Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT02201459
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients
* CP-CML, positive Philadelphia chromosome or positive BCR-ABL (M-bcr transcript), diagnosed less than 3 months prior to study entry
* Age of at least 18 years-old and less than 65 years
* Patient for whom treatment with Nilotinib is expected
* No other CML treatment except for hydroxyurea and/or anagrelide
* No previous TKI treatment.
* No previous treatment with IFN even for other purposes.
* SGOT and SGPT \< 2.5 UNL
* Serum creatinine \< 2 UNL
* No planned allogeneic stem cell transplantation
* Signed informed consent
* ECOG score 0 to 2
Exclusion Criteria:
* Contra-indication to IFN
* Transcripts other than M-Bcr
* Pregnancy, lactation
* HIV positivity, chronic hepatitis B or C.
* Prior or concurrent malignancy other than CML (exceptions to be mentioned)
* History of arterial occlusive disease or (peripheral, carotids or severe coronary heart disease).
* Permanent elevation of total cholesterol and triglycerides despite treatment
* Severe psychiatric/neurological disease (previous or ongoing)
* Concomitant auto-immune disease
* Other investigational product ongoing
* Ongoing immunosuppressive treatment
* Ongoing treatment at risk for inducing torsades de pointes
* QTcF \> 450ms despite correction of predisposing factors (i.e electrolytes…)
* Congenital long QTcF
* Unstabilised thyroid disorder
* No health insurance coverage
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02201459
Study Brief:
Protocol Section:
NCT02201459