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 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT02016833
Eligibility Criteria:
Inclusion Criteria:
* Specific Inclusion criteria
* For ovarian cancer patients: Histologically confirmed surgical diagnosis of high-grade serous (or undifferentiated) ovarian cancer
* For CIN3 and cervical cancer patients: Histologically confirmed diagnosis of CIN3 or cervical cancer
* For AML and CML patients: HLA-A2 positivity and diagnosis of AML or CML confirmed by bone marrow biopsy or peripheral blood
* Shared inclusion criteria
* No evidence of active progressive disease. For ovarian cancer patients, a woman with a rising CA125 and negative imaging is acceptable
* Age ≥ 18 yrs and \< 70 yrs
* ECOG 0-2
* Adequate hematologic assessment (results from the previous standard of care visit):
* Absolute neutrophil count (ANC) greater than or equal to 1.0 x 109/L
* Platelets greater than or equal to 100 x 109/L.
* Written informed consent
Exclusion Criteria:
* Treatment with chemotherapy, radiation therapy, other immunotherapy or non-topical steroids within the past 3 weeks prior to initiation of the study.
* Immunosuppressive therapy (excluding topical steroids) for any other condition.
* Recurrent/progressive disease confirmed clinically, radiologically or histologically before entry into the study. (exclude versus inclusion criteria)
* Persistent fever (\>24 hours) documented by repeated measurement or active uncontrolled infection in the last 4 weeks.
* Active autoimmune disease, including, but not limited to, SLE, MS, ankylosing spondylitis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02016833
Study Brief:
Protocol Section:
NCT02016833