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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT03123133
Eligibility Criteria:
Inclusion Criteria:
1. Male and female patients age 2 or older.
2. Weigh at least 13kg (30lbs), and in the opinion of the investigator, are healthy enough to participate in study activities.
3. Evidence of a personally signed and dated informed consent/assent document indicating that the subject or a legally acceptable representative (parent(s)/legal guardian) has been informed of all pertinent aspects of the study.
4. Diseases treated with HSCT, including malignant and nonmalignant diseases.
5. Planned fractionated total body irradiation (TBI) as part of clinical care with a cumulative dose ≥6 Gy or a single dose between 1.5 and 3.0 Gy.
Exclusion Criteria:
1. Subjects who have received chemotherapy within 21 days prior to TBI.
2. Concurrent chemotherapy with Fludarabine or an investigational product
3. Cytokine inhibitor or cytokine-inducer therapy within 30 days prior to and during the irradiation regimen
4. Subjects who have received GCSF within 30 days prior to TBI
5. Participants, who in the opinion of the investigator, may not be able to comply with the requirements of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT03123133
Study Brief:
Protocol Section:
NCT03123133