This is a standard phase 2 study powered to demonstrate improvement in the 100 day leukemia free survival to 30% from \<10% expected with the use of reduced intensity haplo-HCT in this extremely high-risk patient cohort (based on the institutional experience using non-myeloablative / reduced intensity conditioning in a similar patient cohort). A formal safety evaluation will be done after every 6th patient enrolled and the trial will be stopped if noted to have unusually higher engraftment failure (acute GVHD rates (\>60% any grades or \>30% grade III/IV or ≥ 50% severe cGVHD) or engraftment failure rates (≥15%).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
-Day 0
-GVHD prophylaxis
-GVHD prophylaxis
-Continue until neutrophil engraftment as per institutional guidelines
-Day +7
-Start approximately 4 hours after CIML NK cell infusion
-Day +6
Washington University School of Medicine
St Louis, Missouri, United States
Kaplan-Meier Estimate of Leukemia-free Survival Rate (LFS)
-LFS is defined as the time from achievement of complete remission (CR) to the time of relapse, death in remission, or last follow-up.
Time frame: 1 year post transplantation
Kaplan-Meier Estimate of Leukemia-free Survival Rate (LFS)
-LFS is defined as the time from achievement of CR to the time of relapse, death in remission, or last follow-up.
Time frame: 3 months post transplantation
Kaplan-Meier Estimate of Overall Survival (OS)
-OS is defined as the time from the date of Day 0 until death from any cause.
Time frame: 1 year post transplantation
Number of Recipients With Relapse Who Are Found to be CR (Complete Remission)
-CR: Morphologically leukemia free state (i.e. bone marrow with \<5% blasts by morphologic criteria and no blasts with Auer rods, no evidence of extramedullary leukemia) and absolute neutrophil count ≥1000 /μL and platelets ≥100,000 /μL. Patient must be independent of transfusions.
Time frame: Day 28 post transplantation
Complete Remission (CR) Rate
CR: Morphologically leukemia free state (i.e. bone marrow with \<5% blasts by morphologic criteria and no blasts with Auer rods, no evidence of extramedullary leukemia) and absolute neutrophil count ≥1000 /μL and platelets ≥100,000 /μL. Patient must be independent of transfusions
Time frame: Day 28 post transplantation
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