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 @ 9:47 PM
Ignite Modification Date:
2025-12-24 @ 9:47 PM
NCT ID:
NCT02386332
Eligibility Criteria:
Inclusion Criteria:
1. Age: subjects ≥ 18 and ≤ 55 years old.
2. Patients without suitable matched related donor
3. Diagnosed with acute leukemia or myelodysplastic syndrome in which allogeneic transplantation is considered the most potentially curative therapeutic option.
4. Written consent form signed.
Exclusion Criteria:
* Performance status: Eastern Cooperative Oncology Group(ECOG) score \>2
* Prior allogenic hematopoietic stem cell transplant
* Left-ventricular ejection fraction at rest \< 45%, uncontrolled arrhythmias or symptomatic heart failure.
* Diffusing capacity (DLCO) and/or forced vital capacity (FVC) \< 39% of predicted values or symptomatic pulmonary disease
* Altered liver function tests (total bilirubin \> 2 mg/dL and/or alanine aminotransferase, aspartate aminotransferase , and or active hepatitis or cirrhosis.
* Serum creatinine \> 2 mg/dL or estimated creatinine clearance \< 50 mL/min
* Evidence of uncontrolled bacterial, viral or fungal infection prior to the conditioning regimen
* Serious diseases that prevent patients from receiving chemotherapy treatments.
* Concomitant neoplasms.
* Pregnancy or breast-feeding.
* Any other medical, surgical or psychiatric condition that is considered by the attending and/or medical team as a contraindication for intensive treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02386332
Study Brief:
Protocol Section:
NCT02386332