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 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT00858806
Eligibility Criteria:
Inclusion Criteria:
1. Patients with confirmed diagnosis of Ph+ CML in CP
2. Age ≥ 65 years old
3. Stable CCgR after at least 2 years of treatment with standard (daily administration) IM therapy documented by 2 consecutive cytogenetic analysis over the last 12 month
4. Karnofsky performance status \>50%
5. Written informed consent prior to any study procedures being performed.
Exclusion Criteria:
1. Patients with Ph+ CML in accelerated/blastic phase (AP/BP), or in late CP, previously treated (i.e. IFN alpha+/- low dose Ara-C, Hydroxyurea, allogeneic stem cell transplantation, etc etc.)
2. Age \< 65 years old
3. No stable CCgR after at least 2 years of treatment with standard (daily administration) IM therapy documented by 2 consecutive cytogenetic analysis over the last 12 month
4. Karnofsky performance status \<50%
5. No written informed consent prior to any study procedures being performed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT00858806
Study Brief:
Protocol Section:
NCT00858806