Cytokine-induced Memory-like NK Cells in Patients With Ac... | NCT01898793

NCT01898793

ID	Type	Description	Link
5F32CA200253-02	U.S. NIH Grant/Contract		View source

Status Module

Sponsor/Collaborators Module

Name	Class
American Society of Clinical Oncology	OTHER
American Society of Hematology	OTHER
Gabrielle's Angel Foundation	OTHER
The Leukemia and Lymphoma Society

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK cells	Experimental	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)	Drug: Fludarabine Drug: Cyclophosphamide Procedure: Leukapheresis Biological: Cytokine-induced killer cells Biological: IL-2 Procedure: Peripheral blood for correlative studies Procedure: Bone marrow for correlative studies
Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK cells	Experimental	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)	Drug: Fludarabine Drug: Cyclophosphamide Procedure: Leukapheresis Biological: Cytokine-induced killer cells Biological: IL-2 Procedure: Peripheral blood for correlative studies Procedure: Bone marrow for correlative studies
Phase I Dose Level 3: Maximum NK cell/number kg	Experimental	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fludarabine	Drug		Lead-in Cohort & Phase II (ALT-803): Maximum NK cell/number kg Pediatric Cohort: Maximum NK cell/number kg Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK cells Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK cells

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximal Tolerated or Tested Dose (MT/TD) of CIML-NK Cells (Phase I)	Defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity (DLT) or the maximum dose if less than or equal to 1 patient suffers a DLT at the maximum dose.	35 days
Complete Remission Rate (CR/CRi) in Participants With Relapsed or Refractory AML Following CIML NK Therapy (Phase II)	Complete remission rate (CR): Morphologically leukemia free state (i.e. bone marrow with <5% blasts by morphologic criteria and no blasts with Auer rods, no evidence of extramedullary leukemia) and absolute neutrophil count ≥1000 /μL and platelets ≥100,000 /μL. Patient must be independent of transfusions Complete Remission with Incomplete Blood Count Recovery (CRi): All of the above criteria for CR must be met, except that absolute neutrophils <1000 /μL or platelets <100,000 /μL in the blood.	Up to 3 years
Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort)	Graded using the National Cancer (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Related indicates possibly, probably, or definitely related to study treatment. Adverse events will be collected from Day 0 to Day +35; however, bone marrow suppression (ANC < 500/uL/µL) and AEs of GVHD involving the liver, skin, or GI tract will be recorded to Day 100.	Through Day 100

Secondary Outcomes

Measure	Description	Time Frame
Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric)		35 days
Duration of Remission (DOR) (Phase I, Phase II, and Pediatric)	DOR is defined only for patients who achieve a complete remission (CR), complete remission with incomplete blood count recovery (CRi), marrow complete response (mCR), or partial remission (PR), and is measured from the first date of attaining CR or PR until the date of disease progression or death.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis requirement for phase I patients:
- Refractory AML without complete remission (CR) after induction therapy (primary induction failure) or relapsed AML after obtaining a CR.
- OR High-risk AML (by ELN criteria; See Appendix C) in complete remission (CR) and has either refused hematopoietic stem cell transplantation OR is currently not eligible for hematopoietic stem cell transplantation OR for whom hematopoietic stem cell transplantation is being reserved for later relapse. This is inclusive of patients with minimal residual disease evidenced by cytogenetics, molecular testing, and/or flow cytometry.
- OR Myelodysplastic syndrome (MDS) with excess blasts (>5%) and progressive disease at any time after initiation of DNA hypomethylator treatment during the past 2 years, OR failure to achieve complete or partial response or hematological improvement (see section 12.4) after at least six cycles of azacytidine or four cycles of decitabine administered during the past 2 years, OR intolerance to azacytidine or decitabine. MDS patients with isolated 5q- abnormalities that meet these criteria after lenalidomide therapy and DNA hypomethylator therapy are also eligible.
Diagnosis requirement for phase II patients:

