Study of Itacitinib for the Prophylaxis of Graft-Versus-H... | NCT03755414

NCT03755414

ID	Type	Description	Link
K12CA167540	U.S. NIH Grant/Contract		View source

Status Module

Sponsor/Collaborators Module

Name	Class
Incyte Corporation	INDUSTRY
American Society of Hematology	OTHER
National Cancer Institute (NCI)	NIH

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
Pilot Study: Itacitinib	Experimental	Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy Stem cell transplantation on Day 0 Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.	Procedure: Stem cell transplantation Drug: Itacitinib Other: Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) Other: Human Activity Profile
Expansion Phase: Itacitinib	Experimental	Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy Stem cell transplantation on Day 0 Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently	Procedure: Stem cell transplantation Drug: Itacitinib Other: Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) Other: Human Activity Profile
Donors	No Intervention	-Donors were consented for the patients enrolled in the Safety Lead-In Phase (planned 3 patients). Donors were consented for a second CD34+ collection to use as a rescue in the case of engraftment failure and for collection of a research blood specimen prior to mobilization.

Name	Type	Description	Arm Group Labels	Other Names
Stem cell transplantation	Procedure	Standard of care	Expansion Phase: Itacitinib Pilot Study: Itacitinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Graft Failure (Pilot Study Only)	Failure to engraft will be defined as failure to achieve absolute neutrophil count >500 for 3 days by day 35.	By day 35
Number of Participants With Grades III-IV Acute GVHD	-Incidence of acute grade III-IV GVHD will be assessed using Mount Sinai Acute GvHD International Consortium (MAGIC) criteria. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).	Through day 100

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Who Experience Cytokine Release Syndrome (CRS)	The number of participants who experience CRS will be summarized by count of participants who experience Grade 1, 2, 3, 4, & 5 CRS. The worst grade experienced by participant will be noted. Grade 1: symptoms not life threatening & require symptomatic treatment alone, includes fever, nausea, fatigue, malaise Grade 2: symptoms require/respond to limited intervention - oxygen (O2) <40%, <=3 liters (L) nasal cannula or hypotension responsive to fluids or low dose of 1 vasopressor or grade 2 renal or hepatic toxicity Grade 3: symptoms require/respond to aggressive intervention - O2 >=40%, >3L nasal cannula or hypotension requiring high dose or multiple vasopressors or grade 3 renal toxicity or grade 4 transaminitis, new onset altered mental status, new cardiomyopathy without wall motion abnormality Grade 4: life-threatening symptoms - requirement for ventilator support or grade 4 rental toxicity (excluding transaminitis) Grade 5: death

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must meet the following criteria within 30 days prior to Day 0 unless otherwise noted.

Diagnosis of a hematological malignancy listed below:
- Acute myelogenous leukemia (AML) in complete morphological remission (based on International Working Group (IWG) Criteria)
- Acute lymphocytic leukemia (ALL) in complete morphological remission (MRD negative, based on IWG Criteria)
- Myelodysplastic syndrome with ≤ 5% blasts in bone marrow.
- Non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD) in 2nd or greater complete or partial remission.
Planned treatment is myeloablative or reduced intensity conditioning followed by T Cell-replete peripheral blood haploidentical donor transplantation
Available human leukocyte antigen (HLA)-haploidentical donor who meets the following criteria:
- Blood-related family member, including (but not limited to) sibling, offspring, cousin, nephew, or parent. Younger donors should be prioritized.
- At least 18 years of age
- HLA-haploidentical donor/recipient match by at least low-resolution typing per institutional standards.
- In the investigator's opinion, is in general good health, and medically able to tolerate leukapheresis required for harvesting hematopoietic stem cells (HSC).
- No active hepatitis.
- Negative for human T-cell lymphotrophic virus (HTLV) and human immunodeficiency virus (HIV).
- Not pregnant.
- Safety Lead-In Phase: For the first three patients, the donor must consent to a second product collection should it prove necessary.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Adequate organ function as defined below:
- Total bilirubin must be within normal range at baseline
- Aspartate aminotransferase (AST)(SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3.0 x institutional upper limit of normal (IULN).
- Creatinine ≤ 1.5 x IULN OR creatinine clearance ≥ 45 mL/min/1.73 m^2 by Cockcroft-Gault Formula.
- Oxygen saturation ≥ 90% on room air.
- Left ventricular ejection fraction (LVEF) ≥ 40%.
- Forced expiratory volume (FEV1) and forced vital capacity (FVC) ≥ 40% predicted, diffusing capacity of the lung for carbon monoxide (DLCOc) ≥ 40% predicted. If DLCO is < 40%, patients will still be considered eligible if deemed safe after a pulmonary evaluation.
At least 18 years of age at the time of study registration
Able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document (or that of legally authorized representative, if applicable).
Must be able to receive GVHD prophylaxis with tacrolimus, mycophenolate mofetil, and cyclophosphamide

