Leukemia Clinical Trials

∙ Recipient

• Age less than or equal to 21 years

• High risk hematologic malignancy where allogeneic transplantation is the current standard of care. This includes (but is not limited to):

‣ High risk CD19+ B cell ALL in CR1 or CR2

⁃ Any CD19+ B-cell ALL in CR3 or subsequent

• If prior CNS leukemia, it must be treated and in CNS CR

• Left ventricular ejection fraction \> 40%, or shortening fraction ≥ 25%

• Creatinine clearance (CrCl) or glomerular filtration rate (GFR) ≥ 50 ml/min/1.73m2

• Forced vital capacity (FVC) ≥ 50% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing

• Karnofsky or Lansky (age dependent) performance score ≥ 50 (See APPENDIX A)

• Bilirubin ≤ 3 times the upper limit of normal for age

• Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age

∙ Donor

• At least single haplotype matched (≥ 4 of 8) family member

• At least 18 years of age

• HIV negative

• If sexually active, agreement to use birth control until 2 weeks after completion of the mobilization and apheresis procedure

• Regarding donation eligibility, is identified as either:

‣ Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR

⁃ Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271