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:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-26 @ 5:22 PM
NCT ID:
NCT01933906
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥ 18 years of age
* BCR-ABL positive chronic myeloid leukaemia in chronic phase treated with imatinib as first line therapy
* CHR, CCyR after at least 18 months of imatinib treatment
* Adequate organ function, defined as the following:
* total bilirubin \< 1.5 x ULN,
* AST and ALT \< 2.5 x ULN,
* creatinine \< 1.5 x ULN,
* ANC \> 1.5 x 109/L,
* platelets \> 100 x 109/L
* Written, voluntarily signed informed consent
Exclusion Criteria:
* CMR (molecular remission 4.5 or BCR-ABL transcripts undetectable)
* Patient has received any other investigational treatment within 28 days before study entry
* Treatment with a second generation tyrosine kinase inhibitor (dasatinib, nilotinib)
* ECOG performance status ≥ 3
* Patients with a primary of a different histological origin than the study indication (unless relapse-free interval is ≥ 5 years, except cervical carcinoma, basal cell epithelioma or squamous cell carcinoma of the skin)
* Evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease etc.)
* Acute chronic infections
* Known autoimmune disease (e.g. collagen disease, polyarthritis, immune thrombocytopenia, thyroiditis, psoriasis, lupus nephritis or any other autoimmune disorder)
* Female patients who are pregnant or breast-feeding
* Known diagnosis of HIV
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01933906
Study Brief:
Protocol Section:
NCT01933906