None listed
Conditions
Interventions
Drug : This is a pilot randomized two arm prospective study with/without Ropeginterferon in CML subjects who have sustained MR4.5 for 24-48 months with TKIs.
Subject will be randomized to either
1) S
Sponsors
Uijeongbu Eulji Medical Center, Eulji University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) New CML-CP at diagnosis 2) Patients > age 19 and Patients < age 75 3) BCR-ABL1 transcripts with e13a2 or e14a2 transcripts 4) Sustained MR4.5 for more than 24 months 5) Signed written informed consent
Exclusion criteria
Exclusion criteria: 1) Any contraindication to any of the interferon 2) Documented autoimmune disease at screening or in the medical history 3) Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis at screening 4) Systemic infections, e.g. hepatitis B, hepatitis C, or HIV at screening 5) Any investigational drug less than 6 weeks prior to the first dose of study drug or not recovered from effects of prior administration of any investigational agent 6) History or presence of depression requiring treatment with antidepressant 7) Any risk of suicide at screening or previous suicide attempts 8) Any significant morbidity or abnormality which may interfere with the study participation 9) Pregnancy and breast-feeding females of reproductive potential and males not using effective means of contraception 10) History of active substance or alcohol abuse within the last year 11) Evidence of severe retinopathy (e.g. cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension) 12) Thyroid dysfunction not adequately controlled 13) History of major organ transplantation 14) History of uncontrolled severe seizure disorder 15) Leukocytopenia at the time of screening (< 4.0 x 109/L) 16) Thrombocytopenia at the time of screening (< 100 x 109/L) 17) History of other malignant disease except CML, including solid tumours and hematological malignancies (except basal cell and squamous cell carcinomas of the skin and carcinoma in situ of the cervix that have been completely excised and are considered cured) within the last 3 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BCR-ABL1 quantitation by qRT-PCR | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) TFR duration 2) adverse events including by 12 months after TKI discontinuation, and 3) Quality of Life (QoL) measurement. | — |
Countries
Korea, Republic of
Contacts
Public ContactDong-Wook Kim
Uijeongbu Eulji Medical Center, Eulji University
Outcome results
None listed