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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT00665002
Eligibility Criteria:
Inclusion Criteria:
* Cytologic or histologic diagnosis of acute myelogenous leukemia or myelodysplastic syndrome confirmed at Moffitt Cancer Center.
* Patients with acute myelogenous leukemia will have completed induction chemotherapy, achieved first complete remission (CR) 1 or 2, and will have completed any planned postremission therapy (at discretion of treating physician),with no plan for allogenic or autologous transplant.
* Patients with myelodysplastic syndrome who according to the International Prognostic Scoring System (IPSS) are category Int-2 or greater, with disease that relapsed, progressed, or not responded to at least 1 prior course of approved therapy for MDS (i.e. hypomethylating agent or lenalidomide).
* Patients with AML/MDS must have documented WT-1 + disease. For purposes of this study, this may be either the demonstration of WT-1 protein on a pretreatment bone marrow biopsy or detectable disease with RQ-PCR. For patients in whom a bone marrow aspirate is not available or possible (e.g. "dry tap"), a peripheral blood sample may be used for WT-1 screening. In such cases, 10 cc of peripheral blood will be collected in a heparinized tube.
* At least 4 weeks must have elapsed between the patient's last chemotherapy or radiation treatment and the first vaccination.
* Karnofsky performance status ≥ 70%
* Hematologic parameters:
* Absolute neutrophil count ≥ 1000/mcL (except for MDS, for which the parameter is ≥ 500/mcL)
* Platelets \> 50 K/mcL (except for MDS for which the parameter is \> 25 K/mcL and not transfusion dependent)
* Biochemical parameters:
* Total bilirubin ≤ 2.0 mg/dl
* Aspartic transaminase (AST) and Alanine transaminase (ALT) ≤ 2.5 x upper limits of normal
* Creatinine ≤ 2.0 mg/dl
Exclusion Criteria:
* Pregnant or lactating women
* Patients with leptomeningeal disease
* Patients with active infection requiring systemic antibiotics, antiviral, or antifungal treatments
* Patients with serious unstable medical illness
* Patients taking systemic corticosteroids
* Patients with central nervous system (CNS) involvement with cancer/leukemia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00665002
Study Brief:
Protocol Section:
NCT00665002