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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT00529360
Eligibility Criteria:
Inclusion Criteria:
* Age: Patients must be \<30 years of age.
* Disease Status: ALL in relapse, induction failure, CR3, or CR3P (Part A ONLY); AML in relapse, induction failure, CR3, or CR3P (Part A ONLY); ALL in CR3 or CR3P (Part A and Part B); AML in CR3 or CR3P (Part A and BONLY); CR3/CR3P must be documented by bone marrow and CNS assessment within 14 days of initiation of the pre-transplant conditioning regimen.
* Creatinine clearance \>40 ml/min/m2 or \>60 ml/min/1.73 m2 or an equivalent radioisotope glomerular filtration rate (GFR) as determined by the institutional normal range or serum creatinine based on age
* Adequate liver function defined as: Total bilirubin \<2.5 mg/dl l, or SGOT (AST) or SGPT (ALT) \<5 x upper limit of normal
* Adequate cardiac function defined as: Shortening fraction \>27% by echocardiogram, or Ejection fraction of \>50% by radionuclide angiogram or echocardiogram.
* Adequate pulmonary function defined as: Corrected DLCO \>60% by pulmonary function test; For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \>94% on room air.
* Performance Status: For patients age 1-16 years, Lansky score of \>60; For patients \> 16 years, Karnofsky score of \>60.
* Patients must have received a minimum of one round of re-induction and one round of consolidation chemotherapy after relapse #2
Exclusion Criteria:
* Patients with prior myeloablative allogeneic stem cell transplantation and /or TBI.
* Females who are pregnant (positive HCG) or lactating.
* Karnofsky \<60% or Lansky \<60% if less than 16 years of age
* Age \>30 years of age
* Any patient with uncontrolled infection prior to study entry
* Patients with evidence of active disease.
* Patients with Down syndrome are excluded
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
30 Years
Study:
NCT00529360
Study Brief:
Protocol Section:
NCT00529360