Trial Outcomes & Findings for Haploidentical Natural Killer Cells to Treat Refractory or Relapsed Acute Myelogenous Leukemia (AML) (NCT NCT01106950)
NCT ID: NCT01106950
Last Updated: 2017-12-28
Results Overview
The primary objective of this study was to estimate the incidence of in vivo expansion of natural killer (NK) cells 14 days after infusion of an allogeneic donor product enriched for NK progenitors. Successful in vivo donor NK cell expansion was defined by measuring an absolute circulating donor-derived NK cell count of \>100 cells/ul in the patient's peripheral blood 14 days after infusion.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Day 14
Results posted on
2017-12-28
Participant Flow
Study entry was open to patients 2 years and older regardless of gender, race, or ethnic background.
Seventeen patients were enrolled, however, 2 patients did not receive Ontak (study drug) and were not included in the analysis.
Participant milestones
| Measure |
Evaluable (Treated) Patients
Patients with acute myeloid leukemia (AML) are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Haploidentical Natural Killer Cells to Treat Refractory or Relapsed Acute Myelogenous Leukemia (AML)
Baseline characteristics by cohort
| Measure |
Evaluable (Treated) Patients
n=15 Participants
Patients are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
|
|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 23.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14The primary objective of this study was to estimate the incidence of in vivo expansion of natural killer (NK) cells 14 days after infusion of an allogeneic donor product enriched for NK progenitors. Successful in vivo donor NK cell expansion was defined by measuring an absolute circulating donor-derived NK cell count of \>100 cells/ul in the patient's peripheral blood 14 days after infusion.
Outcome measures
| Measure |
Evaluable (Treated) Patients
n=15 Participants
Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
|
Evaluable (Treated) Patients (Expansion=Yes)
KIR mismatched: Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
|
|---|---|---|
|
Percent of Patients With Successful Expansion of Natural Killer Cells After Infusion
|
27 Percentage of patients
|
—
|
SECONDARY outcome
Timeframe: At least 4 weeks after last dose (28 days)Disease response was defined as complete remission (disease response) by morphologic criteria including \<5% blasts in a moderately cellular or cellular marrow. Complete remission was also correlated with NK cell expansion in vivo, IL-15 levels and donor/recipient KIR B genotyping, and Treg depletion.
Outcome measures
| Measure |
Evaluable (Treated) Patients
n=15 Participants
Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
|
Evaluable (Treated) Patients (Expansion=Yes)
KIR mismatched: Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
|
|---|---|---|
|
Percent of Patients With Complete Remission of Disease
|
53 Percentage of patients
|
—
|
SECONDARY outcome
Timeframe: Month 6Number of patients alive and disease free at 6 months. The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works.
Outcome measures
| Measure |
Evaluable (Treated) Patients
n=15 Participants
Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
|
Evaluable (Treated) Patients (Expansion=Yes)
KIR mismatched: Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
|
|---|---|---|
|
Percent of Patients With Disease Free Survival
|
33 Percentage of patients
|
—
|
SECONDARY outcome
Timeframe: Month 6Number of patients who have had a relapse(the return of disease after its apparent recovery/cessation) after obtaining a complete remission of their disease.
Outcome measures
| Measure |
Evaluable (Treated) Patients
n=15 Participants
Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
|
Evaluable (Treated) Patients (Expansion=Yes)
KIR mismatched: Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
|
|---|---|---|
|
Percent of Patients With Incidence of Relapse
|
53 Percentage of patients
|
—
|
SECONDARY outcome
Timeframe: Day 100Number of patients who died within the first 100 days of treatment due to toxicity.
Outcome measures
| Measure |
Evaluable (Treated) Patients
n=15 Participants
Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
|
Evaluable (Treated) Patients (Expansion=Yes)
KIR mismatched: Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
|
|---|---|---|
|
Number of Patients With Treatment-Related Death
|
13 Percentage of patients
|
—
|
SECONDARY outcome
Timeframe: Day 14Association between in vivo natural killer (NK) cell expansion and complete response without platelet recovery (CRp) with donor killer immunoglobulin-like (KIR) genotype and Treg depletion. In vivo donor NK cell expansion was correlated with regulatory T-cell (Treg) depletion as detected on flow cytometry.
