Ropeginterferon for Treatment Free Remission

Sponsor
Dong-Wook Kim
Study ID
NCT07105319
Phase
PHASE4
Status
Completed

Conditions

  • CML (Chronic Myelogenous Leukemia)

Eligibility Criteria

Sex
ALL
Age
19 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ropeginterferon — DRUG
    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

Study Details

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.

Key Dates

Start date
Nov 30, 2021
Status verified
Jul 2025
Primary completion
Jul 30, 2025
Completion
Jul 30, 2025

Study Design

Enrollment
65 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: randomized two-arm prospective study with/without Ropeginterferon in CML patients
    The patients will be randomized to a ratio of 1:1 for each group 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

Primary Outcome Measure

Treatment-Free Remission (TFR) rates by 12 months 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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