*Refractory AML without CR after induction therapy (primary induction failure) or relapsed AML after obtaining a CR. Favorable-risk core binding factor (CBF) mutated AML and acute promyelocytic leukemia (APL) will be excluded.
Diagnosis requirement for pediatric cohort patients:

*Refractory AML without complete remission (CR) after induction therapy (primary induction failure) or relapsed AML after obtaining a CR.
Age requirement for phase I and phase II patients: At least 18 years of age.
Age requirement for pediatric cohort: 2-17 years of age.
Available HLA-haploidentical donor that meets the following criteria:
- Related donor (parent, sibling, offspring, or offspring of sibling)
- At least 18 years of age
- HLA-haploidentical donor/recipient match by at least Class I serologic typing at the A&B locus.
- In general good health, and medically able to tolerate leukapheresis required for harvesting the NK cells for this study.
- Negative for hepatitis, HTLV, and HIV on donor viral screen
- Not pregnant
- Voluntary written consent to participate in this study
Patients with known CNS involvement with AML are eligible provided that they have been treated and CSF is clear for at least 2 weeks prior to enrollment into the study. CNS therapy (chemotherapy or radiation) should continue as medically indicated during the study treatment.
Karnofsky/Lansky performance status ≥ 50 %
Adequate organ function as defined below:
- Total bilirubin ≤ 2 mg/dL
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- Creatinine within normal institutional limits OR creatinine clearance ≥ 50 mL/min/1.73 m2 by Cockcroft-Gault Formula (adults) or Schwartz formula (pediatric cohort)
- Oxygen saturation ≥90% on room air
- Ejection fraction ≥35%
Able to be off corticosteroids and any other immune suppressive medications beginning on Day -3 and continuing until 30 days after the infusion of the CIML NK cells. However, use of low-level corticosteroids is permitted if deemed medically necessary. Low-level corticosteroid use is defined as 10mg or less of prednisone (or equivalent for other steroids) per day.
Women of childbearing potential must have a negative pregnancy test within 28 days prior to study registration. Female and male patients (along with their female partners) must agree to use two forms of acceptable contraception, including one barrier method, during participation in the study and throughout the DLT evaluation period.
Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

Relapsed after allogeneic transplantation.
Isolated extramedullary relapse (phase II only).
More than one course of salvage chemotherapy for primary induction failure or AML relapsing after CR1 (phase II only).
Circulating blast count ≥30,000/µL by morphology or flow cytometry (cytoreductive therapies including leukapheresis or hydroxyurea are allowed).
Uncontrolled bacterial or viral infections, or known HIV, Hepatitis B or C infection.
Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or EKG suggestive of acute ischemia or active conduction system abnormalities.
New progressive pulmonary infiltrates on screening chest x-ray or chest CT scan that have not been evaluated with bronchoscopy. Infiltrates attributed to infection must be stable/ improving after 1 week of appropriate therapy (4 weeks for presumed or proven fungal infections).
Known hypersensitivity to one or more of the study agents.
Received any investigational drugs within the 14 days prior to the first dose of fludarabine.
Pregnant and/or breastfeeding.

Contacts/Locations Module

Name	Affiliation	Role
Amanda Cashen, M.D.	Washington University School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Washington University School of Medicine		St Louis	Missouri	63110	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19181844	Background	Cooper MA, Elliott JM, Keyel PA, Yang L, Carrero JA, Yokoyama WM. Cytokine-induced memory-like natural killer cells. Proc Natl Acad Sci U S A. 2009 Feb 10;106(6):1915-9. doi: 10.1073/pnas.0813192106. Epub 2009 Jan 30.
22983442	Background	Romee R, Schneider SE, Leong JW, Chase JM, Keppel CR, Sullivan RP, Cooper MA, Fehniger TA. Cytokine activation induces human memory-like NK cells. Blood. 2012 Dec 6;120(24):4751-60. doi: 10.1182/blood-2012-04-419283. Epub 2012 Sep 14.

