A phase 2 multicenter clinical study evaluating the safety and efficacy of Nilotinib in patients with Imatinib- resistant/intolerant CML in chronic phase

A phase 2 multicenter clinical study evaluating the safety and efficacy of Nilotinib in patients with Imatinib- resistant/intolerant CML in chronic phase - Multicenter clinical study of Nilotinib in CML patients with Imatinib resistance or intolerance(TSSG nilotinib-study)

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001927

Enrollment

Registered

2009-05-01

Start date

2009-04-01

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 will be administered twice daily at a dose of 400 mg (800 mg/day) for 1 year.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with cytogenetically confirmed newly diagnosed Ph+CML-CP. 2) Patients who have not experienced a blast phase or accelerated phase of CML before treatment with Nilotinib. 3) CML-CP patients who have been treated with Imatinib for 3 months or longer and diagnosed with Imatinib resistance or intolerance. 4) ECOG performance status of 0-2. 5) Adequate end organ function. 6) Written informed concent prior to any study procedures being performed.

Exclusion criteria

Exclusion criteria: 1) Patients who have received treatment with tyrosine kinase inhibitors(except for imatinib) prior to study entry. 2) Patients who are receiving treatment with other investigational agents. 3) Patients who exhibit the T315I BCR-ABL mutation. 4) Patients who have any cardiac disturbances. 5) Severe medical conditions. 6) Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug. 7) Patients who are: (a)pregnant, (b)breast feeding, (c)male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial.

Design outcomes

Primary

Measure	Time frame
To evaluate the rate of patients with a dose of 800 mg/day at 12 months after starting nilotinib therapy.	—

Secondary

Measure	Time frame
1) To evaluate the response rates at 6 and 12 months of nilotinib therapy. 2) To evaluate the response rates in imatinib-intolerant patients switched to nilotinib therapy at 6 and 12 months after starting imatinib therapy. 3) To evaluate the percentage of patients complying with the protocol treatment by the optimal dose levels at 6 and 12 months of nilotinib therapy. 4) To evaluate the safety of nilotinib 5) To assess the progression-free survival (PFS), the event-free survival (EFS), and the overall survival (OS) at 2 years.	—

Measure

Time frame

1) To evaluate the response rates at 6 and 12 months of nilotinib therapy. 2) To evaluate the response rates in imatinib-intolerant patients switched to nilotinib therapy at 6 and 12 months after starting imatinib therapy. 3) To evaluate the percentage of patients complying with the protocol treatment by the optimal dose levels at 6 and 12 months of nilotinib therapy. 4) To evaluate the safety of nilotinib 5) To assess the progression-free survival (PFS), the event-free survival (EFS), and the overall survival (OS) at 2 years.

—

Countries

Japan

Contacts

Public ContactMasahiro Kizaki

Saitama Medical Center, Saitama Medical University Division of Hematology, Department of Internal Medicine

makizaki@saitama-med.ac.jp

Outcome results

None listed

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