong Liu, Doctorate

  Affiliated Hospital of Nantong University

  STUDY CHAIR

Central Study Contacts

Hong Liu, Doctorate

CONTACT

+8613951300660; hongliu63@126.com

Lu Zhou, Doctorate

CONTACT

18761720268; xueyezhoulu2007@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 10, 2021
• Study Start: January 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 3, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)