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 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT02842827
Eligibility Criteria:
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
High-risk Acute Myeloid Leukemia (AML)
* Have a diagnosis of AML according to the World Health Organization (WHO) criteria
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
* Have AML that is classified as high risk as defined by one of the following: ≥ 60 years of age who were not candidates for or have refused standard chemotherapy; ≥18 years of age with de novo or secondary AML who were not expected to benefit from standard remission-induction chemotherapy; or had relapsed/refractory AML after no more than 3 previous lines of chemotherapy.
High-risk Myelodysplastic Syndromes (MDS)
* Have a diagnosis of myelodysplastic syndromes according to the World Health Organization (WHO) criteria
* Have either an International Prognostic Scoring System (IPSS) score equivalent to intermediate-2 risk or higher, or a Revised International Prognostic Scoring System (IPSS-R) score equivalent to intermediate risk or higher.
* Have MDS that is classified as high risk as defined by one of the following: participants who have failed first-line therapy; or treatment-related MDS, except if it is associated with favorable cytogenetics, and not a candidate for stem cell transplantation
* Prior autologous stem cell transplant is allowed if a minimum of 3 months has elapsed from the time of transplant and the patient has recovered from transplant-associated toxicities
* Prior allogeneic stem cell transplant is allowed, provided all of the following criteria are met: transplant was \>120 days prior to study enrollment; no immunosuppressive medications have been taken for at least 1 month; and no active graft versus host disease (GVHD), excluding Grade 1 skin GVHD
* Has a life expectancy \>12 weeks
Exclusion Criteria:
* Is receiving other treatments for the condition (with exceptions and time limits)
* Has had major surgery in last 4 weeks or minor surgery in the last 2 weeks
* Has a scheduled hematopoietic stem-cell transplant
* Is currently using prohibited medications
* Has clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS leukemia
* Has a concurrent second active and non-stable malignancy
* Has an uncontrolled active infection
* Has known Human Immunodeficiency Virus (HIV) infection or active Hepatitis B or Hepatitis C virus infection
* Has used an investigational agent within last 14 days
* Is a pregnant or lactating females
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02842827
Study Brief:
Protocol Section:
NCT02842827