chronic myeloid leukemia
Conditions
Interventions
Discontinuation of nilotinib and retreatment with nilotinib for CML patients who lost TFR
Sponsors
Japan Adult Leukemia Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. BCR-ABL-positive CML patients in chronic phase (CP) 2. CML patients in CP with ECOG Performance Status 0-2 3. CML patients in CP, who have been treated with nilotinib with a daily dose equal or more than 300mg for more than three years since diagnosis 4. CML patients in CP, who have maintained complete molecular response (CMR) for more than two years 5. CML patients in CP without severe (more than grade 3) adverse events by nilotinib 6. CML patients in CP, who agree to discontinuation of nilotinib 7. CML patients in CP, who can visit the hospital on scheduled days 8. CML patients in CP with written consent for the trial
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TFR rate at 12 months after nolotinib discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactItaru Matsumura
Kinki University, Faculty of Medicine Department of Hematology and Rheumatology
Outcome results
None listed