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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT00004918
Eligibility Criteria:
Inclusion Criteria:
* Patients must be HLA-A2 positive at one allele
* Patients with CML in chronic phase or early accelerated phase, who are not eligible for BMT or interferon, or have failed standard therapy, or have relapsed after BMT
* Patients with MDS (FAB subtypes RAEB, and RAEBt) or AML in second or subsequent remission, or AML with a smoldering presentation and who are not candidates for chemotherapy, and who are believed to have a life expectancy of at least 9 weeks
* ECOG performance status \< 3
* Life expectancy is not severely limited by concomitant illness
* Serum bilirubin \< 3 mg/dl
* Serum creatinine \< 2 mg/dl
* ALT \< 3 x the upper limit of normal
* No serologic antibody against proteinase 3
* No known history of Wegener's granulomatosis or other vasculitis
* FEV, FVC, and DLCO \> 50% of predicted, and no symptomatic pulmonary disease
* Not pregnant; all female patients will have a serum pregnancy test, and only those that test negative will be allowed on study
* HIV negative
* No known allergic reaction to Montanide ISA 51 or Montanide ISA 51 VG adjuvant
* No active uncontrolled infection
* Patient or representative able to understand the study and consent
* Patient is not receiving steroids, cyclosporine, or FK-506 for at least 1 month prior to study entry and during study period
* No concomitant use of interferon or chemotherapy during study period other than hydroxyurea to control cell counts
* Patients who relapsed within one year of completing the initial vaccination could be retreated with up to 6 additional vaccinations if they remain eligible for treatment according to the original criteria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT00004918
Study Brief:
Protocol Section:
NCT00004918