Chronic myeloid leukemia
Conditions
Interventions
discontinue group:discontinue TKI
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged = 18 years; 2. Patients with Ph chromosome and/or the BCR-ABL (either b3a2 and /or b2a2) fusion gene positive Chronic Myeloid Leukemia in the Chronic Phase; 3. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; 4. Patients are receiving any dose of IM without faliure or resistance, or any dose of second generation TKI (Nilotinib, dasatinib, Nipanatinib or bosutinib); 5. Patient has been on TKI therapy for at least 3 years; 6. Treatments with hydroxyurea, interferon-a (IFN-a) with or withoutcytarabine, priorto TKI were permitted; 7. Patients receiving IM achieve MR4.5 (BCR-ABL1 IS =0.0032%, ABL1 transcripts > 32,000) or deeper response for over 2 years. 2 times of RQ-PCR results per year are necessary; 8. Patients receiving 2nd generation TKI achieve MR4.5 (BCR-ABL1 IS =0.0032%, ABL1 transcripts > 32,000) or deeper response for over 1 years. 2 times of RQ-PCR results per year are necessary; 9. Willing to stop TKI therapy; 10. Female patients of childbearing potential must use an effective barrier contraceptive method; 11. Baseline and prior treatment data of patients areavailable; 12. Understand and voluntarily sign an institutional review board (IRB)-approved informed consent form.
Exclusion criteria
Exclusion criteria: 1. CML in accelerated phase or blast crisis at any time; 2. Previous performed or plannedallo SCT; 3. Patients treated with chemotherapy, radiotherapy or immunosuppressive treatment for other diseases during the past 1 year; 4. Patients who failed the TKI discontinuation for any reason before; 5. Unwilling to stop TKI therapy; 6. Poor compliance with taking TKI; 7. Patients who are unable to comply with lab appointments schedule and assessment procedures; 8. Pregnant or lactating women; 9. Life expectancy less than 36 months; 10. Any serious medical condition including but not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled infection, active/symptomatic heart disease, chronic obstructive pulmonary disease (COPD), renal failure, active hemorrhage, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BCR-ABL; | — |
Countries
China
Contacts
Public ContactJin Jie
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed