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 @ 4:42 PM
Ignite Modification Date:
2025-12-24 @ 4:42 PM
NCT ID:
NCT00362466
Eligibility Criteria:
Inclusion Criteria:
* Men and women ≥18 years diagnosed with Chronic Phase Philadelphia chromosome positive (CP Ph+) CML who have failed to achieve CCyR after 3-18 months of therapy with imatinib 400 mg
* Treatment initiation with imatinib 400 mg within 6 months of initial CML diagnosis
* Able to tolerate chronic administration of imatinib at the highest dose (400-600 mg) the subject has received in the past
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2
* Adequate hepatic and renal function
Exclusion Criteria:
* Eligible and willing to undergo immediate autologous/allogeneic stem cell transplant
* Previous diagnosis of accelerated/blast crisis CML
* Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases
* Previous documentation of T315I mutation
* Uncontrolled or significant cardiovascular disease
* Serious uncontrolled medical disorder/active infection
* History of significant bleeding disorder unrelated to CML
* Intolerance to imatinib ≥400 mg
* Concurrent malignancies other than CML
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00362466
Study Brief:
Protocol Section:
NCT00362466