EUCTR2018-001044-54-NO招募中1 期
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 - BosuPeg
St Olavs Hospital -Trondheim University Hospital0 个研究点目标入组 212 人开始时间: 2018年7月18日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 212
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
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