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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT01096602
Eligibility Criteria:
Inclusion Criteria:
Screening:
* Patients with AML at initial diagnosis or at first relapse
* 18 years of age or older
* ECOG Performance Status 0-2
* Life expectancy of greater than 9 weeks
* Laboratory values within limits outlined in the protocol
* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
Prior to Cell Collections for Dendritic Cell Generation:
* Patients must have obtained complete remission with chemotherapy defined by the absence of circulating blasts, and less then 5% blasts on bone marrow examination following hematopoietic recovery
* Resolution of all chemotherapy related Grade III-IV toxicity as per CTC criteria 4.0
* Laboratory values as outlined in the protocol
* For patients with evidence of minimal residual disease prior to vaccination, assessment of minimal residual disease status by cytogenetics or FISH will be followed post vaccination
Prior to Post-Chemotherapy Immunotherapy:
* Resolution of all chemotherapy related grade III-IV toxicity
* Laboratory values as outlined in the protocol
* At least 2 doses of fusion vaccine produced
Exclusion Criteria:
Screening:
* Active or history of autoimmune disorders/conditions including Type 1 diabetes. Type II diabetes, vitiligo or stable hyperthyroidism will not be considered exclusion criteria
* HIV positive
* Significant cardiac disease characterized by symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia
* Pregnant women
* Individuals with a history of a different malignancy are ineligible except for circumstances outlined in the protocol document
Prior to Cell Collection for Dendritic Cell Generation:
* Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
* Patients who choose to proceed with allogeneic or autologous transplant at the time of remission will not be vaccinated and will come off study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01096602
Study Brief:
Protocol Section:
NCT01096602