Exclusion Criteria:

Must not have undergone a prior allogeneic donor (related, unrelated, or cord) transplant. Prior autologous transplant is not exclusionary.
Presence of donor-specific antibodies (DSA) with Mean Fluorescence Intensity (MFI) of ≥2000 as assessed by the single antigen bead assay.
Known HIV or active hepatitis B or C infection.
Known hypersensitivity to one or more of the study agents, including Ruxolitinib and Itacitinib.
Must not have myelofibrosis (unless they are enrolled Amendment #5 or later) or other disease known to prolong neutrophil engraftment to > 35 days after transplant.
Must not receive antithymocyte globulin as part of pre-transplant conditioning regimens.
Currently receiving or has received any investigational drugs within the 14 days prior to the first dose of study drug (Day -3).
Pregnant and/or breastfeeding.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, autoimmune disease, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements.
Immunosuppressive doses of steroids. Subjects with steroids for adrenal insufficiency will not be excluded.

Additional Inclusion Criteria Under Amendment 5

Five subjects with myelofibrosis will be enrolled in the expansion phase.
Three patients whose donors fail to collect the target number of CD34+ cells and the treating physician choses to move forward with the haplo-HCT will be enrolled in the expansion phase.

Contacts/Locations Module

Name	Affiliation	Role
Ramzi Abboud, 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
39576962	Derived	Abboud R, Schroeder MA, Rettig MP, Jayasinghe RG, Gao F, Eisele J, Gehrs L, Ritchey J, Choi J, Abboud CN, Pusic I, Jacoby M, Westervelt P, Christopher M, Cashen A, Ghobadi A, Stockerl-Goldstein K, Uy GL, DiPersio JF. Itacitinib for prevention of graft-versus-host disease and cytokine release syndrome in haploidentical transplantation. Blood. 2025 Mar 27;145(13):1382-1394. doi: 10.1182/blood.2024026497.

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	Pilot Study: Itacitinib	Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy Stem cell transplantation on Day 0 Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.

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	Jun 1, 2023

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

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Pilot Study: Itacitinib	Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy Stem cell transplantation on Day 0 Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.
BG001	Expansion Phase: Itacitinib	Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy Stem cell transplantation on Day 0 Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently
BG002	Donors	-Donors were consented for the patients enrolled in the Safety Lead-In Phase (planned 3 patients). Donors were consented for a second CD34+ collection to use as a rescue in the case of engraftment failure and for collection of a research blood specimen prior to mobilization.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00022 BG00127 BG0026 BG00355

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
	BG00057.5(20 to 73) BG00161(19 to 72) BG00237.5(27 to 45) BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00010 BG0019 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 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
	BG00022 BG00127 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

Number of Participants With Graft Failure (Pilot Study Only)

Failure to engraft will be defined as failure to achieve absolute neutrophil count >500 for 3 days by day 35.

Donors and participants in the Expansion Phase were not evaluable for this outcome measure. There were 2 participants in the Pilot Study who were not evaluable due to not continuing with treatment due to low donor collection.

Posted

Count of Participants

Participants

By day 35

ID	Title	Description
OG000	Pilot Study: Itacitinib	Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy Stem cell transplantation on Day 0 Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.
OG001	Expansion Phase: Itacitinib	Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy Stem cell transplantation on Day 0 Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently
OG002	Donors	-Donors were consented for the patients enrolled in the Safety Lead-In Phase (planned 3 patients). Donors were consented for a second CD34+ collection to use as a rescue in the case of engraftment failure and for collection of a research blood specimen prior to mobilization.

Units	Counts
Participants	OG00020 OG0010 OG0020

Title

Denominators

Categories

Title	Measurements
	OG0000

Primary

Number of Participants With Grades III-IV Acute GVHD

-Incidence of acute grade III-IV GVHD will be assessed using Mount Sinai Acute GvHD International Consortium (MAGIC) criteria. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).

Donors were not evaluable for this outcome measure. There were 2 participants in the Pilot Study and 2 participants in the Expansion Phase who were not evaluable for this outcome measure.