Label	URL
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 11, 2020

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Phase I Dose Level 3: Maximum NK cell/number kg

Phase II (IL-2): Maximum NK cell/number kg

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)
BG001	Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)
BG002	Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)
BG003	Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors on Day -1. CIML NK Cells: Patients undergo CIML NK cell infusion on Day 0. Subcutaneous ALT-803 will begin approximately 4 hours after the infusion and will continue for a total of 2 doses (Days 0 and 5).
BG004	Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells	The recipient will begin a lymphodepleting preparative regimen of fludarabine and cyclophosphamide on Day -6. The haploidentical donor identified by HLA matching of the immediate family members will undergo non-mobilized large volume (20-L) leukapheresis on Day -1, and the NK cell product will be infused into the recipient on Day 0. Subcutaneous IL-2 will begin approximately 2-4 hours after infusion and will continue every other day through Day 12 for a total of 7 doses.
BG005	Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors on Day -1 CIML NK Cells: Patients undergo CIML NK cell infusion on Day 0 Subcutaneous IL-2 will begin approximately 2-4 hours after infusion and will continue every other day through Day 12 for a total of 7 doses
BG006	Donors	-The haploidentical donor identified by HLA matching of the immediate family members (parents, siblings, and children) will undergo non-mobilized leukapheresis on Day -1. Peripheral blood mononuclear cells (PBMCs) will be collected using standard collection techniques.
BG007	Total	Total of all reporting groups

Units	Counts
Participants	BG0005 BG0015 BG0029 BG0038 BG0049 BG0058 BG00645 BG00789

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00076(70 to 77) BG00172(51 to 76) BG00271(43 to 83) BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001 BG0012 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG0005 BG0015 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Maximal Tolerated or Tested Dose (MT/TD) of CIML-NK Cells (Phase I)

Defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity (DLT) or the maximum dose if less than or equal to 1 patient suffers a DLT at the maximum dose.

Posted

Number

x 10^7 cells/kg

35 days

ID	Title	Description
OG000	Phase I	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)

Units	Counts
Participants	OG00019

Title

Denominators

Categories

Title	Measurements
	OG0001.0

Primary

Complete Remission Rate (CR/CRi) in Participants With Relapsed or Refractory AML Following CIML NK Therapy (Phase II)

Complete remission rate (CR): Morphologically leukemia free state (i.e. bone marrow with <5% blasts by morphologic criteria and no blasts with Auer rods, no evidence of extramedullary leukemia) and absolute neutrophil count ≥1000 /μL and platelets ≥100,000 /μL. Patient must be independent of transfusions
Complete Remission with Incomplete Blood Count Recovery (CRi): All of the above criteria for CR must be met, except that absolute neutrophils <1000 /μL or platelets <100,000 /μL in the blood.

Posted

Count of Participants

Participants

Up to 3 years

ID	Title	Description
OG000	Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors on Day -1. CIML NK Cells: Patients undergo CIML NK cell infusion on Day 0. Subcutaneous ALT-803 will begin approximately 4 hours after the infusion and will continue for a total of 2 doses (Days 0 and 5).
OG001	Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells	The recipient will begin a lymphodepleting preparative regimen of fludarabine and cyclophosphamide on Day -6. The haploidentical donor identified by HLA matching of the immediate family members will undergo non-mobilized large volume (20-L) leukapheresis on Day -1, and the NK cell product will be infused into the recipient on Day 0. Subcutaneous IL-2 will begin approximately 2-4 hours after infusion and will continue every other day through Day 12 for a total of 7 doses.

Primary

Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort)

Graded using the National Cancer (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Related indicates possibly, probably, or definitely related to study treatment.
Adverse events will be collected from Day 0 to Day +35; however, bone marrow suppression (ANC < 500/uL/µL) and AEs of GVHD involving the liver, skin, or GI tract will be recorded to Day 100.

