Cytokine Induced Memory-like NK Cell Adoptive Therapy for... | NCT03068819

ID	Type	Description	Link
P50CA171963	U.S. NIH Grant/Contract		View source

Name	Class
National Cancer Institute (NCI)	NIH
Wugen, Inc.	INDUSTRY
Children's Discovery Institute	OTHER

Label	Type	Description	Intervention Names
CIML NK cell after T cell DLI (Pilot Pediatric/Young Adult Cohort)	Experimental	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.	Drug: CIML NK Cell Infusion Procedure: CD3+ T Cell Product Infusion Procedure: Leukapheresis
CIML NK cell after T cell DLI (Phase 2 Adult Cohort)	Experimental	Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated. A 2nd cycle of therapy may be administered > 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.	Drug: CIML NK Cell Infusion Procedure: CD3+ T Cell Product Infusion Procedure: Leukapheresis
Donors	Other

Name	Type	Description	Arm Group Labels	Other Names
CIML NK Cell Infusion	Drug	Day 0 and possible second cycle > 30 days after the first course	CIML NK cell after T cell DLI (Phase 2 Adult Cohort) CIML NK cell after T cell DLI (Pilot Pediatric/Young Adult Cohort)

Measure	Description	Time Frame
Feasibility of Successfully Generating CIML NK Cells With Standard of Care (SOC) DLI From the Original Stem Cell Donor as Measured by the Number of Participants That Had Successful Doses Infused (Pilot Pediatric/Young Adult Cohort)	-Feasibility is defined as the ability to generate and successfully infuse CIML NK cells with SOC donor lymphocyte infusion (DLI). Will be considered successful if doses above the minimum can be delivered in at least 18 of 24 patients. Target and minimum CIML doses are maximum capped at 20x10^6/kg with a minimum dose of 0.5x10^6 kg.	Completion of all recipients through Day 0
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Unexpected Early Mortality (Pilot Pediatric/Young Adult Cohort)	Unexpected early mortality is defined as deaths that occur through day 100 that are possibly, probably, or definitely related to the study treatment.	Up to Day 100
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Unacceptable Graft Versus Host Disease (GVHD) (Pilot Pediatric/Young Adult Cohort)	Unacceptable GVHD is defined as grade IV acute GVHD as assessed by the Minnesota Grading Scale or grade D acute GVHD as assessed by the CIBMTR Grading Scale.	From day 14 through month 6
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Prolonged Neutropenia (Pilot Pediatric/Young Adult Cohort)	Prolonged neutropenia is defined as an absolute neutrophil count <500/μL persisting for > 2 weeks.	8 weeks post CIML NK infusion
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Unexpected Early Mortality (Phase 2 Adult Cohort)

Measure	Description	Time Frame
Complete Remission Rate (CR/CRi) (Pilot Pediatric/Young Adult Cohort)	Complete remission (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 recover (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.

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

PubMed Identifier	Type	Citation	Retractions
34871371	Derived	Bednarski JJ, Zimmerman C, Berrien-Elliott MM, Foltz JA, Becker-Hapak M, Neal CC, Foster M, Schappe T, McClain E, Pence PP, Desai S, Kersting-Schadek S, Wong P, Russler-Germain DA, Fisk B, Lie WR, Eisele J, Hyde S, Bhatt ST, Griffith OL, Griffith M, Petti AA, Cashen AF, Fehniger TA. Donor memory-like NK cells persist and induce remissions in pediatric patients with relapsed AML after transplant. Blood. 2022 Mar 17;139(11):1670-1683. doi: 10.1182/blood.2021013972.

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

ID	Title	Description
FG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.

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	Apr 16, 2025

ID	Title	Description
BG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
BG001	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)	Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated. A 2nd cycle of therapy may be administered > 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
BG002	Donors	On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00019 BG00115 BG00228 BG00362

Type

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Description

Population Description

Reporting Status

Anticipated Posting Date

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Dispersion Type

Unit of Measure

Calculate Percentage

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Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Feasibility of Successfully Generating CIML NK Cells With Standard of Care (SOC) DLI From the Original Stem Cell Donor as Measured by the Number of Participants That Had Successful Doses Infused (Pilot Pediatric/Young Adult Cohort)

-Feasibility is defined as the ability to generate and successfully infuse CIML NK cells with SOC donor lymphocyte infusion (DLI). Will be considered successful if doses above the minimum can be delivered in at least 18 of 24 patients. Target and minimum CIML doses are maximum capped at 20x10^6/kg with a minimum dose of 0.5x10^6 kg.

Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only. One recipient was removed due to disease progression prior to infusion of CIML NK cells with SOC DLI.

Posted

Count of Participants

Participants

Completion of all recipients through Day 0

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
OG001	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)	Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated. A 2nd cycle of therapy may be administered > 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
OG002	Donors	On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.

Units	Counts
Participants	OG00018 OG0010 OG0020

Title

Denominators

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Title	Measurements
	OG00018

Primary

Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Unexpected Early Mortality (Pilot Pediatric/Young Adult Cohort)

Unexpected early mortality is defined as deaths that occur through day 100 that are possibly, probably, or definitely related to the study treatment.

Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only. One recipient was removed due to disease progression prior to infusion of CIML NK cells with SOC DLI.

Posted

Count of Participants

Participants

Up to Day 100

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
OG001	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)	Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated. A 2nd cycle of therapy may be administered > 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.

Primary

Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Unacceptable Graft Versus Host Disease (GVHD) (Pilot Pediatric/Young Adult Cohort)

Unacceptable GVHD is defined as grade IV acute GVHD as assessed by the Minnesota Grading Scale or grade D acute GVHD as assessed by the CIBMTR Grading Scale.

Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only. One recipient was removed due to disease progression prior to infusion of CIML NK cells with SOC DLI.

Posted

Count of Participants

Participants

From day 14 through month 6

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
OG001	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)	Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated. A 2nd cycle of therapy may be administered > 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.

Primary

Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Prolonged Neutropenia (Pilot Pediatric/Young Adult Cohort)

Prolonged neutropenia is defined as an absolute neutrophil count <500/μL persisting for > 2 weeks.

Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only. One recipient was removed due to disease progression prior to infusion of CIML NK cells with SOC DLI.

Posted

Count of Participants

Participants

8 weeks post CIML NK infusion

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
OG001	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)	Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated. A 2nd cycle of therapy may be administered > 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.

Primary

Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Unexpected Early Mortality (Phase 2 Adult Cohort)

Unexpected early mortality is defined as deaths that occur through day 100 that are possibly, probably, or definitely related to the study treatment.

Evaluability for outcome measure is for Phase 2 Adult Cohort only. One recipient withdrew prior to infusion of CIML NK cells with SOC DLI.

Posted

Count of Participants

Participants

Up to Day 100

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
OG001	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)	Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated. A 2nd cycle of therapy may be administered > 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.

Primary

Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Unacceptable GVHD (Phase 2 Adult Cohort)

Unacceptable GVHD is defined as grade IV acute GVHD as assessed by the Minnesota Grading Scale or grade D acute GVHD as assessed by the CIBMTR Grading Scale.

Evaluability for outcome measure is for Phase 2 Adult Cohort only. One recipient withdrew prior to infusion of CIML NK cells with SOC DLI.

Posted

Count of Participants

Participants

From day 14 through month 6

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
OG001	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)	Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated. A 2nd cycle of therapy may be administered > 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.

Primary

Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Prolonged Neutropenia (Phase 2 Adult Cohort)

Prolonged neutropenia is defined as an absolute neutrophil count <500/μL persisting for > 2 weeks.

Evaluability for outcome measure is for Phase 2 Adult Cohort only. One recipient withdrew prior to infusion of CIML NK cells with SOC DLI.

Posted

Count of Participants

Participants

8 weeks post CIML NK infusion

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
OG001	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)	Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated. A 2nd cycle of therapy may be administered > 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.

Primary

Kaplan-Meier Estimate of Percentage of Participants With Leukemia-Free Survival (LFS) (Phase 2 Adult Cohort)

-LFS is defined as the time from achievement of CR/CRi to the time of relapse, death in remission, or last follow-up.

Evaluability for outcome measure is for Phase 2 Adult Cohort only and only includes those who achieved CR/CRi.

Posted

Number

95% Confidence Interval

percentage of participants-Kaplan Meier

6 months

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)	Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated. A 2nd cycle of therapy may be administered > 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.

