Last reviewed · How we verify
MT2014-25: Haplo NK With SQ IL-15 in Adult Relapsed or Refractory AML Patients
Phase 2 trial testing IL-15 in Acute Myelogenous Leukemia in 17 participants. Completed in 1 December 2016.
| 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 | 17 |
| Start date | 1 October 2015 |
| Primary completion | 1 December 2016 |
| Estimated completion | 1 December 2016 |
| Sites | 1 location across United States |
Masonic Cancer Center, University of Minnesota
Adults 18 to 70, any sex, with Acute Myelogenous Leukemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Without platelet recovery
| Group | Value | 95% CI |
|---|---|---|
| Preparative Regimen and SubQ rHuIL-15 | 5 |
| Group | Value | 95% CI |
|---|---|---|
| Preparative Regimen and SubQ rHuIL-15 | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Preparative Regimen and SubQ rHuIL-15 | 10 |
| Group | Value | 95% CI |
|---|---|---|
| Preparative Regimen and SubQ rHuIL-15 | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Preparative Regimen and SubQ rHuIL-15 | 1 |
Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Preparative Regimen and Su… |
|---|---|---|
| Cytokine Release Syndrome - Grade 3 | Immune system disorders | — |
| Cytokine Release Syndrome - Grade 4 | Immune system disorders | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Abdominal Infection | Infections and infestations | — |
| Endocarditis Infective | Infections and infestations | — |
| Hepatitis Viral | Infections and infestations | — |
| Infections and Infestations - Other, specify | Infections and infestations | — |
| Lung Infection | Infections and infestations | — |
| Sepsis | Infections and infestations | — |
| Sinusitis | Infections and infestations | — |
| Muscle Weakness Lower Limb | Musculoskeletal and connective tissue disorders | — |
| Intracranial Hemorrhage | Nervous system disorders | — |
| Seizure | Nervous system disorders | — |
| Acute Kidney Injury | Renal and urinary disorders | — |
| Adult Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | — |
| Hypotension | Vascular disorders | — |
| Reaction | System | Preparative Regimen and Su… |
|---|---|---|
| Cytokine release syndrome | Immune system disorders | — |
| Weight gain | Investigations | — |
| Confusion | Psychiatric disorders | — |
| Headache | Nervous system disorders | — |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Encephalopathy | Nervous system disorders | — |
| Fatigue | General disorders | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Hypotension | Vascular disorders | — |
| Periorbital edema | Skin and subcutaneous tissue disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Blood bilirubin increased | Investigations | — |
| Chest wall pain | Musculoskeletal and connective tissue disorders | — |
| Creatinine increased | Investigations | — |
| Flu like symptoms | General disorders | — |
| Gait disturbance | General disorders | — |
| Hiccups | Respiratory, thoracic and mediastinal disorders | — |
| Hypernatremia | Metabolism and nutrition disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Infections and infestations - Other, specify | Infections and infestations | — |
| Intracranial hemorrhage | Nervous system disorders | — |
| Nervous system disorders - Other, specify | Nervous system disorders | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Seizure | Nervous system disorders | — |
| Sepsis | Infections and infestations | — |
| Sinusitis | Infections and infestations | — |
| Mouth/tongue sores | General disorders | — |
| Non Convulsive Status Epilipticus | Nervous system disorders | — |
Most-reported serious reactions: Cytokine Release Syndrome - Grade 3, Cytokine Release Syndrome - Grade 4, Febrile neutropenia, Abdominal Infection, Endocarditis Infective, Hepatitis Viral, Infections and Infestations - Other, specify, Lung Infection.
Data from ClinicalTrials.gov NCT02395822 adverse events section.
A phase II trial of CD3/CD19 depleted, IL-15 activated, donor natural killer (NK) cells in adults and subcutaneous IL-15 given after a preparative regimen for the treatment of relapsed or refractory acute myelogenous leukemia (AML). The primary objective is to study the potential efficacy of NK cells and IL-15 to achieve complete remission while maintaining safety.
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02395822.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing