Pilot Study Of Haplo-Identical Natural Killer Cell Transplantation For Acute Myeloid Leukemia
Natural killer (NK) cells extracted from a [parental] donor are infused intravenously. Most
patients are given a multi-agent chemotherapeutic conditioning regimen prior to the
infusion. The conditioning regimen may be omitted for patients who have previously received
traditional stem cell transplant.
Details of Treatment Plan:
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
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.
For patients who have received prior SCT, the conditioning regimen may be omitted if the NK
cells are obtained from the original SCT donor.
Cytokine regimen (stratum 1 and 2): 1 million units/m2 of IL-2 given subcutaneously three
times per week for two weeks (6 doses) starting on the evening of day -1.
NK Cell Transplantation (stratum 1 and 2): NK cells from haplo-identical family donor will
be infused on day 0.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 100 Days Post-transplant
Document the number of patients experiencing grade 3 or 4 toxicities during conditioning and up to 100 days post-transplant. Toxicities were identified using Common Toxicity Criteria V 3.0 criteria.
Beginning at on therapy through 100 days post-transplant
Jeffrey E. Rubnitz, M.D.
St. Jude Children's Resarch Hospital
United States: Food and Drug Administration
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|