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 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT00534469
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of acute myeloid leukemia (AML)
* FAB types M0-2 and M4-M7
* No M3 disease
* In first complete hematological remission as confirmed by marrow aspiration and biopsy
* No cytogenetic abnormality in the remission marrow
* In complete remission for less than 6 months
* Patients who have been in complete remission for more than 6 months may be eligible upon approval of the principal investigator
* No prior myeloproliferative disorder (e.g., chronic myeloid leukemia, myelofibrosis, essential thrombocytosis, or polycythemia vera)
* No prior myelodysplasia or secondary leukemia
PATIENT CHARACTERISTICS:
* FEV\_1 \> 60%
* DLCO \> 50%
* Cardiac ejection fraction ≥ 50%
* Creatinine clearance \> 60 mL/min
* No severe chronic medical or psychological illness that, in the judgement of the principal investigator, would jeopardize the ability of the patient to tolerate aggressive chemotherapy
* No HIV positivity
* Not pregnant
* Negative pregnancy test
PRIOR CONCURRENT THERAPY:
* Prior consolidation therapy allowed
* No concurrent use the following medications during aldesleukin therapy :
* Corticosteroids (including blood product "pre-meds")
* Pentoxifylline
* IV or intrathecal methotrexate
* IV immunoglobulin
* Other cytokines or growth factors
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
60 Years
Study:
NCT00534469
Study Brief:
Protocol Section:
NCT00534469