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 @ 4:51 AM
Ignite Modification Date:
2025-12-25 @ 4:51 AM
NCT ID:
NCT02551718
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of acute leukemia by World Health Organization (WHO) criteria (e.g.-acute myeloid leukemia, acute lymphoblastic leukemia, acute leukemia of ambiguous origin)
* Either:
* Relapsed after or refractory to prior treatment with at least two regimens or lines of treatment
* Prior failure of at least one regimen or line of treatment, with poor cytogenetic or other risk factors, and ineligible for other clinical trials
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 3
* Expectation that we can obtain about 10 million blasts from blood and/or marrow (e.g., circulating blast count of 5,000 or greater or cellular marrow with greater than or equal to 20% blasts)
* Bilirubin =\< 1.5 x upper limit of normal (ULN) unless elevation is thought to be due to Gilbert's syndrome, hemolysis, or hepatic infiltration by the hematologic malignancy
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamate pyruvate transaminase (SPGT) (alanine aminotransferase \[ALT\]) =\< 2.5 x ULN, unless elevation is thought to be due to hepatic infiltration by the hematologic malignancy
* Alkaline phosphatase =\< 2.5 x ULN, unless elevation is thought to be due to hepatic infiltration by the hematologic malignancy
* Serum creatinine =\< 2.0 mg/dL
* Informed consent
* Willing to use contraception when appropriate
* Expected survival is greater than 100 days
Exclusion Criteria:
* No other active cancer that requires systemic chemotherapy or radiation
* Active systemic fungal, bacterial, viral or other infection, unless disease is under treatment with antimicrobials and considered controlled in the opinion of the investigator
* Significant organ compromise that will increase risk of toxicity or mortality
* Pregnancy or lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Study:
NCT02551718
Study Brief:
Protocol Section:
NCT02551718