Posted

Count of Participants

Participants

Through Day 100

ID	Title	Description
OG000	Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors on Day -1 CIML NK Cells: Patients undergo CIML NK cell infusion on Day 0 Subcutaneous IL-2 will begin approximately 2-4 hours after infusion and will continue every other day through Day 12 for a total of 7 doses

Units	Counts
Participants	OG000

Secondary

Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric)

Posted

Count of Participants

Participants

35 days

ID	Title	Description
OG000	Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)
OG001	Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)
OG002	Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)

Secondary

Duration of Remission (DOR) (Phase I, Phase II, and Pediatric)

DOR is defined only for patients who achieve a complete remission (CR), complete remission with incomplete blood count recovery (CRi), marrow complete response (mCR), or partial remission (PR), and is measured from the first date of attaining CR or PR until the date of disease progression or death.

Only for patients who achieve a complete remission (CR), complete remission with incomplete blood count recovery (CRi), marrow complete response (mCR), or partial remission (PR).

Posted

Median

Full Range

days

Up to 3 years

ID	Title	Description
OG000	Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)
OG001	Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)

Secondary

Time to Progression (Phase I, Phase II, and Pediatric)

TTP is defined as the time from date of first dose of fludarabine until evidence of disease progression.

Not evaluable: 2 patients Phase 1 Dose Level 1 (didn't receive adequate cell dose, expired before infusion). 2 patients Phase I Dose Level 2 (expired before infusion, received haplo transplant before PD). 3 patients Phase I Dose Level 3 (no bone marrow biopsy, 2-expired before PD). 2 patients Phase II IL-2 (2-no bone marrow biopsy). 1 patient Phase II ALT-803 (expired before response assessment). 2 patients Pediatric (expired before PD, poor bone marrow sample).

Posted

Median

Full Range

days

Up to 3 years

ID	Title	Description
OG000	Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)
OG001	Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)

Secondary

Disease Free Survival (DFS) (Phase I, Phase II, and Pediatric)

DFS is defined as the time from the day CR, mCR, or CRi is documented until disease progression or death.

Only those patients with CR, mCR, or CRi are evaluable for this outcome measure.

Posted

Median

95% Confidence Interval

days

Up to 3 years

ID	Title	Description
OG000	Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)
OG001	Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)

Secondary

Overall Survival (OS) (Phase I, Phase II, and Pediatric)

OS is defined from the date of first dose of fludarabine on this study until death.

Posted

Median

95% Confidence Interval

days

Up to 3 years

ID	Title	Description
OG000	Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)
OG001	Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)
OG002	Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells

Secondary

Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II)

Graded using the National Cancer (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Related indicates possibly, probably, or definitely related to study treatment.
AEs will be collected from Day 0 to Day +35; however, bone marrow suppression (ANC < 500/uL/µL) and AEs of GVHD involving the liver, skin, or GI tract will be recorded to Day 100.

Posted

Count of Participants

Participants

Through Day 100

ID	Title	Description
OG000	Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)
OG001	Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)	5	5	2	5	4	4
EG001	Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK Cells	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)	4	5	0	5	5	5
EG002	Phase I Dose Level 3: Maximum NK Cell/Number kg	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)	8	9	2	9	9	9
EG003	Lead-in Cohort & Phase II (ALT-803): Maximum NK Cell/Number kg	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors on Day -1. CIML NK Cells: Patients undergo CIML NK cell infusion on Day 0. Subcutaneous ALT-803 will begin approximately 4 hours after the infusion and will continue for a total of 2 doses (Days 0 and 5).	8	8	4	8	8	8
EG004	Phase II (IL-2): Maximum NK Cell/Number kg	The recipient will begin a lymphodepleting preparative regimen of fludarabine and cyclophosphamide on Day -6. The haploidentical donor identified by HLA matching of the immediate family members will undergo non-mobilized large volume (20-L) leukapheresis on Day -1, and the NK cell product will be infused into the recipient on Day 0. Subcutaneous IL-2 will begin approximately 2-4 hours after infusion and will continue every other day through Day 12 for a total of 7 doses.	9	9	4	9	9	9
EG005	Pediatric Cohort: Maximum NK Cell/Number kg	Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors on Day -1 CIML NK Cells: Patients undergo CIML NK cell infusion on Day 0 Subcutaneous IL-2 will begin approximately 2-4 hours after infusion and will continue every other day through Day 12 for a total of 7 doses	8	8	0	8	8	8
EG006	Donors	-The haploidentical donor identified by HLA matching of the immediate family members (parents, siblings, and children) will undergo non-mobilized leukapheresis on Day -1. Peripheral blood mononuclear cells (PBMCs) will be collected using standard collection techniques.	0	0	0	0	0	0

