Status:
UNKNOWN
TKI Discontinuation in CML Patients of China
Lead Sponsor:
Shenzhen Second People's Hospital
Conditions:
Leukemia
Myelogenous
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this study is to describe the maintenance of the molecular remission after tyrosine kinase inhibitor (TKI) disconnection in chronic myeloid leukaemia (CML) patients in China i...
Detailed Description
Tyrosine kinase inhibitors (TKIs) are the standard of care for patients with chronic myeloid leukaemia (CML) in chronic phase. Imatinib, the first ATP competitive TKI, received approval for use based ...
Eligibility Criteria
Inclusion
- Adults with CML-CP/AP and willingness of TKI discontinuation;
- With ≥ 5 years frontline imatinib, reached MMR (major molecular response) in 2 years, with ≥ 2 years MR (molecular response) 4.5;
- Reached MMR with frontline imatinib, with ≥ 2 years nilotinib, with ≥ 1 year MR4.5;
- Failure with frontline imatinib, reached MMR in 1 year with nilotinib, with ≥ 2 years MR4.5;
- With ≥ 3 years frontline imatinib, reached MMR in 1 year, with ≥ 2 years MR4.5.
Exclusion
- Diagnosed with CML-BP before TKI treatment;
- With a TKI discontinuation of over 30 days in the first year;
- With a TKI discontinuation of over 30days on average annually;
- Reduced the dosage of TKI treatment without instructions;
- Transferred to the second-generation TKIs after resistance to imatinib.
- Under the treatment of stem cells transplantation
Key Trial Info
Start Date :
March 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 30 2022
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT03251352
Start Date
March 1 2017
End Date
October 30 2022
Last Update
March 16 2022
Active Locations (1)
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1
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China, 518035