| Inclusion Criteria: | 1) Recipient Inclusion criteria (within 28 days of this protocol's lymphodepleting conditioning regimen and after donor and recipient consent-signing)
2) Diagnosis of CD22+ acute lymphoblastic leukemia that is a. refractory to therapy or b. in second or greater relapse without other standard therapeutic options.
3) Patient may have been the recipient of an allogeneic hematopoietic stem cell transplant; however; there must be no evidence of GVHD.
4) Off prednisone or other immunosuppressive medications for at least 3 days prior to both the lymphodepleting regimen and the NK infusion.
5) Zubrod performance scale </= 2 or Lansky performance scale >/= 60.
6) Adequate renal function defined as: Serum creatinine (Cr), for adults </= 2 mg/dL, for children </= 2 mg/dL or </= 2 times upper limit of normal (ULN) for age (whichever is less). If abnormal renal function, then Cr clearance >/= 60 mL/min/1.73 m^2.
7) Adequate liver function defined as: Total bilirubin </= 2 mg/dL and SGPT (ALT) </= 5 x ULN for age (unless Gilbert's disease or abnormal liver function due to primary disease).
8) Pulmonary symptoms controlled by medication and pulse oximetry >/= 92% room air.
9) Negative serum test to rule out pregnancy within 2 weeks prior to registration in females of childbearing potential (non childbearing is defined as greater than one year post-menopausal or surgically sterilized).
10) Requirement of sexually active females and males to use any form of contraception considered effective and medically acceptable by the Investigator. [Acceptable forms: birth control implants, birth control pills, a vasectomy (male surgical sterilization), or a double-barrier method (any 2 of the following in combination: IUD, male or female condom with spermicidal gel, a diaphragm, a sponge, and/or cervical cap)]
11) Negative serology for human immunodeficiency virus (HIV).
12) Donor must be related to recipient and is predicted to be alloreactive based upon the presence of the relevant KIR genes and incompatibility with the recipient for HLA C or Bw antigens.
13) Donor must have infectious disease marker testing [Hepatitis B, C, HIV, CMV, Syphilis (RPR), Chagas, HTLV, and West Nile Virus] and CBC differential and platelet studies that meet standard medical eligibility criteria for allogeneic blood stem cell donation within 7 days of apheresis.
14) Donor, if a female of childbearing potential (non-childbearing is defined as greater than one year post-menopause or surgically sterilized), must have a negative serum test to rule out pregnancy within 14 days of apheresis.
15) Donor must meet standard medical eligibility criteria for allogeneic stem cell donation. |