Multi-Institutional Collaborative Study for Estimating the Persistence of Treatment Free Remission in Chronic Myeloid Leukemia after Stopping Tyrosine Kinase Inhibitor in Japan

J-SKI - J-SKI

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000037535

Enrollment

1200

Registered

2019-09-01

Start date

2019-09-01

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

CML (chronic myeloid leukemia)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: CML with major BCR-ABL 1)All patients with CML who will stop TKI because of any reason in general practice or have stopped TKI in clinical trials or in general practice regardless of thee results of TFR. 3) Written informed consent on documents fro the subject or a legal guardian if a patient is a minor

Exclusion criteria

Exclusion criteria: 1) Patients who can not provide clinical information and data before and after stopping TKI or after re-treatment by TKI 2) Other, patients whom the investigator considers to be unsuitable for participation in the study.

Design outcomes

Primary

Measure	Time frame
TFR rate at 5-years after stopping TKI	—

Secondary

Measure	Time frame
TFR rate at 10-years after stopping TKI Estimated Treatment Free Survival (TFS) or Progression Free Survival (PFS) to AP or BC after stopping TKI Cumulative Re-MMR rate after retreatment with TKI in patients who lost TFR	—

Countries

Japan

Contacts

Public ContactNaoto Takahashi

Akita University School of Medicine Department of Hematology, Nephrology, and Rheumatology

naotot@doc.med.akita-u.ac.jp018-834-1111

Outcome results