MMR on 12 Month
Conditions
Brief summary
Compare MMR on 12 month treated with half TKIs(including imatinib, dasatinib, and nilotinib) or TKIs withdrawal.
Detailed description
1. Chronic myeloid leukemia-Chronic phase(CML-CP) patients treated with receive effective Tyrosine kinase inhibitor -TKI(including imatinib, dasatinib and nilotinib) for more than 5 years, and patients with BCR/ABLIS continuous negative in the last 18 months were randomly admitted to maintain the original effective TKI by half or stop taking . 2. Q-pcr detected BCR/ABLIS in peripheral blood once every month, once every two months after half a year, and continuously monitored for 12 months. 3. If the patients detected molecular recurrence (loss of MMR, BCR/ABLIS \> 0.1%), the original dose of TKI should be administered again.
Interventions
DRUGwithdrawal TKIs or halve TKIs
Stop TKIs or treated by half TKIs
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-70 years old, gender is not limited; 2. Diagnosed CML chronic phase and effective TKI(including imatinib, dasatinib, and nilotinib) was continued for more than 5 years 3. Q-PCR monitored BCR/ABLIS duration \< 0.0032% in the last 18 months 4. Informed consent of the patient or his legal representative
Exclusion criteria
1. Patients had history of CML-AP or CML-BC 2. CML patients with previous or current ABL kinase mutations 3. CML Patients who have received allogeneic hematopoietic stem cell transplantation 4. CML Patients who have received immunotherapy (except interferon, including car-t and other cellular immunotherapy) 5. Woman who is pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MMR(BCR/ABL IS<0.01) on 12 moth | 12 moth | Half dose TKIs or discontinue TKIs treatment |
Countries
China
Contacts
Primary Contactxu na
Outcome results
None listed