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nilotinib pharmacokinetics correlation with clinical response and adverse events in chronic myelogenous leukemia

nilotinib pharmacokinetics correlation with clinical response and adverse events in chronic myelogenous leukemia - nilotinib pahrmacokinetics in Japanese CML patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000002895
Enrollment
30
Registered
2009-12-14
Start date
2009-09-01
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

chronic myelogenous leukemia

Interventions

None listed

Sponsors

Hyogo College of Medicine/Division of Hematology, Department of Internal Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Chronic myelogenous leukemia in chronic-phase and accerated-phase. 2.Age =>20 year 3.PS 0-2(ECOG) 4.No severe major organ dysfunction (AST,ALT, creatinine <3.0x ULN) 5.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Patients suspected in blast crisis 2.History of a invasive double cancer within 5 years before 3.Pregnant and/or lactating woman 4.Severe psychological disorders 5.Uncontorlled complications

Design outcomes

Primary

MeasureTime frame
nilotinib pahrmacokinetics in Japanese CML patients

Secondary

MeasureTime frame
clinical response adverse events

Countries

Japan

Contacts

Public ContactMasaya Okada

hyogo college of medicine Division of Hematology, Department of Internal Medicine

masaya@hyo-med.ac.jp0798-45-6886

Outcome results

None listed

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