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 @ 3:18 PM
Ignite Modification Date:
2025-12-24 @ 3:18 PM
NCT ID:
NCT02472392
Eligibility Criteria:
Inclusion Criteria:
1. Patients aged 0-30 years with relapsed or therapy refractory ES, excluding patients with brain metastases. Patients who have received a prior autologous stem cell transplant are eligible.
2. Related and unrelated marrow and peripheral blood stem donors must be 9/10 or 10/10 (HLA A, B, C, DR, DQ) matched with the recipient
Exclusion Criteria:
1. Organ dysfunction: Patients who have the following levels of organ system dysfunction are not eligible:
* Cardiac: Ejection Fraction \< 50 %
* Renal: Est. Creatinine Clearance \< 50\*
* Hepatic: Bilirubin \> 3.0
* Pulmonary: DLCO \< 70 %, or for patient who cannot cooperate with pulmonary function testing, O2 saturation \< 95 % on room air.
* Performance status: Lansky performance \< 70; ECOG status \> 2 \*this is based on the Schwartz formula for children less than 18 years of age, and the Cockcroft - Gault formula, for those \> 18 years.\[21, 22\]
2. Patients with an isolated local recurrence of their tumor (in the site of the primary tumor) \> 1 year after completing therapy are excluded, as these patients could be cured with local therapy alone.
3 As a part of the standard of care for pre-transplant evaluation, subjects will be tested for exposure to viral agents such as hepatitis B, C, HTLV-1/2, and HIV. Subjects testing positive for HIV may be rejected as candidates for transplantation, based on the clinical judgment of the stem cell transplant physician
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
30 Years
Study:
NCT02472392
Study Brief:
Protocol Section:
NCT02472392