Outcome measures
| Measure |
Evaluable (Treated) Patients
n=7 Participants
Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
|
Evaluable (Treated) Patients (Expansion=Yes)
n=8 Participants
KIR mismatched: Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
|
|---|---|---|
|
Percent of Patients With Natural Killer Cell Expansion Versus KIR Genotype Versus Treg Depletion
|
43 Percentage of patients
|
13 Percentage of patients
|
Adverse Events
Treated Patients
Serious events: 12 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treated Patients
n=15 participants at risk
Patients with acute myeloid leukemia (AML) are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
20.0%
3/15 • Number of events 3
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Cardiac disorders
Atrial fibrillation
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Blood and lymphatic system disorders
Blood disorder
|
33.3%
5/15 • Number of events 5
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Blood and lymphatic system disorders
Bone marrow hypocellular
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Blood and lymphatic system disorders
Hematologic toxicity - ANC<500
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Skin and subcutaneous tissue disorders
Infusion related reaction
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural hemorrhage
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Gastrointestinal disorders
Typhilitis
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
20.0%
3/15 • Number of events 3
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Infections and infestations
Lung Infection
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Nervous system disorders
Intracranial hemorrhage
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Infections and infestations
Encephalitis infection
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Infections and infestations
Infections and infestations- other
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Infections and infestations
Sepsis
|
13.3%
2/15 • Number of events 2
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
Other adverse events
| Measure |
Treated Patients
n=15 participants at risk
Patients with acute myeloid leukemia (AML) are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury - grade 1
|
13.3%
2/15 • Number of events 2
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Renal and urinary disorders
Acute kidney injury - grade 2
|
13.3%
2/15 • Number of events 2
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Renal and urinary disorders
Acute kidney injury - grade 3
|
13.3%
2/15 • Number of events 2
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse alveolar hemorrhage - grade 5
|
33.3%
5/15 • Number of events 5
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
General disorders
Gum/jaw pain - grade 2
|
26.7%
4/15 • Number of events 5
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Immune system disorders
Autoimmune disorder - grade 1
|
100.0%
15/15 • Number of events 146
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Immune system disorders
Autoimmune disorder - grade 2
|
13.3%
2/15 • Number of events 2
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Immune system disorders
Autoimmune disorder - grade 3
|
60.0%
9/15 • Number of events 12
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Nervous system disorders
Confusion - grade 4
|
6.7%
1/15 • Number of events 2
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Nervous system disorders
Chills - grade 1
|
100.0%
15/15 • Number of events 130
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Nervous system disorders
Chills - grade 2
|
93.3%
14/15 • Number of events 23
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Nervous system disorders
Chills - grade 3
|
86.7%
13/15 • Number of events 28
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - grade 1
|
100.0%
15/15 • Number of events 133
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - grade 2
|
46.7%
7/15 • Number of events 10
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - grade 3
|
46.7%
7/15 • Number of events 15
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - grade 4
|
33.3%
5/15 • Number of events 10
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - grade 5
|
26.7%
4/15 • Number of events 15
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Blood and lymphatic system disorders
Edema - grade 1
|
100.0%
15/15 • Number of events 113
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Blood and lymphatic system disorders
Edema - grade 2
|
60.0%
9/15 • Number of events 36
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Blood and lymphatic system disorders
Edema - grade 3
|
46.7%
7/15 • Number of events 28
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Blood and lymphatic system disorders
Edema - grade 4
|
20.0%
3/15 • Number of events 8
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
General disorders
Headache - grade 1
|
13.3%
2/15 • Number of events 2
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia - grade 1
|
100.0%
15/15 • Number of events 147
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia - grade 3
|
33.3%
5/15 • Number of events 10
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia - grade 4
|
66.7%
10/15 • Number of events 20
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia - grade 5
|
26.7%
4/15 • Number of events 4
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Cardiac disorders
Hypertension - grade 1
|
93.3%
14/15 • Number of events 58
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Cardiac disorders
Hypertension - grade 2
|
60.0%
9/15 • Number of events 42
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Cardiac disorders
Hypertension - grade 3
|
86.7%
13/15 • Number of events 63
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Cardiac disorders
Hypertension - grade 4
|
53.3%
8/15 • Number of events 20
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Cardiac disorders
Hypotension - grade 1
|
100.0%
15/15 • Number of events 142
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Cardiac disorders
Hypotension - grade 2
|
46.7%
7/15 • Number of events 20
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Cardiac disorders
Hypotension - grade 3
|
40.0%
6/15 • Number of events 7
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Cardiac disorders
Hypotension - grade 4
|
26.7%
4/15 • Number of events 12
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Investigations
Infusion related reaction - grade 1
|
100.0%
15/15 • Number of events 156
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Investigations
Infusion related reaction - grade 2
|
20.0%
3/15 • Number of events 4
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Investigations
Infusion related reaction - grade 3
|
26.7%
4/15 • Number of events 4
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
General disorders
Fever - grade 1
|
100.0%
15/15 • Number of events 107
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
General disorders
Fever - grade 2
|
26.7%
4/15 • Number of events 4
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
General disorders
Fever - grade 3
|
20.0%
3/15 • Number of events 5
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
General disorders
Fever - grade 4
|
100.0%
15/15 • Number of events 62
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates - grade 1
|
100.0%
15/15 • Number of events 164
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates - grade 3
|
40.0%
6/15 • Number of events 12
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates - grade 4
|
6.7%
1/15 • Number of events 2
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates - grade 5
|
13.3%
2/15 • Number of events 4
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation - grade 1
|
100.0%
15/15 • Number of events 152
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation - grade 2
|
26.7%
4/15 • Number of events 9
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation - grade 3
|
26.7%
4/15 • Number of events 7
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation - grade 4
|
6.7%
1/15 • Number of events 13
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Gastrointestinal disorders
Abdominal distension - grade 2
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Blood and lymphatic system disorders
Bruising - grade 2
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
General disorders
Chest pain - grade 3
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Blood and lymphatic system disorders
Blood disorder - grade 3
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome - grade 4
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Immune system disorders
Autoimmune disorder - grade 4
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Nervous system disorders
Confusion - grade 3
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Gastrointestinal disorders
Emesis - grade 3
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Cardiac disorders
Heart failure - grade 4
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
General disorders
Headache - grade 2
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
General disorders
Headache - grade 4
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates - grade 2
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Blood and lymphatic system disorders
Febrile neutropenia - grade 3
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Cardiac disorders
Left ventricular systolic dysfunction - grade 3
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis - grade 4
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Vascular disorders
Intracranial hemorrhage - grade 2
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection - grade 4
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Endocrine disorders
Increased creatinine - grade 2
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
|
Endocrine disorders
Increased creatinine - grade 3
|
6.7%
1/15 • Number of events 1
Due to chemotherapy as prep for the NK cell infusion, it is expected that all patients will experience severe depression of their blood counts and other related toxicities. Adverse event (AE) collection will focus on targeted AEs and unexpected AEs at specific time points in relation to the NK cell infusion and IL-2 injections.
|
Additional Information
Jeffrey S. Miller, M.D.
Masonic Cancer Center, University of Minnesota
Phone: 612-625-7409
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place