NCT07105319

Ropeginterferon for Treatment Free Remission

A Feasibility Study of Ropeginterferon for Treatment Free Remission in CML Patients Who Have a Sustained Deep Molecular Response

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Dong-Wook Kim · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• CML (Chronic Myelogenous Leukemia)

Interventions

Type	Name	Description
DRUG	Ropeginterferon	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

Timeline

• Start date: 2021-11-30
• Primary completion: 2025-07-30
• Completion: 2025-07-30
• First posted: 2025-08-05
• Last updated: 2025-08-22

Locations

1 site across 1 country: South Korea