Status:
COMPLETED
Long-acting Low Dose Ropeginterferon for Chronic Myeloid Leukemia Treated With Bosutinib From Diagnosis
Lead Sponsor:
St. Olavs Hospital
Collaborating Sponsors:
Haukeland University Hospital
Oslo University Hospital
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 leuk...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT03831776
Start Date
March 25 2019
End Date
December 31 2024
Last Update
June 8 2025
Active Locations (18)
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1
Aalborg university hospital
Aalborg, Denmark
2
Aarhus ...
Aarhus, Denmark
3
Copenhagen ...
Copenhagen, Denmark
4
Odense Universitetshospital
Odense, Denmark