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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT00301093
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of chronic myelogenous leukemia
* Chronic phase disease
* Philadelphia chromosome positive disease
* Disease in first complete hematologic response, defined by all of the following:
* Complete normalization of peripheral blood counts with WBC \< 10,000/mm\^3
* Platelet count \< 450,000/mm\^3
* No immature cells (e.g., myelocytes, metamyelocytes, or blasts) in the peripheral blood
* Persistent molecular evidence of disease
* Detectable BCR-ABL transcript by quantitative polymerase chain reaction
* Less than 2 log reduction in peripheral blood or bone marrow BCR-ABL transcripts levels compared to a standardized baseline
* Must have received imatinib mesylate for \> 1 year of which the last 3 months were at stable dose ≥ 300 mg/day
PATIENT CHARACTERISTICS:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Negative pregnancy test
* No known HIV
* ALT or AST ≤ 3 times upper limit of normal
* Oxygen saturation ≥ 93% at room air
* No history of recent acute myocardial infarction
* No history of unstable angina
* No pulmonary decomposition requiring hospitalization within the past 3 months
* No concurrent and/or uncontrolled psychiatric or medical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior allogeneic stem cell transplantation
* At least 2 months since other prior experimental therapy
* At least 6 months since prior participation in another vaccine study
* No concurrent systemic immunosuppressive medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00301093
Study Brief:
Protocol Section:
NCT00301093