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 @ 4:23 PM
Ignite Modification Date:
2025-12-24 @ 4:23 PM
NCT ID:
NCT02099266
Eligibility Criteria:
Inclusion Criteria:
* Voluntary written informed consent
* Subjects must be \>/= 17 yrs and \</= 70 yrs for non-myeloablative transplant
* Subjects must be \>/= 17 yrs and \</= 55 yrs for myeloablative transplant
* Subjects with Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS), Hodgkin's Lymphoma (HL) and Non-Hodgkin's Lymphoma (NHL) who are considered for UCB transplant
* Use of approved form of contraception
* Karnofsky performance status of \>/= 70%
* Adequate hepatic, renal, pulmonary and cardiac function. Criteria include:
* ALT (alanine aminotransferase), AST (aspartate aminotransferase: \< 4x IULN (institutional upper limit of normal)
* Total bilirubin \</= 2 mg/dL
* Serum creatinine \< 2.0 mg/dL
* Left ventricular ejection fraction \>/= 45%
* FEV1 (forced expiratory volume), FVC (forced vital capacity) and DLCD (diffusing capacity of lung for carbon monoxide) \>/= 50% of predicted value (corrected to serum hemoglobin)
Exclusion Criteria:
* Pregnancy or breast feeding
* Severe chronic obstructive pulmonary disease requiring oxygen supplementation
* History of spontaneous pneumothorax
* History of seizures
* Claustrophobia
* Asthma
* Uncontrolled viral or bacterial infection at the time of enrollment
* Active or recent (prior 6 months) invasive fungal infection without interdisciplinary consult and approval
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
17 Years
Maximum Age:
70 Years
Study:
NCT02099266
Study Brief:
Protocol Section:
NCT02099266