A Randomized Trial Comparing CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploidentical Donor Natural Killer (NK) Cell Based Therapy in Older Adults With Acute Myelogenous Leukemia in First Complete Remission
The trial will use a single-stage design and will take place in two parts. The first part
will support the selection of the better NK cell product as measured by in vivo NK cell
expansion. Successful in vivo NK cell expansion is defined as 40% donor DNA and 40% of
lymphocytes are NK cells at day 7 post infusion OR 20% donor DNA and 20% of lymphocytes are
NK cells at day 14 post infusion.
Part 1: 1:1 randomization with 10 patients per cohort to either:
1. CD3-/CD19- NK cell product or
2. CD3-/CD56+ purified NK cell product The product with better NK cell expansion will be
used for the rest of the trial. If the results and safety profile are equivalent, the
CD56+ selection approach will be used. If neither approach results in successful NK
cell expansion, the trial will be stopped and the platform redesigned.
Part 2: complete the trial by enrolling an additional 26 patients using the product deemed
successful during part 1 to estimate the primary endpoint (DFS at 12 months)
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
the length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works.
Jeffrey S. Miller, M.D.
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|Masonic Cancer Center, University of Minnesota||Minneapolis, Minnesota 55455|