Multicenter Phase II Clinical Study of the research on optimal assessments and treatment strategy of nilotinib in newly diagnosed chronic myelogenous leukemia patients in the chronic phase (CML-CP) based on early achievement of complete molecular response (CMR); N-road

Multicenter Phase II Clinical Study of the research on optimal assessments and treatment strategy of nilotinib in newly diagnosed chronic myelogenous leukemia patients in the chronic phase (CML-CP) based on early achievement of complete molecular response (CMR); N-road - N-road trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008565

Enrollment

Registered

2012-08-01

Start date

2012-08-01

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

Nilotinib (300 mg) is administered twice daily (600 mg/day) for 24 months.In addition, for patients who meet the criteria for no optimal response in this study, nilotinib 400 mg bid (800 mg/day) is in

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.CML patients whom Ph chromosome was detected by chromosomal analysis (G-band method or FISH method) or BCR-ABL mRNA was detected by RT-PCR method 2.CML patients who were diagnosed within 6 months before the registration to the study 3.Patients who do not suggest the accelerated phase (AP) or blastic phase (BP) CML 4.Age 16 years or older 5.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 6.Written informed consent (from the legal representative if the subject is under 20 years old)

Exclusion criteria

Exclusion criteria: 1.Previously treated by tyrosine kinase inhibitors other than imatinib 2.Previously received imatinib for more than 2 weeks 3.Previous treatment experience with IFN-alpha 4.Received oral anticancer drugs such as hydroxyurea for more than 3 months. 5.Confirmed to have the T315I point mutation of BCR-ABL 6.History of hematopoietic stem cell transplantation 7.Patients with cardiovascular dysfunction 8.Other uncontrolled complications. 9.Pregnant women or those with suspected pregnancy. Nursing women and those who plan to become pregnant during the study period.

Design outcomes

Primary

Measure	Time frame
The CMR rate by 24 months after the initiation of nilotinib treatment	—

Secondary

Measure	Time frame
* Percentage of patients maintaining CMR for more than 1 year during 24-month nilotinib treatment period * Cumulative CMR rate by 12 and 18 months after the initiation of nilotinib treatment * Cumulative MMR or MR4 rate by 12, 18, and 24 months after the initiation of nilotinib treatment * Cumulative MCyR or CCyR rate by 6 and 12 months after the initiation of nilotinib treatment * OS, PFS, EFS and investigation of prognosis predicting factors * Factors that predict achieving CMR * Safety and tolerability of nilotinib (including treatment continuation rate)	—

Measure

Time frame

* Percentage of patients maintaining CMR for more than 1 year during 24-month nilotinib treatment period * Cumulative CMR rate by 12 and 18 months after the initiation of nilotinib treatment * Cumulative MMR or MR4 rate by 12, 18, and 24 months after the initiation of nilotinib treatment * Cumulative MCyR or CCyR rate by 6 and 12 months after the initiation of nilotinib treatment * OS, PFS, EFS and investigation of prognosis predicting factors * Factors that predict achieving CMR * Safety and tolerability of nilotinib (including treatment continuation rate)

—

Countries

Japan

Contacts

Public ContactKaichi NISHIWAKI

Jikei University Kashiwa Hospital Department of Oncology and Haematology

nishiwaki@jikei.ac.jp04-7164-1111

Outcome results

None listed

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