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De-escalation Strategy of Tyrosine Kinase Inhibitors Before Treatment Discontinuation in Patients With Chronic Myeloid Leukemia
Sponsor: Nanfang Hospital, Southern Medical University
Summary
The goal of this clinical trial is to learn if a 1-year dose-reduction strategy with tyrosine kinase inhibitors (TKIs) - before complete discontinuation - works to improve treatment-free remission in adults with chronic-phase chronic myeloid leukaemia (CML) who have already achieved stable deep molecular response and are eligible to stop therapy. It will also learn about the safety of this gradual reduction approach. The main questions it aims to answer are: Does the dose-reduction strategy lead to a higher 2-year molecular relapse-free survival rate (maintaining major molecular response, BCR-ABL1 ≤0.1%) compared with immediate TKI discontinuation? What medical problems (adverse events) do participants experience during and after dose reduction, and how do they differ from those in the direct-stop group? Researchers will compare the dose-reduction group (reduced daily TKI for 12 months, then 1-year follow-up) with the direct-discontinuation group (immediate stop, 2-year follow-up) to see whether gradual reduction is superior in preserving molecular remission. In addition, they will compare the changes in T-cell subsets between the two groups to explore immune mechanisms that may influence treatment-free remission. Participants will: Be randomly assigned to either dose reduction or immediate discontinuation; Take reduced TKI (or no drug) daily for 1 year, followed by 1-year observation (total 24 months); Visit the clinic every 2 months for the first 6 months, then every 3 months thereafter, for physical exams, blood tests, molecular monitoring (BCR-ABL1 PCR), and ECG; Have T-cell subsets measured by flow cytometry at months 3, 6, 12, and 24; Complete quality-of-life questionnaires (EORTC QLQ-CML24) at baseline and at months 3, 6, 12, and 24; Report all adverse events; if MMR is lost, they must restart full-dose TKI and be monitored monthly until remission is regained;
Official title: De-escalation Strategy of Tyrosine Kinase Inhibitors Before Treatment Discontinuation in Patients With Chronic Myeloid Leukemia: Dose Reduction Versus Discontinuation - a Multicenter, Prospective, Randomized Controlled Study
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
280
Start Date
2026-09-09
Completion Date
2030-12-31
Last Updated
2026-09-24
Healthy Volunteers
No
Interventions
Halve TKIs
Participants receive a reduced dose of their current tyrosine kinase inhibitor (TKI) for 12 months. Doses are halved/reduced per protocol: Flumatinib 400/200 mg QD, Imatinib 200 mg QD, Nilotinib 300 mg QD, Dasatinib 50 mg QD, or Olverembatinib 20 mg QD, based on pre-entry therapy. Followed by 12 months of observation without TKI
Withdrawal TKIs
Participants discontinue all tyrosine kinase inhibitor (TKI) therapy immediately after enrollment. No study drug is administered during the 24-month follow-up period. Regular molecular monitoring (BCR-ABL1 qPCR) is performed according to protocol: every 2 months for the first 6 months, and every 3 months thereafter until month 24. Upon confirmed loss of major molecular response (MMR, BCR-ABL1 \> 0.1%), TKI must be re-initiated at the original pre-enrollment dose.
Locations (1)
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China