Efficacy of Nilotinib in Patients with Chronic Myeloid Leukemia in chronic phase unachieved Complete Molecular Response

Efficacy of Nilotinib in Patients with Chronic Myeloid Leukemia in chronic phase unachieved Complete Molecular Response - Efficacy of Nilotinib in Patients with CML unachieved CMR

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006294

Enrollment

Registered

2011-09-06

Start date

2011-05-01

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

Nlotinib treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Chronic myelogenous leukemia in chronic-phase and accerated-phase 2)Patients with CML unachieved CMR who treatment 2y by TKI 3)Age &sup3;20 years 4)PS 0-2(ECOG) 5)No severe major organ dysfunction (AST,ALT, creatinine <3.0x ULN) 6) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients suspected in AP and BC 2) Pregnant and/or lactating woman 3) Severe psychological disorders 4) Uncontorlled complications

Design outcomes

Primary

Measure	Time frame
CMR rate after Nlotinib treatmentat 2-year	—

Secondary

Measure	Time frame
The achievement of CMR time after the administration Nlotinib. CMR rate after Nlotinib treatmentat 1-year. Correlate trough levels of Nlotinib with clinical response.	—

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