Units	Counts

Secondary

Complete Remission Rate (CR/CRi) (Pilot Pediatric/Young Adult Cohort)

Complete remission (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 recover (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.

Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only. One recipient was removed due to disease progression prior to infusion of CIML NK cells with SOC DLI.

Posted

Count of Participants

Participants

Day 30

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.

Secondary

Complete Remission Rate (CR/CRi) (Phase 2 Adult Cohort)

Complete remission (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 recover (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.

Evaluability for outcome measure is for Phase 2 Adult Cohort only. One recipient withdrew prior to infusion of CIML NK cells with SOC DLI.

Posted

Count of Participants

Participants

Day 30

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)	Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated. A 2nd cycle of therapy may be administered > 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.

Secondary

Kaplan-Meier Estimate of Percentage of Participants With Leukemia-Free Survival (LFS) (Pilot Pediatric/Young Adult Cohort)

-LFS is defined as the time from achievement of CR/CRi to the time of relapse, death in remission, or last follow-up.

Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only and only includes those who achieved CR/CRi.

Posted

Number

95% Confidence Interval

percentage of participants-Kaplan Meier

100 days post CIML NK cell infusion

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.

Units	Counts
Participants

Secondary

Kaplan-Meier Estimate of Percentage of Participants With Leukemia-Free Survival (LFS) (Pilot Pediatric/Young Adult Cohort)

-LFS is defined as the time from achievement of CR/CRi to the time of relapse, death in remission, or last follow-up.

Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only and only includes those who achieved CR/CRi.

Posted

Number

95% Confidence Interval

percentage of participants-Kaplan Meier

1 year post CIML NK cell infusion

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.

Units	Counts
Participants

Secondary

Kaplan-Meier Estimate of Percentage of Participants With Leukemia-Free Survival (LFS) (Phase 2 Adult Cohort)

-LFS is defined as the time from achievement of CR/CRi to the time of relapse, death in remission, or last follow-up.

Evaluability for outcome measure is for Phase 2 Adult Cohort only and only includes those who achieved CR/CRi.

Posted

Number

95% Confidence Interval

percentage of participants-Kaplan Meier

100 days post CIML NK cell infusion

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)	Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated. A 2nd cycle of therapy may be administered > 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.

Units	Counts

Secondary

Kaplan-Meier Estimate of Percentage of Participants With Leukemia-Free Survival (LFS) (Phase 2 Adult Cohort)

-LFS is defined as the time from achievement of CR/CRi to the time of relapse, death in remission, or last follow-up.

Evaluability for outcome measure is for Phase 2 Adult Cohort only and only includes those who achieved CR/CRi.

Posted

Median

95% Confidence Interval

percentage of participants-Kaplan Meier

1 year post CIML NK cell infusion

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)	Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated. A 2nd cycle of therapy may be administered > 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.

Units	Counts

Secondary

Kaplan-Meier Estimate of Percentage of Participants With Overall Survival (OS) (Pilot Pediatric/Young Adult Cohort)

-OS is defined as the time from the date of Day 0 until death from any cause.

Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only. One recipient was removed due to disease progression prior to infusion of CIML NK cells with SOC DLI.

Posted

Number

95% Confidence Interval

percentage of participants-Kaplan Meier

100 days post CIML NK cell infusion

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.

Units	Counts
Participants

Secondary

Kaplan-Meier Estimate of Percentage of Participants With Overall Survival (OS) (Pilot Pediatric/Young Adult Cohort)

-OS is defined as the time from the date of Day 0 until death from any cause.

Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only. One recipient was removed due to disease progression prior to infusion of CIML NK cells with SOC DLI.

Posted

Number

95% Confidence Interval

percentage of participants-Kaplan Meier

1 year post CIML NK cell infusion

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.

Units	Counts
Participants

Secondary

Kaplan-Meier Estimate of Percentage of Participants With Overall Survival (OS) (Phase 2 Adult Cohort)

-OS is defined as the time from the date of Day 0 until death from any cause.

Evaluability for outcome measure is for Phase 2 Adult Cohort only. One recipient withdrew prior to infusion of CIML NK cells with SOC DLI.

Posted

Number

95% Confidence Interval

percentage of participants-Kaplan Meier

100 days post CIML NK cell infusion

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)	Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated. A 2nd cycle of therapy may be administered > 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.

