At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 20 enrolled
Drug / intervention
N-803drug
Likely dose
N-803 6 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Relapse Prophylaxis With IL-15 Super Agonist N-803 in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome Following Reduced Intensity Conditioning (RIC) Allogeneic Stem Cell Transplantation
Masonic Cancer Center, University of Minnesota·interventional·Posted Dec 12, 2016·Updated Nov 3, 2023
In Brief
A Phase 2 clinical trial evaluating N-803 for Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS). Completed, enrolled 20 participants across 1 site.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartApr 2017
Primary CompletionMar 2022
Study CompletionAug 2022
TodayJul 2026
First PostedDec 12, 2016
Enrollment StartApr 12, 2017
Primary CompletionMar 19, 2022
Study CompletionAug 31, 2022
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 9.6 years ago
Interventions
N-803drug
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.