Ropeginterferon is a long-acting next-generation mono-pegylated interferon alfa-2b consisting of one isoform produced by PharmaEssentia Co. and the pegylated (PEG) formulations that require less frequent administration and have improved efficacy and tolerability. In this study, patients in the investigational arm will receive Ropeginterferon subcutaneously with 250 μg at week 0, 350 μg at week 2, 500 μg at week 4, and thereafter 500 μg bi-weekly until week 24.
This is a pilot, randomized, two-arm, prospective study with or without Ropeginterferon in CML patients who have sustained MR4.5 for 24 months or more with TKIs. The patients will be randomized to either 1. Investigational arm with Ropeginterferon (50 patients): Patients will be treated with 250 μg at week 0, 350 μg at week 2, and then 500μg at week 4, and thereafter bi-weekly subcutaneous injection until week 24 2. Comparator arm (50 patients): Patients will be followed with no further CML treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
65
1. Investigational arm with Ropeginterferon (50 patients): Patients will be treated with 250 μg at week 0, 350 μg at week 2, and then 500 μg at week 4, and thereafter bi-weekly subcutaneous injection until week 24 2. Comparator arm (50 patients): Patients will be followed with no further CML treatment
Eulji University Hospital
Uijeongbu-si, Gyeonggi-do, South Korea
Treatment-Free Remission (TFR) rates by 12 months after TKI discontinuation
To assess the preventive efficacy of Ropeginterferon in Major Molecular Response (MMR) loss after TKI discontinuation
Time frame: the screening and week 4/8/12/16/20/24/32/40/48/60/ 72 then after every 12 weeks.
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