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Multi-organ failure	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG0030 affected8 at risk EG0040 affected9 at risk EG0050 affected8 at risk EG0060 at risk
Sepsis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Muscle weakness lower limb	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Death due to acute myeloid leukemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Encephalopathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Cardiopulmonary arrest	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0023 affected9 at risk EG0030 affected8 at risk EG0041 affected9 at risk EG0052 affected8 at risk EG0060 at risk
Febrile neutropenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected4 at risk EG0015 affected5 at risk EG0026 affected9 at risk EG003
Hemolysis	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Atrial fibrillation	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0022 affected9 at risk EG003
Atrial flutter	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Heart failure	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Left ventricular systolic dysfunction	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
NSTEMI	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Right ventricular dysfunction	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Sinus bradycardia	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Sinus tachycardia	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Supraventricular tachycardia	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Impacted cerumen	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Tinnitus	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Double vision	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Ptosis	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Retinal hemorrhage	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Abdominal distension	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Abdominal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected4 at risk EG0011 affected5 at risk EG0021 affected9 at risk EG003
Anal ulcer	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Constipation	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0011 affected5 at risk EG0022 affected9 at risk EG003
Diarrhea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Dysphagia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Epigastric pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Fecal incontinence	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Gastroesophageal reflux disease	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Hemorrhoids	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Ileus	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Lip pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Lower gastrointestinal hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Mucositis oral	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected4 at risk EG0012 affected5 at risk EG0025 affected9 at risk EG003
Nausea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected4 at risk EG0012 affected5 at risk EG0024 affected9 at risk EG003
Oral hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Oral pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Oral ulcer	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Pancreatitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Proctitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Tongue ulceration	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Vomiting	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0011 affected5 at risk EG0022 affected9 at risk EG003
Axilla pain/swelling	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Body aches	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Burning at femoral area	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
CVC site tender	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Chills	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected4 at risk EG0012 affected5 at risk EG0025 affected9 at risk EG003
Diffuse body aches	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Edema face	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Edema limbs	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected4 at risk EG0012 affected5 at risk EG0025 affected9 at risk EG003
Fatigue	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0013 affected5 at risk EG0023 affected9 at risk EG003
Fever	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Gait disturbance	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Infusion related reaction	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Injection site reaction	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Irritability	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Localized edema	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Malaise	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected4 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Rigors	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0024 affected9 at risk EG003
Rigors after IL-2 administration	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Gallstones	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Hyperammonemia	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Allergic reaction	Immune system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Cytokine release syndrome	Immune system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Angioinvasive fungus	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Bacteremia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Bacteremia-Rothia mucilaginosa	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Candidemia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
E. faecium in stool	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Folliculitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
HHV-6	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Influenza AH3	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Lung infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Oral thrush	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Paronychia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Rhinitis infective	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Sepsis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0012 affected5 at risk EG0021 affected9 at risk EG003
Sinusitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Skin infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0012 affected5 at risk EG0023 affected9 at risk EG003
Sphingomonas in blood	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Urinary tract infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0021 affected9 at risk EG003
VRE enterococcus species, stool bacteremia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Vaginal infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Bleeding from trifusion site	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Bruising	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0021 affected9 at risk EG003
Fall	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Foley catheter pain	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Pain at bone marrow biopsy site	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Scalp hematoma post fall	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Subarachnoid hemorrhage post fall	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Tenderness at bone marrow biopsy site	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Activated partial thromboplastin time prolonged	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 affected4 at risk EG0011 affected5 at risk EG0022 affected9 at risk EG003
Alanine aminotransferase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0003 affected4 at risk EG0012 affected5 at risk EG0024 affected9 at risk EG003
Alkaline phosphatase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0013 affected5 at risk EG0023 affected9 at risk EG003
Aspartate aminotransferase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 affected4 at risk EG0011 affected5 at risk EG0024 affected9 at risk EG003