Units	Counts

Secondary

Kaplan-Meier Estimate of Percentage of Participants With Overall Survival (OS) (Phase 2 Adult Cohort)

-OS is defined as the time from the date of Day 0 until death from any cause.

Evaluability for outcome measure is for Phase 2 Adult Cohort only. One recipient withdrew prior to infusion of CIML NK cells with SOC DLI.

Posted

Number

95% Confidence Interval

percentage of participants-Kaplan Meier

1 year post CIML NK cell infusion

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)	Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated. A 2nd cycle of therapy may be administered > 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.

Units	Counts

Secondary

Incidence and Severity of Acute GVHD Rates as Assessed on the Minnesota Grading Scale (Pilot Pediatric/Young Adult Cohort)

Incidence and severity of acute GVHD will be assessed based on the Minnesota grading scale. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).
The Minnesota Grading scale is graded with I, II, III, IV. Grade I is the least severe and Grade IV is the most severe.

Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only. One recipient was removed due to disease progression prior to infusion of CIML NK cells with SOC DLI.

Posted

Count of Participants

Participants

Day 14 through 6 months

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
OG001	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)

Secondary

Incidence and Severity of Acute GVHD Rates as Assessed on the CIBMTR Grading Scale (Pilot Pediatric/Young Adult Cohort)

Incidence and severity of acute GVHD will be assessed based on the CIBMTR grading scale. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).
The CIBMTR grading scale is graded with A, B, C, or D. Grade A is considered the least severe with Grade D being the most severe.

Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only. One recipient was removed due to disease progression prior to infusion of CIML NK cells with SOC DLI.

Posted

Count of Participants

Participants

Day 14 through 6 months

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
OG001	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)

Secondary

Incidence and Severity of Chronic GVHD Rates (Pilot Pediatric/Young Adult Cohort)

Incidence and severity of chronic GVHD will be assessed based on the NIH consensus criteria and global severity scoring system. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).
Severity is graded with mild, moderate, or severe chronic GVHD.

Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only. One recipient was removed due to disease progression prior to infusion of CIML NK cells with SOC DLI. 8 recipients were not evaluable as they were removed prior to any chronic GVHD assessments.

Posted

Count of Participants

Participants

Day 100 through 12 months

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
OG001	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)

Secondary

Incidence and Severity of Acute GVHD Rates as Assessed on the Minnesota Grading Scale (Phase 2 Adult Cohort)

Incidence and severity of acute GVHD will be assessed based on the CIBMTR grading scale. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).
The Minnesota Grading scale is graded with I, II, III, IV. Grade I is the least severe and Grade IV is the most severe.

Evaluability for outcome measure is for Phase 2 Adult Cohort only. One recipient withdrew prior to infusion of CIML NK cells with SOC DLI.

Posted

Count of Participants

Participants

Day 14 through 6 months

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
OG001	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)	Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated. A 2nd cycle of therapy may be administered > 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.

Secondary

Incidence and Severity of Acute GVHD Rates as Assessed on the CIBMTR Grading Scale (Phase 2 Adult Cohort)

Incidence and severity of acute GVHD will be assessed based on the CIBMTR grading scale. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).
The CIBMTR grading scale is graded with A, B, C, or D. Grade A is considered the least severe with Grade D being the most severe.

Evaluability for outcome measure is for Phase 2 Adult Cohort only. One recipient withdrew prior to infusion of CIML NK cells with SOC DLI.

Posted

Count of Participants

Participants

Day 14 through 6 months

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
OG001	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)	Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated. A 2nd cycle of therapy may be administered > 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.

Secondary

Incidence and Severity of Chronic GVHD Rates (Phase 2 Adult Cohort)

Incidence and severity of chronic GVHD will be assessed based on the NIH consensus criteria and global severity scoring system. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).
Severity is graded with mild, moderate, or severe chronic GVHD.

Evaluability for outcome measure is for Phase 2 Adult Cohort only. One recipient withdrew prior to infusion of CIML NK cells with SOC DLI. 12 recipients were not evaluable as they were removed prior to any chronic GVHD assessments.

