NCT05341050

A Study on the Withdrawal of Second-generation Tyrosine Kinase Inhibitors After Dose Reduction in Patients With CML

This Study is a Multicenter, Single-arm, Prospective Study to Evaluate the Efficacy and Safety of Drug Discontinuation After Dose Reduction in Ph+CML-CP Patients Threated With 2G-TKI.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 260 (estimated)
• Sponsor: xuna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• MMR on 12 Month

Interventions

Type	Name	Description
DRUG	TKI	halve dose of 2G-TKI for 12 months and then withdrawal for 12 months

Timeline

• Start date: 2022-04-01
• Primary completion: 2025-12-31
• Completion: 2026-05-31
• First posted: 2022-04-22
• Last updated: 2022-04-22

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study