Discontinuation study of nilotinib in patients with chronic myeloid leukemia who have maintained complete molecular remission for at least 2 years: the prospective, multicenter stop study in Japan adult leukemia study group

Phase 2

• Conditions: chronic myeloid leukemia

• Registration Number: JPRN-UMIN000024984
• Lead Sponsor: Japan Adult Leukemia Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-24
• Study Completion: 2022-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

1. CML patients in CP, who had an experience of treatment with TKI other than nilotinib or interferon-a for more than 4 weeks 2. CML patients in CP, who have been treated with nilotinib with a daily dose less than 300mg excepting transient dose reduction due to the adverse events 3. CML patients in CP, who had an experience of allogeneic hematopoietic stem cell transplantation 4. CML patients in CP with an episode of disease progression to accelerated or blastic phase 5. CML patients in CP with an episode of loss of CMR despite the continuous treatment with nilotinib 6. CML patients in CP with poor adherence to nilotinib 7.CML patients in CP, who don't accept retreatment with nilotinib after losing TFR 8. CML patients in CP with other inappropriate conditions for the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TFR rate at 12 months after nolotinib discontinuation

Secondary Outcome Measures

Name	Time	Method
1. TFR rate at 24 months after nolotinib discontinuation 2. CMR rate at 12 months and 24 months after nilotinib discontinuation 3. Overall survival, progression-free survival, treatment-free survival, event-free survival 4. Relationship between TFR and CMR duration time, treatment duration time, early molecular response, Sokal risk stratification, and trough concentration 5. Efficacy of the retreatment with nilotinib for CML patients, who lost TFR 6. Analysis of clinical features of nilotinib withdrawal syndrome