NCT04143087

Withdrawal or Reduction TKIs in CML-CP

A Multicenter, Open-access Study of CML-CP Patients Treated With Effective TKIs at Least 5 Years and MR4.5(BCR/ABLIS<0.0032%) Maintenance More Than 18 Months Who Treatment With Half TKIs or Discontinue

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• MMR on 12 Month

Interventions

Type	Name	Description
DRUG	withdrawal TKIs or halve TKIs	Stop TKIs or treated by half TKIs

Timeline

• Start date: 2019-10-23
• Primary completion: 2021-10-31
• Completion: 2021-12-31
• First posted: 2019-10-29
• Last updated: 2021-09-05

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study