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

UMIN ID: C000000352

Registered date:10/03/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic myelogenous leukemia
• Date of first enrollment: 2002/08/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Orally administer imatinib 400mg/day

Outcome(s)

• Primary Outcome: Optimal imatinib dosage based on the grading of adverse event at 6th months
• Secondary Outcome: Hematological/cytogenetical response by imatinib dosage at 6 months

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Pregnant and/or lactating woman 2) WBC<3000/mm3 3) serum bilirubin or creatinine level above twice as the upper limit of normal 4) GPT or GOT level above 3 times as the upper limit of normal 5) PS >=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

Related Information

• Primary Sponsor: Tokyo STI Study Group
• Source(s) of Monetary Support: None