Combining Ropeginterferon with Bosutinib for Chronic Myeloid Leukemia

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

This study is testing if combining two drugs, Ropeginterferon and Bosutinib, can help newly diagnosed patients with chronic myeloid leukemia do better than using Bosutinib alone.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 212 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: St. Olavs Hospital (Academic / other)
• Drugs / interventions: Bosutinib
• Locations: 18 sites (Aalborg and 17 other locations)
• Trial ID: NCT03831776 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of using Ropeginterferon-α2b in combination with Bosutinib as a first-line treatment for patients newly diagnosed with chronic myeloid leukemia (CML). It aims to compare this combination therapy to Bosutinib alone, focusing on achieving deeper molecular responses and increasing the likelihood of treatment-free remission. The trial includes patients who are within three months of their CML diagnosis and have specific BCR-ABL transcript types. Participants will be monitored for their response to the treatment and overall health outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults newly diagnosed with BCR-ABL positive chronic myeloid leukemia in chronic phase who have not received prior treatment.

Not a fit: Patients with BCR-ABL transcripts other than the specified major types will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment outcomes for patients with chronic myeloid leukemia by increasing the chances of achieving remission without ongoing therapy.

How similar studies have performed: Previous studies have shown promise in using combination therapies for chronic myeloid leukemia, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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,
* 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

Where this trial is running

Aalborg and 17 other locations

• Aalborg university hospital — Aalborg, Denmark (Not_yet_recruiting)
• Aarhus ... — Aarhus, Denmark (Not_yet_recruiting)
• Copenhagen ... — Copenhagen, Denmark (Not_yet_recruiting)
• Odense Universitetshospital — Odense, Denmark (Not_yet_recruiting)
• Comprehensive Cancer Center, Hematology — Helsinki, Finland (Not_yet_recruiting)
• Haukeland Universitetssjukehus — Bergen, Norway (Recruiting)
• Oslo Universitetssykehus — Oslo, Norway (Recruiting)
• Stavanger Universitetssjukehus — Stavanger, Norway (Recruiting)
• Universitetssykehuset Nord Norge — Tromsø, Norway (Recruiting)
• St Olavs Hospital — Trondheim, Norway (Recruiting)
• Göteborg .... — Göteborg, Sweden (Not_yet_recruiting)
• Universitetssjukhuset Linköping — Linköping, Sweden (Not_yet_recruiting)
• Skåne University Hospital — Lund, Sweden (Not_yet_recruiting)
• Karolinska Universitetssjukhus — Stockholm, Sweden (Not_yet_recruiting)
• Sundsvall ... — Sundsvall, Sweden (Not_yet_recruiting)
• Norrlands Universitetssjukhus — Umeå, Sweden (Not_yet_recruiting)
• University Hospital — Uppsala, Sweden (Not_yet_recruiting)
• Universitetssjukhuset Örebro — Örebro, Sweden (Not_yet_recruiting)

Study contacts

• Principal investigator: Henrik Hjorth-Hansen, md phd — St. Olavs Hospital
• Study coordinator: Henrik Hjorth-Hansen, md phd

Conditions Chronic Myeloid Leukemia; Bosupeg; Ropeginterferon