A multicenter phase IV clinical trial to examine the change of low-grade side effects after switch to Nilotinib from other tyrosine kinase inhibitors.

A multicenter phase IV clinical trial to examine the change of low-grade side effects after switch to Nilotinib from other tyrosine kinase inhibitors. - A multicenter phase IV clinical trial to examine the change of low-grade side effects after switch to Nilotinib from other tyrosine kinase inhibitors.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000008995

Enrollment

Registered

2012-09-27

Start date

2012-05-01

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

CML chronic phase

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Ph positive CML patients 2) In CP phase at the entry point 3) Received TKI for more than 1 year in total 4) aged 20 or above 5) ECOG Performance Status 0~2 6) Without major organ (liver, kidney, lung) dysfunctions 7) Fulfills the following labo data. 1. T.Bil <= 3 X ULN 2. AST / ALT <= 5 X ULN 3. s-Cr <= 3 X ULN 4. neutrophil counts>=1,000/mm3 5. platelet counts>=50,000/mm3 6. ECG QTc < 480msec 8) Be able to visit the particiating hospital at the scheduled points. 9) With written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients who receive other therapy than TKI for CML 2) Patients participatinng in other clinical trials 3) Patients with bcr-ablT315I mutation 4) Patients who underwent stem cell transplantation 5) Patients with severe or uncontrolled coexisting illness 6) Patients with active malignancies 7) Patients with acute or chronic diseases in liver, pancreas, or severe kidney dysfunction, which is not atttributable to CML 8) Patients in pregnancy, lactation, or not be consent to control births 9) Patients who are assumed ineligible by the primary investigators or corresponding doctors.

Design outcomes

Primary

Measure	Time frame
The change of the side effects that had been observed before, at 3 months after we switch to Nilotinib from Imatinib or Dasatinib.	—

Secondary

Measure	Time frame
All safety profiles. The duration from switch to Nilotinib to amelioration of the side effects. The anti-cancer effects after switch to Nilotinib.	—

Countries

Japan

Contacts

Public ContactYasuhito Nannya

Tokyo CML Conference Office for low grade side effect trial

03-3815-5411(35609)

Outcome results