Phase 2 study of the treatment discontinuation after the change from 2nd tyrosine kinase inhibitors to Interferon-alpha in chronoic myeloid leukemia patients who maintained molecular remission.
Phase 1
- Conditions
- Chronic myeloid leukemia (CML) in 1st chronic phase and MR4.0 with complete molecular response (CMR) sustained for more than 2 years with 2nd generation tyrosine kinase inhibitors (TKIs).
- Registration Number
- JPRN-UMIN000016064
- Lead Sponsor
- CML Cooperative Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention. 2) Patients with uncontrolled active infection. 3) Patients with suspicion of interstitial pneumonitis. 4) History of depression. 5) Patients with uncontrolled diabetes. 6) Patients who currently receiving systemic treatment with corticoid or immunosuppressive drugs. 7) Patients whose physicians consider not appropriate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Among evaluable patients, the ratio of patients who maintained MMR 12 months after stop of IFN (Molecular relapse-free survival; MoRFS).
- Secondary Outcome Measures
Name Time Method