Posted

Count of Participants

Participants

Day 100 through 12 months

ID	Title	Description
OG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
OG001	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG00011 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Eosinophilia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Febrile neutropenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Hemolysis	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Dilated coronary arteries	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Dilated left ventricle	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Pericardial effusion	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Sinus bradycardia	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected19 at risk EG0013 affected15 at risk EG00228 at risk
Sinus tachycardia	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected19 at risk EG0019 affected15 at risk EG00228 at risk
Mastoid effusion	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Adrenal insufficiency	Endocrine disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Cushingoid	Endocrine disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Blurred vision	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Dry eye	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Subconjunctival hemorrhage	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Abdominal distension	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Abdominal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Anal fistula	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Anal mucositis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Anal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Ascites	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Bleeding gums	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Bloating	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Cheilitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Colitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Constipation	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected19 at risk EG0017 affected15 at risk EG00228 at risk
Diarrhea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected19 at risk EG0017 affected15 at risk EG00228 at risk
Dry mouth	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Dyspepsia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Enterocolitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Fecal incontinence	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Flatulence	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Frequent solid bowel movements	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Gagging	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Gastritis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Gingival pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Gingival swelling	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Hematemesis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Hemorrhoidal hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Hemorrhoids	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Ileus	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Jaw pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Mouth sore	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Mucositis oral	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected19 at risk EG0014 affected15 at risk EG00228 at risk
Nausea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected19 at risk EG0016 affected15 at risk EG00228 at risk
Oral hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Oral lesion	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Oral pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Oral plaque	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Periodontal disease	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Small intestinal mucositis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Stomach pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Upper gastrointestinal hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Vomiting	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected19 at risk EG0013 affected15 at risk EG00228 at risk
Chills	General disorders	CTCAE (4.0)	Systematic Assessment	EG00011 affected19 at risk EG00111 affected15 at risk EG00228 at risk
Diffuse pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Edema face	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Edema limbs	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG00111 affected15 at risk EG00228 at risk
Facial pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Fatigue	General disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected19 at risk EG00110 affected15 at risk EG00228 at risk
Fever	General disorders	CTCAE (4.0)	Systematic Assessment	EG00011 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Flu like symptoms	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Fluid overload	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Gait disturbance	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Infusion related reaction	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Injection site reaction	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0014 affected15 at risk EG00228 at risk
Irritability	General disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Localized edema	General disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Malaise	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0013 affected15 at risk EG00228 at risk
Non-cardiac chest pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0013 affected15 at risk EG00228 at risk
Oroantral fistula	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Overdose of controlled substance	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected19 at risk EG0013 affected15 at risk EG00228 at risk
Post sedation sickness	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Hepatomegaly	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Cytokine release syndrome	Immune system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Bacteremia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Bacteremia - Staphylococcus epidermidis (MRSE)	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
C-difficile colitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
C. difficile	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
CMV infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Candida krusel fungal	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
E. Faecium bacteremia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Enterocolitis infectious	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Epstein-Barr virus	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Lung infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0013 affected15 at risk EG00228 at risk
MRSE + blood bacteremia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Oral thrush	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Parainfluenza	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Salivary gland infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Sinusitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Skin infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Upper respiratory infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Bruising	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0005 affected19 at risk EG0015 affected15 at risk EG00228 at risk
Fall	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0015 affected15 at risk EG00228 at risk
Activated partial thromboplastin time prolonged	Investigations	CTCAE (4.0)	Systematic Assessment	EG0003 affected19 at risk EG0014 affected15 at risk EG00228 at risk
Alanine aminotransferase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0009 affected19 at risk EG0017 affected15 at risk EG00228 at risk
Alkaline phosphatase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0003 affected19 at risk EG0017 affected15 at risk EG00228 at risk
Aspartate aminotransferase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0009 affected19 at risk EG0018 affected15 at risk EG00228 at risk
Blood bilirubin increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0004 affected19 at risk EG0017 affected15 at risk EG00228 at risk
Cardiac troponin I increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Creatinine increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0014 affected15 at risk EG00228 at risk
Electrocardiogram QT corrected interval prolonged	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0014 affected15 at risk EG00228 at risk
Fibrinogen decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
GGT increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0008 affected19 at risk EG0010 affected15 at risk EG00228 at risk
