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 @ 1:09 AM
Ignite Modification Date:
2025-12-25 @ 1:09 AM
NCT ID:
NCT03384693
Eligibility Criteria:
Inclusion Criteria
1. Age 0-30 years of age
2. Life expectancy \> 6 months
3. Eastern Cooperative Oncology Group or Karnofsky Performance Status \>40
4. Meets minimum organ function requirements per institutional standard of care guiding clearance for autologous or allogeneic stem cell transplantation.
5. Patients must meet TMA High-Risk criteria 5A or 5B below:
5A. Patients undergoing tandem autologous transplant with thiotepa in one or more of the conditioning regimens
OR:
5B. . Patients with at least 3 of the following characteristics:
1. \>10 years of age
2. Non-Caucasian race/ Hispanic ethnicity
3. Undergoing haploidentical transplant
4. Minor ABO blood group mismatch
Exclusion Criteria:
1. Age \>30 years
2. Life expectancy \< 6 months
3. Known bleeding diathesis or bleeding risk deemed by the treating physician to be a contraindication to administration of anticoagulants.
4. Known hypersensitivity reaction to defibrotide
5. Any patient not meeting TMA High-Risk criteria
6. Pregnant women are excluded from this study because they will be receiving teratogenic therapy as part of the stem cell transplant.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
30 Years
Study:
NCT03384693
Study Brief:
Protocol Section:
NCT03384693