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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT00003694
Eligibility Criteria:
Inclusion Criteria:
* Histologic diagnosis of chronic myelogenous leukemia (CML) in chronic phase; patients in either accelerated or blastic phases are not eligible; clonal cytogenetic evolution alone does not exclude patients
* Patients must meet one or more of the following criteria:
* Cytogenetically determined Philadelphia chromosome (Ph+)
* BCR/ABL protein detectable by immunoblotting
* Polymerase chain reaction (PCR) positive fusion transcripts for BCR/ABL
* BCR/ABL translocation present by fluorescence in situ hybridization (FISH)
* Registration within eight weeks of the diagnosis and confirmation of Ph+ or BCR/ABL+ CML
* No more than eight weeks of prior hydroxyurea therapy
* No previous therapy with homoharringtonine (HHT)
* No prior treatment for CML with agents other than hydroxyurea; thus, prior treatment for CML with agents such as interferon, busulfan or cytarabine will render patients ineligible
* Must not be a candidate for an early allogeneic bone marrow transplant; potential transplant candidates must be counseled about alternative donor transplants and must decline that treatment option
* ECOG performance status 0-2
* Non-pregnant and non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control
* Bilirubin =\< x upper limit of normal
* Creatinine =\< 1.5 mg/dl
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00003694
Study Brief:
Protocol Section:
NCT00003694