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:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
NCT ID:
NCT02483312
Eligibility Criteria:
Inclusion Criteria:
* Patient with AML and \>=18 years of age.
* Agrees to participate in the study and signs the informed consent
* Viable cells are available for successful modification
* First or higher complete remission and have high risk features of relapse.
* Patients who have received prior treatment and are not in remission must have stable white blood cell count and are not receiving any chemotherapy or desiring further intensive treatment.
* Less than 10% blast cells in the bone marrow following induction or re-induction therapy and not desiring further intensive treatment.
* Acceptable creatinine, Aspartate transaminase (AST), Alkaline phosphatase (ALP), bilirubin lab results.
* Agree to use contraception
* Not pregnant
* Able to comply with study procedures
Exclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status \>2
* Known persistent infection
* Known central nervous system (CNS) disease
* Greater than 10% blasts in the bone marrow or circulating blast cells
* Life expectancy \< 2 months
* Receiving any chemotherapy, corticosteroids, Cox2 inhibitors or any non-drug therapies with the intent of altering the immune response or kill leukemic cells within one week prior to infusion of IL-12, except azacytidine.
* Patients who are HIV positive.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02483312
Study Brief:
Protocol Section:
NCT02483312