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)
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.