CML (Chronic Myelogenous Leukemia)Phase 4ROPEGNCT07105319
Ropeginterferon for Treatment Free Remission
A Phase 4 study testing Ropeginterferon in people with CML (Chronic Myelogenous Leukemia), run by Dong-Wook Kim at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- CML (Chronic Myelogenous Leukemia)
- What is being tested?
- Ropeginterferon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Nov 2021to 30 Jul 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient must satisfy all the following criteria to be enrolled in the study.
- New CML-CP at diagnosis
- Patients aged 19 or more and 75 or less
- BCR-ABL1 transcripts with e13a2 or e14a2 transcripts
- Sustained MR4.5 for 24 months or more
- Signed written informed consent
Who cannot join
- 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 before 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 (count: < 4.0 x 109/L) 16) Thrombocytopenia at the time of screening (count: < 100 x 109/L) 17) History of other malignant diseases except for CML, including solid tumors and hematological malignancies (except basal cell and squamous cell carcinomas of the skin and carcinoma in situ of the cervix that has been completely excised and is considered cured) within the last 3 years
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Eulji University Hospital
Uijeongbu-si, Gyeonggi-do, 11749
About this study
Official title: A Feasibility Study of Ropeginterferon for Treatment Free Remission in CML Patients Who Have a Sustained Deep Molecular Response
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.
Read the 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
- 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
- Comparator arm (50 patients): Patients will be followed with no further CML treatment.
- Conditions
- CML (Chronic Myelogenous Leukemia)
- Being tested
- Ropeginterferon
- Keywords
- Ropeginterferon, TFR, deep molecular response
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopeginterferonDrug
- 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
- Comparator arm (50 patients): Patients will be followed with no further CML treatment
| Study group | Role | What they receive |
|---|---|---|
| randomized two-arm prospective study with/without Ropeginterferon in CML patients | Experimental | 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 Receives: Drug: Ropeginterferon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: the screening and week 4/8/12/16/20/24/32/40/48/60/ 72 then after every 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start30 Nov 2021
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CML (Chronic Myelogenous Leukemia)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a pilot randomized two-arm prospective study with/without Ropeginterferon in CML patients who have sustained MR4.5 for 24 months or more with TKIs The patients will be randomized to a ratio of 1:1 for each group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-Wook Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dong-Wook Kim, Eulji University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105319
- Sponsor's protocol ID
- UEMC-2021-09-025
- Acronym
- ROPEG
- Status last verified
- Jul 2025
- First submitted
- 18 Apr 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Ropeginterferon for Treatment Free Remission in CML Patients Who Have a Sustained Deep Molecular Response
- ClinicalTrials.gov ID
- NCT07105319
- Acronym / sponsor ID
- ROPEG / UEMC-2021-09-025
- Conditions
- CML (Chronic Myelogenous Leukemia)
- Keywords
- Ropeginterferon, TFR, deep molecular response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Dong-Wook KimUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- Comparator arm (50 patients): Patients will be followed with no further CML treatment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot randomized two-arm prospective study with/without Ropeginterferon in CML patients who have sustained MR4.5 for 24 months or more with TKIs The patients will be randomized to a ratio of 1:1 for each group
| Arm | Type | Receives |
|---|---|---|
| randomized two-arm prospective study with/without Ropeginterferon in CML patients | Experimental | Drug: RopeginterferonThe 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 |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A patient must satisfy all the following criteria to be enrolled in the study.
- New CML-CP at diagnosis
- Patients aged 19 or more and 75 or less
- BCR-ABL1 transcripts with e13a2 or e14a2 transcripts
- Sustained MR4.5 for 24 months or more
Key exclusion criteria (1 listed)
- 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 before 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 (count: < 4.0 x 109/L) 16) Thrombocytopenia at the time of screening (count: < 100 x 109/L) 17) History of other malignant diseases except for CML, including solid tumors and hematological malignancies (except basal cell and squamous cell carcinomas of the skin and carcinoma in situ of the cervix that has been completely excised and is considered cured) within the last 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropeginterferon1. 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 | Drug | randomized two-arm prospective study with/without Ropeginterferon in CML patients |
Primary outcome
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.
To assess the preventive efficacy of Ropeginterferon in Major Molecular Response (MMR) loss after TKI discontinuation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropeginterferon in people with CML (Chronic Myelogenous Leukemia), run by Dong-Wook Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.