chronic myeloid leukaemia
Conditions
Interventions
TKI dose reduction:TKI dose reduction
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years (may be relaxed if general condition is still good). 2. In the chronic phase of CML with no history of accelerated or acute disease. 3. Treatment with an approved TKI, used for > 3 years. 4. Molecular findings in units with stable CF values: maintenance of stable molecular biological response above efficacy (MMR; 1 year. 5. Patients are voluntary patients who voluntarily agree to participate in this trial and sign the informed consent form after fully understanding the nature of the trial, the purpose of the trial, the expected possible benefits and possible risks, and the relevant results of previous studies. 6. For patients who have previously reduced their dose, they can still be enrolled if they meet the conditions, and the total reduction time is 24 months, and they can voluntarily enter the discontinuation phase or continue to maintain the reduced dose after 24 months of reduction.
Exclusion criteria
Exclusion criteria: 1. Patients who have received prior hematopoietic stem cell transplantation or immune cell therapy; 2. Other conditions deemed by the investigator to be inappropriate for participation in clinical observation; 3. Participation in another clinical trial within 4 weeks prior to the start of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maintenance MMR, MR4 rates for 24 months of TKI drug reduction; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS rates at months 6, 12 and 24 after dose reduction;Maintenance MMR and MR4 rates at months 6 and 12 after discontinuation; Median time to loss of MMR, MR4 after TKI drug reduction and discontinuation 24 months of maintenance MMR, MR4 rates;MMR and MR4 rates and median time obtained after resumption of TKI; | — |
Countries
China
Contacts
Public ContactLi Weiming
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Outcome results
None listed