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 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT00129558
Eligibility Criteria:
Inclusion Criteria:
* Relapsed/refractory leukemias including acute non-lymphocytic leukemia (AML), acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), and chronic myelogenous leukemia in blastic phase (CML-BP) for which no standard therapies are anticipated to result in a durable remission; or poor-risk myelodysplasia (MDS) patients to include refractory anemia with excess blasts (RAEB) or excess blasts in transformation (RAEBT) and chronic myelomonocytic leukemia (CMML) who are either relapsed/refractory or who refuse/are not eligible for frontline therapy.
* Only patients with refractory ALL or CML in lymphoid blastic phase are eligible for phase II.
* ECOG performance status 0 - 2.
* Adequate organ function and bone marrow reserve.
* At least 4 weeks must have elapsed from the time of major surgery.
* Use of appropriate contraceptive method.
* Signed patient informed consent.
Exclusion Criteria:
* Known human immunodeficiency virus (HIV).
* Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure.
* Patients receiving any other standard or investigational treatment for their leukemia other than corticosteriods, hydroxyurea, and 6-mercaptopurine.
* Any medical condition which, in the opinion of the investigator, places the patient at an unacceptably high risk for toxicities.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00129558
Study Brief:
Protocol Section:
NCT00129558