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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT00376467
Eligibility Criteria:
Inclusion Criteria:
* Patients with Ph +ve and/or BCR/ABL +ve ALL, either in 1st CHR (independently from the molecular status) for study A, or at diagnosis and untreated for study B;
* Age \>18 years and \<60 for study A, \>60 for study B;
* Written voluntary informed consent.
Exclusion Criteria:
* Patients of childbearing potential without a negative pregnancy test prior to the initiation of study. Barrier contraceptive precautions are to be used throughout the trial in both sexes;
* Pretreatment with steroids for more than 10 days in study B;
* Serum bilirubin and creatinine values \>3 the upper limit of normal range;
* SGOT and SGPT values \>3 the upper limit of the normal range;
* Patients who had received any other investigational agent within 4 weeks before the enrollment;
* Patients with cardiovascular diseases grade \>3 according to the New York Heart Association (see Appendix 1);
* Patients with a history of non compliance to medical regimen or who are considered potentially unreliable;
* Patients with moderate/severe mood or psychiatric disorders;
* Concomitant neoplasia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00376467
Study Brief:
Protocol Section:
NCT00376467