Blood bilirubin increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0011 affected5 at risk EG0022 affected9 at risk EG003
Cardiac troponin I increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Creatinine increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Electrocardiogram QT corrected interval prolonged	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
INR increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 affected4 at risk EG0012 affected5 at risk EG0025 affected9 at risk EG003
Lymphocyte count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Neutrophil count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0022 affected9 at risk EG003
Platelet count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 affected4 at risk EG0012 affected5 at risk EG0023 affected9 at risk EG003
Weight gain	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Weight loss	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0023 affected9 at risk EG003
White blood cell decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0022 affected9 at risk EG003
Acidosis	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Alkalosis	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Anorexia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0011 affected5 at risk EG0023 affected9 at risk EG003
Dehydration	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Hyperglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0022 affected9 at risk EG003
Hyperkalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0011 affected5 at risk EG0022 affected9 at risk EG003
Hypermagnesemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0021 affected9 at risk EG003
Hypernatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0012 affected5 at risk EG0022 affected9 at risk EG003
Hypertriglyceridemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Hyperuricemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Hypoalbuminemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected4 at risk EG0012 affected5 at risk EG0023 affected9 at risk EG003
Hypocalcemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0012 affected5 at risk EG0023 affected9 at risk EG003
Hypoglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0022 affected9 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected4 at risk EG0012 affected5 at risk EG0024 affected9 at risk EG003
Hypomagnesemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0011 affected5 at risk EG0021 affected9 at risk EG003
Hyponatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected4 at risk EG0011 affected5 at risk EG0024 affected9 at risk EG003
Hypophosphatemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0012 affected5 at risk EG0027 affected9 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Buttock pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Facial muscle weakness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Generalized aches and pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected4 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Muscle tension left side of head	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0021 affected9 at risk EG003
Right posterior knee knot	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Disease progression of central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Neuroendocrine tumor	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Decreased motor function	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Depressed level of consciousness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Dizziness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0021 affected9 at risk EG003
Dysgeusia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Encephalopathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0022 affected9 at risk EG003
Headache	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0022 affected9 at risk EG003
Intracranial hemorrhage	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Lethargy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Paresthesia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Sinus pain	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Somnolence	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0023 affected9 at risk EG003
Stroke	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Tremor	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Worsening blepharospasm	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Anxiety	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Confusion	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0022 affected9 at risk EG003
Delirium	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Insomnia	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Restlessness	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Acute kidney injury	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Burning with urination	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Cystitis noninfective	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Dysuria	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Hematuria	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0012 affected5 at risk EG0023 affected9 at risk EG003
Proteinuria	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0012 affected5 at risk EG0023 affected9 at risk EG003
Urinary frequency	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Urinary incontinence	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Urinary retention	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Urinary urgency	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Paraphimosis	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Penile bloody discharge	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Penile pain	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0012 affected5 at risk EG0023 affected9 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0011 affected5 at risk EG0021 affected9 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Hoarseness	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0011 affected5 at risk EG0025 affected9 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0022 affected9 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Possible aspiration	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Pulmonary alveolar hemorrhage/DAH	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0022 affected9 at risk EG003
Pulmonary nodule	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0011 affected5 at risk EG0022 affected9 at risk EG003
Tachypnea-intermittent	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Abrasion	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0022 affected9 at risk EG003
Blister of left great toe	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Erythema around central line	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Leukemia cutis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Periorbital edema	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0023 affected9 at risk EG003
Skin breakdown	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Skin induration	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Skin lesions	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Skin ulceration	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Capillary leak syndrome	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Flushing	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Hematoma	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Hypertension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected5 at risk EG0022 affected9 at risk EG003
Hypotension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0013 affected5 at risk EG0023 affected9 at risk EG003
Lymphedema	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Subdural hematoma	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Superficial thrombophlebitis	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Thromboembolic event	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003

