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Chronic Myeloid LeukemiaPhase 2BosuPegNCT03831776

Long-acting Low Dose Ropeginterferon for Chronic Myeloid Leukemia Treated With Bosutinib From Diagnosis

A Phase 2 study testing Bosutinib and Ropeginterferon in people with Chronic Myeloid Leukemia, run by St. Olavs Hospital at 18 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To study the efficacy and safety of combination of Ro-Peg-interferon-α2b (RoPegIFN) with Bosutinib (BOS) in comparison to BOS monotherapy, as frontline therapy for newly diagnosed chronic myeloid leukemia patients, and to estimate efficacy of the addition of RoPegIFN to BOS in terms of deep molecular response with the… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Myeloid Leukemia
What is being tested?
Bosutinib and Ropeginterferon
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
18 sitesin 4 countries
Study dates
25 Mar 2019to 31 Dec 2024
Phase
Phase 2
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent form (ICF) before any procedure related to the study
  • Newly diagnosed (≤ 3 months) BCR-ABL positive chronic myeloid leukemia (CML) in chronic phase
  • Major BCR-ABL transcripts (p210 b2a2(e13a2) and/or b3a2 (e14a2)
  • Not previously treated for CML except with hydroxyurea or anagrelide
  • ECOG Performance Status (ECOG PS) ≤ 2
  • Adequate organ function: Total bilirubin < 1,5 times the institutional Upper Limit of Normal (ULN); Hepatic enzymes ASAT and ALAT < 2 times the institutional ULN; Serum Creatinine < 1.5 time the institutional ULN; Lipase < 1.5 time the institutional ULN
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  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study.
  • WOCBP must have a negative serum or urine pregnancy test at screening.
  • Free subject, without guardianship nor subordination
  • Health insurance coverage

Who cannot join

  • Patients with BCR-ABL transcript other than M-BCR-ABL
  • Patients previously treated with tyrosine kinase inhibitors (TKIs).
  • Inability to freely provide consent through judiciary or administrative condition.
  • Ongoing participation to another clinical investigational study.
  • Medical history and concurrent diseases: a) Hypersensitivity to any of the excipients of BOS or RoPegIFN, b) Prior treatment with Interferon-α, contraindication to interferon-α, c) Autoimmune disorder, concomitant immunosuppressive treatment or corticosteroids, d) Pre-existing thyroid disease unless controlled with conventional treatment, auto-immune thyroiditis, e) Chronic liver disease, f) Prior or ongoing severe psychiatric disease, g) HIV positivity, chronic hepatitis B or C, h) Uncontrolled or severe cardiac (NYHA Class III or IV) or pulmonary disease, echocardiography with LVF < 45% or LLN, peak velocity of tricuspid regurgitant flow > 2,8 m/s, pulmonary arterial hypertension (PAH), QTc>450 ms (by Barrets correction)
  • Other malignant disease during the last 5 years prior to the inclusion except non-melanoma skin carcinoma or carcinoma in situ of the cervix,
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  • History of significant bleeding disorder unrelated to CML or diagnosed congenital bleeding disorder,
  • Subjects with an uncontrolled undercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol.
  • Prohibited treatments and/or therapies: strong inhibitors/inducers of the CYP 3A4,
  • History / any condition for poor compliance to medical treatment.
  • Women who are pregnant or breastfeeding are not eligible for this study

Trial locations and contacts

18 sites in 4 countries.

18 sites in 4 countries

Sweden8 sites

  • Göteborg ....

    Gothenburg

  • Universitetssjukhuset Linköping

    Linköping

  • Skåne University Hospital

    Lund

  • Universitetssjukhuset Örebro

    Örebro

  • Karolinska Universitetssjukhus

    Stockholm

  • Sundsvall ...

    Sundsvall

  • Norrlands Universitetssjukhus

    Umeå

  • University Hospital

    Uppsala

Other trials in Sweden

Norway5 sites

  • Haukeland Universitetssjukehus

    Bergen

  • Oslo Universitetssykehus

    Oslo

  • Stavanger Universitetssjukehus

    Stavanger

  • Universitetssykehuset Nord Norge

    Tromsø

  • St Olavs Hospital

    Trondheim

Other trials in Norway

Denmark4 sites

  • Aalborg university hospital

    Aalborg

  • Aarhus ...

    Aarhus

  • Copenhagen ...

