Natural Killer (NK) Cell Transplantation for AML
Acute Myeloid Leukemia
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Leukemia, Myeloid, Acute
Eligibility Criteria
Inclusion Criteria: Participants with AML that is in complete remission, is relapsed or refractory, or with increasing minimal residual disease. Participants in complete remission must have recovered from toxicity of previous therapy and have evidence of bone marrow recovery Participants who had prior stem cell transplant (SCT) must have no evidence of GVHD and 60 or more days have elapsed since the SCT. Exclusion Criteria: Participants who are pregnant Participants with inadequate renal, liver, or pulmonary functions
Sites / Locations
- St. Jude Children's Research Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Stratum 1
Stratum 2
Stratum 1 (AML in complete remission) Cyclophosphamide 60 mg/kg IV Day -7 Fludarabine 25 mg/m2/day IV Days -6 through -2 Donor pheresis Day -1 Start IL-2 on Day -1, then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0
Stratum 2 (AML that is refractory or relapsed or AML with increasing minimal residual disease) Clofarabine 40 mg/m2 IV, days -6 through -2 Etoposide 100 mg/m2 IV, days -6 through -2 Cyclophosphamide 400 mg/m2 IV, days -6 through 02 Donor pheresis Day -1 Start IL-2 Day -1, and then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0.