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Relapse Prophylaxis With N-803 for AML and MDS Pts Following Allo HSCT
Phase 2 trial testing N-803 in Acute Myelogenous Leukemia (AML) in 20 participants. Completed in 31 August 2022.
| Lead sponsor | Masonic Cancer Center, University of Minnesota |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 12 April 2017 |
| Primary completion | 19 March 2022 |
| Estimated completion | 31 August 2022 |
| Sites | 1 location across United States |
Masonic Cancer Center, University of Minnesota
18 and older, any sex, with Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS). Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)
| Group | Value | 95% CI |
|---|---|---|
| N-803 | 30 | 12 – 51 |
Frequency of all adverse
| Group | Value | 95% CI |
|---|---|---|
| N-803 | 567 |
Incidence of grade 2-4 and grade 3-4 acute graft-versus-host-disease (GVHD)
| Group | Value | 95% CI |
|---|---|---|
| N-803 | 10 | 2 – 28 |
| Group | Value | 95% CI |
|---|---|---|
| N-803 | 0 | 0 – 100 |
Incidence of grade 2-4 and grade 3-4 acute graft-versus-host-disease (GVHD)
| Group | Value | 95% CI |
|---|---|---|
| N-803 | 15 | 4 – 34 |
| Group | Value | 95% CI |
|---|---|---|
| N-803 | 5 | 0 – 21 |
Incidence of acute graft-versus-host disease
| Group | Value | 95% CI |
|---|---|---|
| N-803 | 15 | 4 – 34 |
Incidence of minimal residual disease (MRD) post-transplant
| Group | Value | 95% CI |
|---|---|---|
| N-803 | 26 | 12 – 49 |
Incidence of overall survival at one year
| Group | Value | 95% CI |
|---|---|---|
| N-803 | 85 | 71 – 99 |
Incidence of non-relapse mortality
| Group | Value | 95% CI |
|---|---|---|
| N-803 | 5 | 0 – 21 |
Incidence of relapse at 2 years after alloHCT stratified by number of doses of N-803 (1-3 or 4-10)
| Group | Value | 95% CI |
|---|---|---|
| N-803 | 62 | 18 – 88 |
| Group | Value | 95% CI |
|---|---|---|
| N-803 | 17 | 2 – 43 |
Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | N-803 |
|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Infections and infestations - Other, | Infections and infestations | — |
| Immune system disorders - Other, | Immune system disorders | — |
| Sepsis | Infections and infestations | — |
| Fall | Injury, poisoning and procedural complications | — |
| Lung infection | Infections and infestations | — |
| Pericardial effusion | Cardiac disorders | — |
| Reaction | System | N-803 |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | — |
| Injection site reaction | General disorders | — |
| Injection site reaction | General disorders | — |
| Neutrophil count decreased | Investigations | — |
| Platelet count decreased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Hypertension | Vascular disorders | — |
| Chills | General disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Fatigue | General disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Headache | Nervous system disorders | — |
| Edema limbs | General disorders | — |
| Fever | General disorders | — |
| Creatinine increased | Investigations | — |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Upper respiratory infection | Infections and infestations | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Hypotension | Vascular disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Lymphocyte count decreased | Investigations | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Gait disturbance | General disorders | — |
| Fall | Injury, poisoning and procedural complications | — |
| Hypermagnesemia | Metabolism and nutrition disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Infections and infestations - Other, specify | Infections and infestations | — |
| Paronychia | Infections and infestations | — |
| Dizziness | Nervous system disorders | — |
| Atrial Fibrillation | Cardiac disorders | — |
| Dry eye | Eye disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Dry mouth | Gastrointestinal disorders | — |
Most-reported serious reactions: Respiratory failure, Atrial fibrillation, Infections and infestations - Other,, Immune system disorders - Other,, Sepsis, Fall, Lung infection, Pericardial effusion.
Data from ClinicalTrials.gov NCT02989844 adverse events section.
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).
8 peer-reviewed publications reference this trial (live from Europe PMC):
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