A study of effect and safety of a new combination of drugs for chronic myeloid leukemia in chronic phase. Bosutinib is the basis treatment and patients will be randomized to receive or not to receive a long-acting low dose of Ropeginterferon.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Not specified

Target Recruitment: 212

Inclusion Criteria

1)Signed written informed consent form (ICF) before any procedure related to the study
2)Target Population
a)Men and women, ages 18 to 75 years
b)Newly diagnosed (= 3 months) BCR-ABL positive chronic myeloid leukemia in chronic phase
c)Major BCR-ABL transcripts (p210 b2a2(e13a2) and/or b3a2(e14a2))
d)Not previously treated for CML except with hydroxyurea or anagrelide
e)ECOG Performance Status (ECOG PS) = 2
f)Adequate organ function.
i.Total bilirubin < 1,5 times the institutional Upper Limit of Normal (ULN)
ii.Hepatic enzymes ASAT and ALAT < 2 times the institutional ULN
iii.Serum Creatinine < 1.5 time the institutional ULN
iv.Lipase < 1.5 time the institutional ULN
3)Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study.
4)WOCBP must have a negative serum or urine pregnancy test at screening.
5)A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study to minimize the risk of pregnancy.
6)Free subject, without guardianship nor subordination
7)Health insurance coverage.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 145
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 67

Exclusion Criteria

1)Patients with BCR-ABL transcript other than M-BCR-ABL
2)Patients previously treated with tyrosine kinase inhibitors (TKIs).
3)Medical history and concurrent diseases:
a)Hypersensitivity to any of the excipients of BOS or RoPegIFN
b)Prior treatment with Interferon-a, contraindication to interferon-a,
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)
i)Other malignant disease during the last 5 years prior to the inclusion except non-melanoma skin carcinoma or carcinoma in situ of the cervix,
j)History of significant bleeding disorder unrelated to CML or diagnosed congenital bleeding disorder,
k)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.
4)Prohibited treatments and/or therapies: strong inhibitors/inducers of the CYP 3A4,
5)History / any condition for poor compliance to medical treatment.
6)Women who are pregnant or breastfeeding are not eligible for this study
7)Inability to freely provide consent through judiciary or administrative condition.
8)Ongoing participation to another clinical investigational study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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