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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT02512718
Eligibility Criteria:
Inclusion:
1. Planned myeloablative allogeneic bone marrow, cord, or peripheral blood stem cell (from any donor, including haploidentical donor) HCT conditioning regimen using either TBI (planned cumulative dose \>1100cGy) or busulfan in addition to other chemotherapeutic agents
2. Planned related or unrelated bone marrow donor matched at a minimum of out of 10 human leukocyte antigen (HLA) loci (HLA-A, -B, -C, -DRB1, and -DQ), or planned related or unrelated cord blood donor matched at a minimum of 4 out of 6 HLA loci (HLA-A, -B, and -DRB1), or a haplo- identical related donor; typing must be at the allele level for unrelated donors, antigen level typing is acceptable for related donors
3. Diagnosis of a hematological malignancy including myelodysplasia.
Exclusion:
1. Unable or unwilling to return for day +30 or day +100 testing
2. GVHD prophylaxis that includes rapamycin
3. Allergy to egg, fish (including seafood and/or shellfish), or soy/legume products
a. Patients with egg, fish (including seafood and/or shellfish), or soy/legume intolerance without a documented allergy may still be included at the discretion of the PI and patient/family
4. Other contraindication to PN or intravenous lipids
5. Unstable diabetes mellitus
6. Stroke, cardiac infarction or embolism within 6 months prior to HCT OR current, ongoing treatment for stroke, infarction, and/or embolism
7. Undefined coma status,
8. Lipid nephrosis,
9. Pathological hyperlipidemia (2 consecutive fasting triglyceride levels \> 500 mg/dL),
10. Active/acute pancreatitis with hyperlipidemia (fasting triglyceride levels \> 500 mg/dL) (see section 3.5 for specific diagnostic criteria),
11. History of parenteral nutrition (PN) use with any intravenous lipid product or use of any intravenous lipid product without PN within 6 months prior to HCT
12. Co-enrollment in other interventional clinical studies.
13. Clinically significant pleural or pericardial effusion
a) If a pleural or pericardial effusion is noted on the pre-transplant testing echocardiogram, the PI will contact the cardiologist to ask if it is clinically significant. If clinically insignificant pleural or pericardial effusion exists at baseline AND the patient is randomized to FOLE, the PI will seek approval for inclusion with the primary attending and decide upon appropriate monitoring to include close clinical observation, cardiology consultation and/or serial echocardiograms where appropriate.
14. Aluminum toxicity, especially in patients with renal impairment
15. Risk of infection
16. Refeeding syndrome
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
18 Years
Study:
NCT02512718
Study Brief:
Protocol Section:
NCT02512718