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).
Conditions
Interventions
Administration of IFN is started at a dose of 3 million units 2-3 times per week within 4 weeks after discontinuation of nilotinib or dasatinib treatment. Then, after sustained MMR by IFN for 1 year,
Sponsors
CML Cooperative Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with Philadelphia chromosome-positive or bcr-abl fusion transcript-positive CML 1st chronic phase and in CMR maintained for longer than 2 years under 2nd TKIs. 2) ECOG Performance status 0,1,2 3) Adequate end organ function as defined by: i) ALT and AST < 2.5 X ULN (upper limit of normal) ii) T.Bil < 1.5 X ULN iii) Cr < 1.5 x ULN iv) SpO2 under room air = or > 95% 4) Ability to provide written informed consent prior to any study procedures being performed.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Among evaluable patients, the ratio of patients who maintained MMR 12 months after stop of IFN (Molecular relapse-free survival; MoRFS). | — |
Countries
Japan
Contacts
Public ContactKensuke Usuki
NTT Medical Center Tokyo Department of Hematology
Outcome results
None listed