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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT03066466
Eligibility Criteria:
Inclusion Criteria
* Men or women between 18-65 years of age
* Patients designated to undergo allogeneic peripheral blood or bone marrow stem cell transplantation from matched unrelated donor following the diagnosis of one of the following primary diseases in early or intermediate disease status:
* AML at the following stages at time of screening: 1st remission, 2nd remission, and 3rd or subsequent remission
* ALL at the following stages at time of screening: 1st remission, 2nd remission, and 3rd or subsequent remission
* MDS
* Patients must have Performance Score (PS) greater than 70 percent
Exclusion Criteria
* Cardiac: ejection fraction less than 40 percent or other significant cardiac disease
* Pulmonary: FEV1 or DLCO less than 45 percent
* Renal: creatinine greater than the upper limit of normal
* Hepatic: bilirubin greater than 2.0 times the upper limit of normal
* CNS: documented active CNS disease
* Patients who are known to be positive for Hepatitis B surface antigen or Hepatitis C antibody, or who have tested positive for HIV
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03066466
Study Brief:
Protocol Section:
NCT03066466