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Clinical observation of voluntary withdrawal of TKIs on CML patients after deep remission

The study of stopping TKIs in Chinese CML patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800014938
Enrollment
Unknown
Registered
2018-02-23
Start date
2018-03-25
Completion date
Unknown
Last updated
2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic myloid lekemia

Interventions

Case series:no

Sponsors

Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) aged =18 years old; (2) chronic phase of CML, no prior history of accelerated or blast crisis; (3) the use of approved TKI treatment, first generation TKIs used for more than 5 years; second-generation TKIs used for more than 3 years; if first generation transformed to second-generation TKIs, taking second-generation drugs for at least 1 year; (4) molecular test results in Tongji or uion hospital: stable molecular response (MR4; = 0.01% IS) for more than 2 years for those patients who taking first generation TKIs, performed at least three months apart; Sustained MR4.0 log for more than 1 year for those patients who taking second-generation TKIs. (or domestic stable CF value of the participating units); (5) patients agree to participate in this trial and have signed an informed consent form.

Exclusion criteria

Exclusion criteria: (1) patients with suspicious blast phase; (2) patients who have previously received hematopoietic stem cell transplantation or immune cell therapy; (3) patients with severe liver and kidney dysfunction (ALT>3 UTR, AST> 3UTR, eGFR <50); (4) despite of achieving MR4.0, the routine blood was abnormal in more than two lines; (5) patients with heart disease and other tumors; (6) other researchers believe that is not suitable for clinical observation of the situation; (7) had participated in other clinical trials within 4 weeks before the start of the study.

Design outcomes

Primary

MeasureTime frame
BCR-ABL1 gene;

Countries

China

Contacts

Public ContactZhu Xiaojian

Tongji Medical College, Huazhong University of Science and Technology

zhuxiojian@hust.edu.cn+86 15071171192

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026