A Study of Treatment-free remission Evaluation in Real-world chronic myeloid leukemia-Prospective observational study
- Conditions
- Neoplasms
- Registration Number
- KCT0007901
- Lead Sponsor
- Gachon University Gil Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 200
1.> 18-year-old male or female patient
2. ECOG execution status 0, 1 or 2
3. Patients diagnosed with BCR/ABL positive chronic-phaseCML by bone marrow examination
4. Patients receiving TKI treatment for at least three years after initial diagnosis, including imatinib, dasatinib, nilotinib, radotinib, etc.
5. For qRT-PCR follow-up observation, patients with BCR/ABL1RQ-PCR < 0.0069IS (MR4.3 or higher) maintained for more than 2 years and had another confirmed response of 0.0069IS or less at the central genetic testing institution that contracted for analysis.
6. Patients who agreed to participate in the study
1. Patients who had previously performed allografts
2. Patients who tried to interrupt TKI before
3. Past history of other active malignancies within 5 years prior to participation in clinical research, excluding fully cured or present basal cell skin cancer and past cervical endothelial cancer
4. Patients who have not recovered from previous surgery
5. Patients treated with other clinical research preparations within one to four weeks prior to the time of registration of the study
6. Pregnant or lactating women
7. Patients who may pose a risk to patient safety when determined by researchers
8. Patients who attempted TKI interruption for reasons other than TFR
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Molecular relapse-freesurvival for 12 months after discontinuation of TKI treatment
- Secondary Outcome Measures
Name Time Method BCR/ABL1 RQ-PCR Method;TKI discontinuation criteria;TKI Interruption Syndrome;overall survival rate;Conduct digitalPCR for BCR/ABL1 to validate the usefulness of TFR prediction