PETALS study : PEgylated interferon-alpha2a and TAsigna® for first Line therapy of Philadelphia chromosome-positive chronic phase CML patientS - PETALS

Hospices Civils de Lyon0 个研究点目标入组 200 人开始时间: 2014年2月28日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•Chronic Myelogenous Leukemia - Chronic phase positive to the Philadelphia chromosome or BCR-ABL diagnosed less than 3 months prior to study entry
•Patient for whom treatment with Nilotinib is planned
•men and women patients age = 18 years
•ECOG score 0-2
•No other CML treatment except for hydroxyurea and/or anagrelide
•Without prior treatment with IFN or ITK (same for other purposes),
•AST and ALT <2.5 x ULN.
•Serum creatinine <2 x ULN
•No planned allogeneic stem cell transplantation
•Informed consent signed
•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 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•Transcripts other than M- Bcr
•Contra-indications to IFN including in particular ,
•Severe psychiatric / neurological disease (history or concomitant )
•Known concomitant autoimmune disease, including rheumatoid arthritis
•Uncontrolled thyroid disease
•Pregnancy, lactation
•HIV positivity, chronic hepatitis B or C
•History or concurrent malignancy other than CML , except if it is currently not clinically significant in terms of the investigator and requires no treatment .
•History of peripheral arterial disease or peripheral arterial disease , stroke , myocardial infarction or severe coronary artery disease.
•Diabetic patients with target organ damage .
•Permanent elevation of total cholesterol and triglycerides despite treatment
•Other product in the current study
•Current immunosuppressive therapy
•Patients receiving treatment may induce torsades de pointes.
•QTc ( Fredericia ) > 450 ms despite the correction of predisposing factors , congenital long QT syndrome
•No health insurance coverage

发起方