ID	Term
D015470	Leukemia, Myeloid, Acute

ID	Term
C024352	fludarabine
C042382	fludarabine phosphate
D003520	Cyclophosphamide
D007937	Leukapheresis
D007376	Interleukin-2
C082598	aldesleukin
D007378	Interleukins
C582303	ALT-803

Ancestor Terms

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D009930	Organic Chemicals
D063088	Phosphoramides
D009943	Organophosphorus Compounds
D016238	Cytapheresis
D001691	Biological Therapy
D013812	Therapeutics
D001781	Blood Component Removal
D047589	Leukocyte Reduction Procedures
D002469	Cell Separation
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D008919	Investigative Techniques
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D008222	Lymphokines
D011506	Proteins
D001685	Biological Factors

EG0041 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0043 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0047 affected9 at risk

EG0052 affected8 at risk

EG0040 affected9 at risk

EG0051 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0042 affected9 at risk

EG0050 affected8 at risk

EG0041 affected9 at risk

EG0050 affected8 at risk

EG0041 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0051 affected8 at risk

EG0041 affected9 at risk

EG0053 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0041 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0041 affected9 at risk

EG0050 affected8 at risk

EG0041 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0051 affected8 at risk

EG0041 affected9 at risk

EG0050 affected8 at risk

EG0041 affected9 at risk

EG0052 affected8 at risk

EG0040 affected9 at risk

EG0051 affected8 at risk

EG0043 affected9 at risk

EG0052 affected8 at risk

EG0046 affected9 at risk

EG0052 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0041 affected9 at risk

EG0050 affected8 at risk

EG0041 affected9 at risk

EG0050 affected8 at risk

EG0041 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0051 affected8 at risk

EG0041 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0045 affected9 at risk

EG0050 affected8 at risk

EG0044 affected9 at risk

EG0051 affected8 at risk

EG0040 affected9 at risk

EG0051 affected8 at risk

EG0040 affected9 at risk

EG0051 affected8 at risk

EG0041 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0045 affected9 at risk

EG0052 affected8 at risk

EG0041 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0051 affected8 at risk

EG0041 affected9 at risk

EG0050 affected8 at risk

EG0041 affected9 at risk

EG0050 affected8 at risk

EG0044 affected9 at risk

EG0056 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0041 affected9 at risk

EG0050 affected8 at risk

EG0043 affected9 at risk

EG0052 affected8 at risk

EG0047 affected9 at risk

EG0052 affected8 at risk

EG0042 affected9 at risk

EG0054 affected8 at risk

EG0041 affected9 at risk

EG0050 affected8 at risk

EG0045 affected9 at risk

EG0050 affected8 at risk

EG0042 affected9 at risk

EG0052 affected8 at risk

EG0042 affected9 at risk

EG0050 affected8 at risk

EG0041 affected9 at risk

EG0050 affected8 at risk

EG0043 affected9 at risk

EG0051 affected8 at risk

EG0042 affected9 at risk

EG0056 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0051 affected8 at risk

EG0041 affected9 at risk

EG0051 affected8 at risk

EG0044 affected9 at risk

EG0050 affected8 at risk

EG0041 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

EG0041 affected9 at risk

EG0050 affected8 at risk

EG0040 affected9 at risk

EG0050 affected8 at risk

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases