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 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT02040506
Eligibility Criteria:
Inclusion Criteria:
* Relapsed or treatment-refractory AML
* Eastern Cooperative Oncology Group status 0-2
* Life expectancy of at least 12 weeks
* Adequate baseline renal and hepatic function
* Measurable disease (eg, peripheral blasts greater than 5%)
Exclusion Criteria:
* Chronic myelogenous leukemia in blast crisis
* Monoclonal therapy within 4 weeks, or chemotherapy or radiotherapy within 2 weeks
* Unresolved acute toxicity from prior anti-cancer therapy
* Prior allogeneic stem cell transplant and active graft-versus-host disease requiring systemic immunosuppressive therapy within 15 days prior to screening
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
* Known current leptomeningeal or central nervous system (CNS) involvement of leukemia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02040506
Study Brief:
Protocol Section:
NCT02040506