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:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT01294618
Eligibility Criteria:
Inclusion Criteria:
* Performans status 0-2
* CP CML diagnosed since less than 3 months without previous Tyrosine Kinase Inhibitor (TKI) or interferon treatment
* Adequate organic functions:
* Total Bilirubin \< 1.5xUpper Normal Range (UNR).
* Aspartate Amino Transferase (ASAT) and Alanine Amino Transferase (ALAT) \< 2.5xUNR.
* Alkaline phosphatase ≤ 2.5xUNR
* Amylase and lipase ≤ 1.5xUNR.
* Creatininemia \< 1.5xUNR.
* Biological blood standards :
* Potassium ≥ Lower Normal Range (LNR)
* Magnesium ≥ LNR.
* Phosphorus ≥ LNR
* Calcium ≥ LNR.
* Negative pregnancy test within the last 7 days for women with childbearing potential.
* Informed consent signed up
* Compliance to tretament ensured,
* Valid social insurance
Exclusion Criteria:
Prior TKI or interferon treatment for the CML
* Contra-indication to IFN
* Pregnancy, breast feeding
* Human Immunodeficiency Virus positive, chronic hepatitis B or C.
* Other BCR-ABL transcript than M-bcr
* Cardiopathy defined as:
* Left Ventricular Ejection Fraction (LVEF) \< 45%.
* Left bundle branch block
* Ventricular pacemaker.
* Congenital prolonged QT
* Past ventricular or significant auricular tachyarrythmia
* Clinically significant bradycardia (\<50 per minute).
* QTc (Fredericia) \> 450 ms (average on 3 Elektrokardiogramm (EKG)).
* Myocardial infarction in the last 12 months.
* Unstable angina within the last 12 months.
* Other significant cardiac diseases.
* Other uncontrolled severe disease (such as diabetes melittus etc…)
* Other ongoing malignant disease.
* Past history of congenital or acquired clinically significant bleeding disorder.
* Previous radiotherapy ≥25% of bone marrow.
* Serious surgery within the past 4 weeks
* Investigational treatment within the last 30 days prior to day 1.
* History of non compliance.
* Cytochrome P450 3A4 (CYP3A4) inhibitors that could not be withdrawn or modified (such as erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil).
* Severe gastro-intestinal disorders (such as gastric ulcer, uncontrolled nausea, malabsorption syndrome, small intestine resection, gastric shunt).
* Hepatic, renal or pancreatic chronic disorder unrelated to CML
* Recent history of acute pancreatitis within a year or history of chronic pancreatic disease .
* Any concommittant treatment inducing QT prolongation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01294618
Study Brief:
Protocol Section:
NCT01294618