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Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicenter Stop Imatinib in Japan adult leukemia study group study

Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicenter Stop Imatinib in Japan adult leukemia study group study - JALSG-STIM213 Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011971
Enrollment
62
Registered
2013-11-01
Start date
2013-11-30
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 Chronic phase

Interventions

Sponsors

Japan Adult Leukemia Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)MajorBCR-ABL positive CML-CP 2)Imatinib treatment more than for 3 years 3)Sustained CMR more than for 2 years 4)Patients who can attend the clinical study site in accordance with the pre-defined schedule. 5) Written informed consent from the subject (from the legal representative if the subject is under 20 years old). Criteria after Screeing test 1) confirmed MR4.5 by IS-PCR

Exclusion criteria

Exclusion criteria: 1)Patients with a history of treatment by the other TKI. 2)Patients with a history of hematopoietic stem cell transplantation. 3)Patients who have had blast crisis or accelerated CML. 4) Patients who have lost CMR during imatinib treatment. 5)Patients who have discontined imatinib treatment because of poor adherence. 6)Patients who do not want to re start imatinib after lost of MMR. 7)Other patients whom the investigator considers to be unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
MMR rate at 12 M after discontinuation of treatment

Countries

Japan

Contacts

Public ContactNaoto Takahashi

Akita Univ. Dept. Hematology

naotot@doc.med.akita-u.ac.jp018-884-6115

Outcome results

None listed

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