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A Study of Treatment-free remission Evaluation in Real-world chronic myeloid leukemia-Prospective observational study

A Study of Treatment-free remission Evaluation in Real-world chronic myeloid leukemia-Prospective observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0007901
Enrollment
200
Registered
2022-11-11
Start date
2023-01-18
Completion date
Unknown
Last updated
2022-11-28

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

Conditions

None listed

Interventions

None listed

Sponsors

Gachon University Gil Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Molecular relapse-freesurvival for 12 months after discontinuation of TKI treatment

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactEunju Park

TrinityCRO

daisy.park@trinitycro.com+82-2-535-5353

Outcome results

None listed

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