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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT00511303
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients \* 18 years of age.
2. Patients with Ph chromosome positive CML in the chronic-phase of the disease.
3. Patients must have documented resistance to an interferon-alpha containing therapy, defined as any of the following:
1. Hematologic Resistance - Failure to achieve a complete hematologic response, lasting for at least 1 month despite of 6 or more months of an interferon-alpha containing regimen.
2. Cytogenetic Resistance - Bone marrow cytogenetics showing \*65% Ph chromosome positivity after at least one year of interferon-alpha based therapy
3. Cytogenetic Refractoriness - An increase in the Ph+ chromosome bone marrow cells by at least 30 percentage points (eg., from 20% to 50%, or from 30% to 60%) confirmed by two samples at least 1 month apart, or an increase to \* 65%
4. Hematologic Refractoriness - A rising WBC count (\*100% increase and to a level \*20 x 109/L confirmed by two samples taken at least two weeks apart) while receiving an interferon-alpha containing regimen.
4. Patients who have demonstrated intolerance to interferon-alpha therapy defined as: a documented \* Grade 3 non-hematologic toxicity (grade 2 in case of neurologic or neuropsichiatric toxicity), persisting for more than 2 weeks, in a patient receiving an interferon-alpha containing regimen. Patients who are intolerant to interferon-alpha must be more than 3 months from time of diagnosis.
5. Written voluntary informed consent.
Exclusion Criteria:
1. Patients of childbearing potential without a negative pregnancy test prior to the initiation of study drug. Barrier contraceptive precautions are to be used throughout the trial in both sexes.
2. Serum bilirubin and creatinine concentrations more than twice the upper limit of the normal range.
3. SGOT and SGPT more than twice the upper limit of the normal range.
4. Percentage of blasts, or basophils in the peripheral blood or bone marrow \> 15%.
5. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow ( 30%.
6. Patients with a platelet count \< 100 x 109/L
7. Patients with an ECOG Performance Status Score \* 3.
8. Patients receiving busulfan within 6 weeks of Visit 1.
9. Patients receiving treatment with interferon-alpha within 14 days of Visit 1.
10. Patients receiving treatment with cytosine arabinoside within 14 days of Visit 1.
11. Patients receiving treatment with hydroxyurea within 7 days of Visit 1.
12. Patients who have received other investigational agents within 28 days of Visit 1.
13. Patients with Grade 3/4 cardiac problems as defined by the New York Heart Association Criteria.
14. Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.
15. Patients who are likely to be submitted to any transplantation procedure during the study period (12 months)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00511303
Study Brief:
Protocol Section:
NCT00511303