Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05341050 |
Other study ID # |
TKIs-cml |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 1, 2022 |
Est. completion date |
May 31, 2026 |
Study information
Verified date |
April 2022 |
Source |
Nanfang Hospital of Southern Medical University |
Contact |
xu na |
Phone |
18620698390 |
Email |
sprenaa[@]163.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
patients with Ph+ CML-CP who have been treated with second-generation TKIs (nilotinib,
dasatinib) for at least 3 years and maintains MMR for at least 2 years, continue to be
treated with halved dose for 12 months, and then stop for 12 months.
Description:
1.Patients with Ph+ CML-CP who have been treated with second-generation TKIs (nilotinib,
dasatinib) for at least 3 years and maintains MMR for at least 2 years.
2。During the TKI reduction phase, the peripheral blood BCR/ABLIS was detected by Q-PCR every
two months and continuously monitored for 12 months. In the TFR period, the peripheral blood
BCR/ABLIS was detected once a month for the first 6 months; the peripheral blood BCR/ABLIS
was detected once every two months for the next 6 months; after that, the peripheral blood
BCR/ABLIS was detected once every three months.
3.If the patients detected molecular recurrence (loss of MMR, BCR/ABL IS>0.1%),the original
dose of 2G-TKI should be administered