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 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
NCT ID:
NCT00488592
Eligibility Criteria:
* INCLUSION CRITERIA:
Diagnosed with MDS (B subtypes Refractory anemia (RA), Refractory anemia with ring sideroblasts (RARS) -Low Risk) (MDS with 5q- must have failed lenalidomide or been ineligible to receive it)
OR
Diagnosed with AML and in complete remission within 5 years of treatment with less than 5% marrow blasts
OR
Diagnosed with CML in chronic phase
Unsuitable for stem cell transplantation (SCT) (age over sixty or unavailability of a fully-matched donor)
or
made an informed decision not to undergo the transplant procedure
or
are between 6 months 3 years following allogeneic SCT and fulfill the following criteria:
100% donor engraftment,
Less than 5% blasts in marrow
normal marrow cellularity
Human leukocyte antigen (HLA-A020 1) positive at one allele
Ages 18-85 years old
Off all lympho-ablative chemotherapeutic agents
EXCLUSION CRITERIA:
* Hypoplastic MDS
* Relapsed AML
* CML in accelerated phase or blast crisis
* Hypocellular bone marrow (less than 20%)
* History of Wegener's granulomatosis
* Serologic antibody against proteinase-3 (ANCA positive)
* Previous allergic reaction to Montanide Adjuvant
* Positive test for HIV
* Treatment with systemic corticosteroids or immunosuppressants within 14 days prior to study entry
* Co-morbidity of such severity that it would preclude the patient's ability to tolerate protocol therapy
* Predicted survival less than 28 days
* Pregnant or breast feeding (All female patients must have a urine pregnancy test within 1 week prior to vaccine administration)
* Unwilling to practice abstinence or effective contraception (men and women) during the study period.
* Enrolled in another drug or vaccine clinical trial during the study period
* Inability to comprehend the investigational nature of the study and provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00488592
Study Brief:
Protocol Section:
NCT00488592