Phase 2
N=20
Relapse Prophylaxis With N-803 for AML and MDS Pts Following Allo HSCT
Acute Myelogenous Leukemia (AML) · Myelodysplastic Syndrome (MDS)
Bottom Line
View on ClinicalTrials.gov: NCT02989844 ↗Enrolled (actual)
20
Serious AEs
35.0%
Results posted
Nov 2023
Primary outcome: Primary: Incidence of Relapse — 30 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- N-803 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masonic Cancer Center, University of Minnesota
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Relapse |
30 | — |
| SECONDARY Incidence of Adverse Events |
567 | — |
| SECONDARY Incidence of Acute Graft-versus-host Disease |
15; 5 | — |
| SECONDARY Incidence of Acute Graft-versus-host Disease |
15; 5 | — |
| SECONDARY Chronic GVHD |
15 | — |
| SECONDARY Minimal Residual Disease (MRD) |
26 | — |
| SECONDARY Overall Survival |
85 | — |
| SECONDARY Non-Relapse Mortality |
5 | — |
| SECONDARY Relapse |
62; 17 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) for whom an allogeneic hematopoietic stem cell transplant using a reduced intensity conditioning is planned or has been performed and patient is prior to day 60 post-transplant.
- Able to begin study treatment between day +42 and day +60 after the transplant and meets the following transplant related requirements:
- Sustained neutrophil (ANC > 1000/mcL) and platelet (> 30,000/mcL) engraftment
- >50% donor myeloid and lymphoid chimerism blood or bone marrow on most recent bone marrow (BM) evaluation
- No evidence of recurrent disease on most recent bone marrow evaluation (day 21 or 28 post-transplant is acceptable)
- No morphologic evidence of relapse ( 500 milliseconds)
- Active uncontrolled bacterial, fungal, or viral infections - all prior infections must have resolved following optimal therapy and must be afebrile for at least 24 hours at time of enrollment.
- Active autoimmune disease requiring immunosuppressive therapy (GVHD prophylaxis is permitted per institutional practice)
- History of severe asthma and currently on chronic medications (mild asthma requiring inhaled steroids only is eligible)
- Received any investigational agent within the 14 days before the start of study treatment (1st dose of N-803)
Data sourced from ClinicalTrials.gov (NCT02989844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.