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:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT02083250
Eligibility Criteria:
Inclusion Criteria:
* Patients with biopsy-proven acute lymphoblastic leukemia, acute myeloid leukemia, or myelodysplastic syndrome in remission or relapse
* Estimated creatinine clearance at least 50 ml/min
* Bilirubin equal or less than 1.5 (unless Gilbert's syndrome)
* Serum glutamate pyruvate transaminase (SGPT) \< 3 x upper limit of normal
* Alkaline phosphatase \< 2 x upper limit of normal
* Pulmonary function with forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO) at least 45% of expected corrected for hemoglobin; children unable to perform pulmonary functions must have an oxygen saturation greater than 92% at room air
* Left ventricular ejection fraction at least 45% on appropriate medical therapy; no uncontrolled arrhythmias or symptomatic cardiac disease
* Zubrod performance status 0-1 or Lansky/Karnofsky performance status (PS) equal or greater to 80%
* Patients must have a related, genotypically HLA identical donor, or they must have an unrelated donor who is 8/8 HLA match by high resolution typing
* Patient or patient's legal representative, parent(s) or guardian should provide written informed consent; assent of a minor if participant's age is at least seven and less than eighteen years
* Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months and no previous surgical sterilization
Exclusion Criteria:
* Patients with active central nervous system (CNS) disease
* Evidence of acute or chronic active hepatitis or cirrhosis
* Uncontrolled infection, including human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV)-1, hepatitis B or hepatitis C viremia
* Prior allogeneic SCT
* Prior autologous SCT in last 12 months
* Patients with acute myeloid leukemia (AML) in first remission after one course of induction and with favorable cytogenetics (t\[8;21\], inv 16, or t\[15;17\]) and/or molecular profile (nucleophosmin \[NPM\]1)
* Prior radiation to liver in form of total body or involved field
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
60 Years
Study:
NCT02083250
Study Brief:
Protocol Section:
NCT02083250