This is a single-arm, multi-center Phase II trial using IL-15 super-agonist complex (N-803 formerly known as Alt-803) maintenance after allogeneic hematopoietic cell transplant (alloHCT) for acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
N-803 at 6 mcg/kg SQ Day 1 of a 4 week (28 day) cycle with ± 1 week window Continue N-803 every 4 weeks for 10 doses or until relapse, unacceptable toxicity, or patient refusal, whichever comes earlier.
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Incidence of Relapse
Efficacy of N-803 as measured by the cumulative incidence of relapse between the 1st dose of N-803 and 2 years after a reduced intensity conditioning (RIC) allogeneic hematopoietic cell transplant (alloHCT)
Time frame: 24 months
Incidence of Adverse Events
Frequency of all adverse
Time frame: 12 months
Incidence of Acute Graft-versus-host Disease
Incidence of grade 2-4 and grade 3-4 acute graft-versus-host-disease (GVHD)
Time frame: Day 100
Incidence of Acute Graft-versus-host Disease
Incidence of grade 2-4 and grade 3-4 acute graft-versus-host-disease (GVHD)
Time frame: Day 180
Chronic GVHD
Incidence of acute graft-versus-host disease
Time frame: 1 year
Minimal Residual Disease (MRD)
Incidence of minimal residual disease (MRD) post-transplant
Time frame: 1 year
Overall Survival
Incidence of overall survival at one year
Time frame: 1 year post transplant
Non-Relapse Mortality
Incidence of non-relapse mortality
Time frame: 1 year
Relapse
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Incidence of relapse at 2 years after alloHCT stratified by number of doses of N-803 (1-3 or 4-10)
Time frame: 2 Years