Evaluation of safety and tolerability of the initial treatment with imatinib for chronic myeloid leukemia in chronic phase (Tokyo STI Study Group)

Evaluation of safety and tolerability of the initial treatment with imatinib for chronic myeloid leukemia in chronic phase (Tokyo STI Study Group) - Evaluation of safety and tolerability of imatinib for CML-CP (TSSG study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000352

Enrollment

100

Registered

2006-03-10

Start date

2002-08-01

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 myelogenous leukemia

Interventions

Orally administer imatinib 400mg/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Philadelphia positive chronic myeloid leukemia in chronic phase. 2) Age over 15 3) Written informed consent to participate the trial

Exclusion criteria

Exclusion criteria: 1) Pregnant and/or lactating woman 2) WBC=3 6) In accelerate or blastic phase 7) Ph positivity <30 % by IFN-a treatment 8) Past history of BMT or PBSCT 9) Receiving investigational agents within 4 weeks 10) Grade 3 heart failure 11) Receiving another anti-leukemic therapy including IFN-a

Design outcomes

Primary

Measure	Time frame
Optimal imatinib dosage based on the grading of adverse event at 6th months	—

Secondary

Measure	Time frame
Hematological/cytogenetical response by imatinib dosage at 6 months	—

Countries

Japan

Contacts

Public ContactYoshinobu Kanda

University of Tokyo Hospital Department of Hematology & Oncology

ycanda-tky@umin.ac.jp

Outcome results

None listed

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