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

Korábbi kezelés

• Patients previously treated with tyrosine kinase inhibitors (TKIs).
• Other malignant disease during the last 5 years prior to the inclusion except non-melanoma skin carcinoma or carcinoma in situ of the cervix,
• 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,

Más betegség

• Inability to freely provide consent through judiciary or administrative condition.
• History of significant bleeding disorder unrelated to CML or diagnosed congenital bleeding disorder,
• History / any condition for poor compliance to medical treatment.

Laborértékek

• 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)

Egyéb

• Patients with BCR-ABL transcript other than M-BCR-ABL
• Ongoing participation to another clinical investigational study.
• Women who are pregnant or breastfeeding are not eligible for this study

• 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