The prospective, multicenter Stop Tyrosine Kinase Inhibitor trial of pediatric chronic myeloid leukemia with sustained complete molecular response (STKI-14)
Not Applicable
- Conditions
- Chronic Myeloid Leukemia (CML)
- Registration Number
- JPRN-UMIN000017644
- Lead Sponsor
- Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Not provided
Exclusion Criteria
1) History of blast crisis 2) CNS hemorrage more than grade 3 of CACAE v4.0 3) Uncontrolled infection, including active tuberculosis and positive of HIV antibody. 4) Pregnancy or high possibility of pregnancy and giving suck woman. 5) History of congenital or acquired immunodeficiency. 6) QTfc, corrected by Friderics formula as QTfc = QT/RR*1/3, is more than 0.45 seconds. 7) Any inappropriate status judged by physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment-free remission rate at 12 months
- Secondary Outcome Measures
Name Time Method *Cumulative incidence of MMR loss at 12 months after stopping TKI *Cumulative incidence of CMR loss at 12 months after stopping TKI *Exploration of the TFR-related factors *Cumulative incidence of MMR after restarting TKI *Cumulative incidence of CMR after restarting TKI *Growth rate at TKI discontinuation, during MMR maintenance, and after restarting TKI *QOL at TKI discontinuation, during MMR maintenance, and after restarting TKI *Adverse events at TKI discontinuation, during MMR maintenance, and after restarting TKI