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 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT00454168
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of acute myeloid leukemia (AML), defined by the presence of \> 20% blasts in marrow or blood, including the following subtypes:
* De novo AML, defined as AML with no clinical history of prior myelodysplastic syndromes (MDS) or myeloproliferative disorder (MPD) or exposure to potentially leukemogenic therapies or agents
* Secondary AML, defined as the following:
* AML secondary to prior existing MDS or MPD or development of AML secondary to proven leukemogenic exposure
* History of fatigue, bleeding, or recurrent infections preceding diagnosis of AML by ≥ 1 month with confirmation of existing peripheral blood film that demonstrates morphologic dysplasia
* In first complete remission (CR) (patients ≥ 55 years of age) OR second CR (patients ≥ 18 years of age) within the past month
* FAB stages M0-M2 and M4-M7 allowed if in first CR
* No acute promyelocytic leukemia in first CR
* FAB stages M0-M7 allowed if in second CR
* Marrow blast count \< 5% (≤ 200 nucleated cell count)
* No blasts in blood
* HLA-A2 positive at 1 allele
* No extramedullary disease
* No Auer rods
* No active meningeal or CNS leukemia
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Life expectancy must not be severely limited by other diseases
* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm\^3
* Bilirubin \< 2 mg/mL
* ALT \< 2 times upper limit of normal
* Creatinine ≤ 1.6 mg/mL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Antineutrophil cytoplasmic antibody negative
* No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study compliance or increase risk to patient
* No other malignancy within the past 5 years except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast
* No known allergy to incomplete Freund's adjuvant
* No hypercalcemia
* No progressive viral or bacterial infection
* Must be afebrile for 7 days without antibiotics
* No symptomatic cardiac disease
* LVEF ≥ 40%
* No symptomatic pulmonary disease
* FEV\_1, FVC, and DLCO ≥ 50% of predicated (without bronchodilator)
* No history of HIV positivity or AIDS
* No known hypersensitivity to sargramostim (GM-CSF), yeast-derived products, or any component of this product
* No history of Wegener's granulomatosis or vasculitis
PRIOR CONCURRENT THERAPY:
* Recovered from prior surgery and/or radiotherapy
* No prior allogeneic or syngeneic stem cell transplantation
* No prior solid organ transplantation
* No prior vaccine therapy for AML
* More than 28 days since prior chronic use (\> 2 weeks) of corticosteroids \> 10 mg/day (prednisone \[or equivalent\])
* Concurrent topical or inhaled corticosteroids allowed
* More than 3 months since prior experimental therapy, cyclosporine, or tacrolimus
* No concurrent radiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00454168
Study Brief:
Protocol Section:
NCT00454168