    Copenhagen

  • Odense Universitetshospital

    Odense

Other trials in Denmark

Finland1 site

  • Comprehensive Cancer Center, Hematology

    Helsinki

Other trials in Finland

About this study

Official title: A Study of Efficacy and Safety of Long-acting Low Dose Ropeginterferon in Patients With Chronic Myeloid Leukemia Treated With Bosutinib From Diagnosis: a Randomized Prospective Trial

To study the efficacy and safety of combination of Ro-Peg-interferon-α2b (RoPegIFN) with Bosutinib (BOS) in comparison to BOS monotherapy, as frontline therapy for newly diagnosed chronic myeloid leukemia patients, and to estimate efficacy of the addition of RoPegIFN to BOS in terms of deep molecular response with the aim of increasing the proportion of patients who may achieve treatment free remission. (NCMLSG study #NordCML012)

Being tested
Bosutinib, Ropeginterferon
Keywords
Bosupeg, Ropeginterferon
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.

  • BosutinibDrug

    Bosutinib, provided by Pfizer, starting dose of 200mg QD and stepwise dose escalation (> 300 mg/d > 400 mg/d) during the first three months. A pharmacological study will be performed in the French cohort (BOSUSTEP Substudy). BOS residual plasma concentration (Cmin) will be checked after initiation, before each dose step in the French cohort, and at M3 also for Nordic patients in ancillary studies.

  • RopeginterferonDrug

    Also called RoPegIFN

    Ro-Peg-Interferon α2b will be supplied by AOP Orphan to be administered by subcutaneous injections from prefilled injection pens. RoPegIFN will be given in an open-label fashion. Patients assigned to RoPegIFN will start with 50 μg injected subcutaneously every 14 days, in combination with Bosutinib.

Study groups in NCT03831776
Study groupRoleWhat they receive
Bosutinib-Ropeginterferon combinationExperimentalNot described
Receives: Drug: Bosutinib; Drug: Ropeginterferon
Bosutinib monotherapyActive comparatorNot described
Receives: Drug: Bosutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of molecular response 4 (MR4)

    Molecular response 4 (MR4) is defined by either a positive BCR-ABL/ABL ratio ≤ 0.01% on the international scale (IS) or by undetectable BCR-ABL with the analysis of at least 10000 copies of ABL or 24000 copies of GUS (according to the ELN recommendations by N. Cross et al., Leukemia 2015)

    Measured: 12 months

Secondary outcomes (12)

  1. Rate of molecular response MR2, MR3, MR4, MR4.5 from 1 month up to 24 months and every 6 months thereafter

    Measured: 2 years

  2. Cumulative incidence of molecular response MR3, MR4, MR4.5

    Measured: 2 years

  3. Rate of complete cytogenetic response (CCyR) up to 12 months

    Measured: 12 months

  4. Rate of undetectable molecular response for patients who achieved molecular response MR4 and MR4.5

    Measured: 2 years

  5. Time to and duration of CCyR, MR3, MR4, MR4.5

    Measured: 2 years

  6. proportion of patients eligible for randomization after 3 months of Bosutinib

    Measured: 3 months

  7. rate and characteristics of severe adverse events (SAE)

    type and grade according to the NCI CTCAE v4.03

    Measured: 2 years

  8. Dose intensity of RoPegIFN and Bosutinib

    Measured: 2 years

  9. Cumulative incidence of discontinuation of the therapies, incl. reasons for discontinuation

    Measured: 2 years

  10. Quality of life assessment by QLQC30 questionnaire up to 6 years at key time point (Day 1, month 3, month 6, month 12, month 24, month 48, month 54, month 72)

    Measured: 6 years

  11. Quality of life assessment by CML24 questionnaire up to 6 years at key time point (Day 1, month 3, month 6, month 12, month 24, month 48, month 54, month 72)

    Measured: 6 years

  12. The proportion of patients achieving a durable deep molecular response and being eligible for treatment discontinuation at month 48

    Sustained deep molecular response (MR) criteria will be defined according updated data and ELN guidelines before the first patient will achieve month 48 (at least a MR4 over a 12 months period and confirmed on the last centralized measurement at month 48

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2019
  2. Study start25 Mar 2019
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03831776
Sponsor's protocol ID
BosuPeg TRIAL
Other IDs
2018-001044-54, 2018
Acronym
BosuPeg
Status last verified
Jun 2025
First submitted
4 Feb 2019
Last updated
8 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bosutinib and Ropeginterferon in people with Chronic Myeloid Leukemia, run by St. Olavs Hospital at 18 sites in 4 countries.

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 10 inclusion and 11 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 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Sweden, Norway, Denmark, Finland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Rate of molecular response 4 (MR4) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03831776.

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 8 Jun 2025.

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