INR increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0014 affected15 at risk EG00228 at risk
Lipase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Lymphocyte count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 affected19 at risk EG0013 affected15 at risk EG00228 at risk
Lymphocyte count increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Neutrophil count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Platelet count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0006 affected19 at risk EG0013 affected15 at risk EG00228 at risk
Weight loss	Investigations	CTCAE (4.0)	Systematic Assessment	EG0003 affected19 at risk EG0012 affected15 at risk EG00228 at risk
White blood cell decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Anorexia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected19 at risk EG00111 affected15 at risk EG00228 at risk
Dehydration	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Hypercalcemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Hyperglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Hyperkalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected19 at risk EG0017 affected15 at risk EG00228 at risk
Hypermagnesemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Hypernatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected19 at risk EG0013 affected15 at risk EG00228 at risk
Hyperuricemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected19 at risk EG0014 affected15 at risk EG00228 at risk
Hypocalcemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Hypoglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Hypokalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00010 affected19 at risk EG00110 affected15 at risk EG00228 at risk
Hypomagnesemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected19 at risk EG0013 affected15 at risk EG00228 at risk
Hyponatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0009 affected19 at risk EG0016 affected15 at risk EG00228 at risk
Hypophosphatemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected19 at risk EG0015 affected15 at risk EG00228 at risk
Iron overload	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Ankle instability	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Arthritis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Back pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected19 at risk EG0015 affected15 at risk EG00228 at risk
Bone infarct	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Flank pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected19 at risk EG0014 affected15 at risk EG00228 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Myalgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Myositis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Neck pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Altered mental status	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Concentration impairment	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Dizziness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0016 affected15 at risk EG00228 at risk
Dysarthria	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Dysgeusia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Encephalopathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Facial muscle weakness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Headache	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected19 at risk EG0015 affected15 at risk EG00228 at risk
Hypersomnia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Insomnia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0013 affected15 at risk EG00228 at risk
Lethargy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Movements involuntary	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Paresthesia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Peripheral motor neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Peripheral sensory neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Syncope	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Tremor	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Agitation	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Anxiety	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0013 affected15 at risk EG00228 at risk
Confusion	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Delirium	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Depression	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Hallucinations	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Acute kidney injury	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Burn with urination	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Dysuria	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Enlarged kidneys	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Hematuria	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected19 at risk EG0017 affected15 at risk EG00228 at risk
Incomplete urination	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Proteinuria	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0014 affected15 at risk EG00228 at risk
Urinary frequency	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0013 affected15 at risk EG00228 at risk
Urinary incontinence	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0013 affected15 at risk EG00228 at risk
Urinary retention	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Urinary tract obstruction	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Urine discoloration	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Mennorhagia	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Pelvic pain	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected19 at risk EG0014 affected15 at risk EG00228 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0016 affected15 at risk EG00228 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0016 affected15 at risk EG00228 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected19 at risk EG0016 affected15 at risk EG00228 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected19 at risk EG0014 affected15 at risk EG00228 at risk
Sleep apnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Sore throat	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Tachypnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0012 affected15 at risk EG00228 at risk
Transfusion associated circulatory overload	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0013 affected15 at risk EG00228 at risk
Alopecia	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Bullous dermatitis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Diaper dermatitis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Dry skin	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Erosion/scratch	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Erythema	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Erythema at G tube site	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0013 affected15 at risk EG00228 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Lesion on arm	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Periorbital edema	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Petechiae	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Pruritus	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Purpura	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected19 at risk EG0015 affected15 at risk EG00228 at risk
Red lump	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Scaling of scalp	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected15 at risk EG00228 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0013 affected15 at risk EG00228 at risk
Hematoma	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected19 at risk EG0011 affected15 at risk EG00228 at risk
Hypertension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected19 at risk EG0019 affected15 at risk EG00228 at risk
Hypotension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected19 at risk EG0017 affected15 at risk EG00228 at risk
Kawasaki Disease	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected19 at risk EG0010 affected15 at risk EG00228 at risk

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

ID	Term
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

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)	Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.	14	19	5	19	19	19
EG001	CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)	Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated. A 2nd cycle of therapy may be administered > 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.	14	15	10	15	15	15
EG002	Donors	On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.	0	28	0	28	0	28