The prospective, multicenter Stop Tyrosine Kinase Inhibitor trial of pediatric chronic myeloid leukemia with sustained complete molecular response (STKI-14)

The prospective, multicenter Stop Tyrosine Kinase Inhibitor trial of pediatric chronic myeloid leukemia with sustained complete molecular response (STKI-14) - The prospective, multicenter Stop TKI trial of pediatric CML (STKI-14)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017644

Enrollment

Registered

2015-06-01

Start date

2015-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia (CML)

Interventions

After sustained CMR for 2 years or more under the treatment of tyrosine kinase inhibitor (TKI) for 3 years or more, TKI treatment is discontinued. In case of MMR loss, the same TKI as before discontin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with BCR-ABL fusion transcript-positive CML 2) Chronic or accelerated phase at diagnosis 3) Age under 20 years old at diagnosis 4) Regsitered to the JPLSG CHM-14 study 5) The total period of treatment with TKI for 3 years or more 6) CMR maintained for 2 years or more under the treatment of TKI 7) Less than 0.01% of BCR-ABL/ABL mRNA (international scale) within 4 weeks before the registration 9) Sufficient hepatic and renal function satisfying the laboratory data listed below ; a)T-Bili: within 3x of age adjusted upper-limit of normal range. b)Creatinine: within 3x of age adjusted upper-limit of normal range. 10) Written informed consent obtained from patient or guardians

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Treatment-free remission rate at 12 months	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

*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

—

Countries

Japan

Contacts

Public ContactHiroyuki Shimada

Keio University School of Medicine Department of Pediatrics

hshimada@a5.keio.jp03-5363-3816

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026