Posted

Count of Participants

Participants

Through day 100

ID	Title	Description
OG000	Pilot Study: Itacitinib	Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy Stem cell transplantation on Day 0 Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.
OG001	Expansion Phase: Itacitinib	Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy Stem cell transplantation on Day 0 Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently

Secondary

Number of Participants Who Experience Cytokine Release Syndrome (CRS)

The number of participants who experience CRS will be summarized by count of participants who experience Grade 1, 2, 3, 4, & 5 CRS. The worst grade experienced by participant will be noted.
Grade 1: symptoms not life threatening & require symptomatic treatment alone, includes fever, nausea, fatigue, malaise
Grade 2: symptoms require/respond to limited intervention - oxygen (O2) <40%, <=3 liters (L) nasal cannula or hypotension responsive to fluids or low dose of 1 vasopressor or grade 2 renal or hepatic toxicity
Grade 3: symptoms require/respond to aggressive intervention - O2 >=40%, >3L nasal cannula or hypotension requiring high dose or multiple vasopressors or grade 3 renal toxicity or grade 4 transaminitis, new onset altered mental status, new cardiomyopathy without wall motion abnormality
Grade 4: life-threatening symptoms - requirement for ventilator support or grade 4 rental toxicity (excluding transaminitis)
Grade 5: death

Donors were not evaluable for this outcome measure. There were 2 participants in the Pilot Study and 2 participants in the Expansion Phase who were not evaluable for this outcome measure.

Posted

Count of Participants

Participants

Through day 28

ID	Title	Description
OG000	Pilot Study: Itacitinib	Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy Stem cell transplantation on Day 0 Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.

Secondary

Number of Participants With Treatment Related Mortality

-Death that results from a transplant procedure-related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause

Donors were not evaluable for this outcome measure. There were 2 participants in the Pilot Study and 2 participants in the Expansion Phase who were not evaluable for this outcome measure.

Posted

Count of Participants

Participants

Day 180

ID	Title	Description
OG000	Pilot Study: Itacitinib	Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy Stem cell transplantation on Day 0 Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.
OG001	Expansion Phase: Itacitinib	Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy Stem cell transplantation on Day 0 Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently

Secondary

Cumulative Incidence of Grades II-IV Acute GVHD (Expansion Phase)

Incidence of acute grade II-IV GVHD will be assessed using Mount Sinai Acute GvHD International Consortium (MAGIC) criteria. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).
The cumulative incidence of aGVHD was estimated using Fine-Gray's sub-distribution methods to account for competing risk of death without aGVHD.

Donors and participants in the Pilot Phase are not evaluable for this outcome measure. There were 2 participants in the Expansion Phase who were not evaluable for this outcome measure.

Posted

Number

95% Confidence Interval

percent

Day 100

ID	Title	Description
OG000	Pilot Study: Itacitinib	Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy Stem cell transplantation on Day 0 Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.
OG001	Expansion Phase: Itacitinib

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	Pilot Study: Itacitinib	Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy Stem cell transplantation on Day 0 Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.	3	20	14	20	20	20
EG001	Expansion Phase: Itacitinib	Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy Stem cell transplantation on Day 0 Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently	8	25	24	26	26	26
EG002	Donors	-Donors were consented for the patients enrolled in the Safety Lead-In Phase (planned 3 patients). Donors were consented for a second CD34+ collection to use as a rescue in the case of engraftment failure and for collection of a research blood specimen prior to mobilization.	0	0	0	0	0	0

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Febrile neutropenia	Blood and lymphatic system disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0012 affected26 at risk EG0020 at risk
Diarrhea	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment	EG0003 affected20 at risk EG0010 affected26 at risk EG0020 at risk
Enterocolitis	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected26 at risk EG0020 at risk
Nausea	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment	EG0002 affected20 at risk EG0012 affected26 at risk EG0020 at risk
Fever	General disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0014 affected26 at risk EG0020 at risk
Adenovirus	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected26 at risk EG0020 at risk
CMV viremia	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected26 at risk EG0020 at risk
COVID-19 infection	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Enterococcus bacteremia	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Enterocolitis infectious	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment	EG0002 affected20 at risk EG0013 affected26 at risk EG0020 at risk
HSV stomatitis	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected26 at risk EG0020 at risk
Lung infection	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment	EG0004 affected20 at risk EG0015 affected26 at risk EG0020 at risk
MSSA bacteremia septic arthritis	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
RSV infection	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Sepsis	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0012 affected26 at risk EG0020 at risk
Skin infection	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0012 affected26 at risk EG0020 at risk
Hyperkalemia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Hyponatremia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Flank pain	Musculoskeletal and connective tissue disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected26 at risk EG0020 at risk
Relapsed disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0013 affected26 at risk EG0020 at risk
Reversible posterior leukoencephalopathy syndrome	Nervous system disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Acute kidney injury	Renal and urinary disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0012 affected26 at risk EG0020 at risk
Cystitis noninfective	Renal and urinary disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Hematuria	Renal and urinary disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected26 at risk EG0020 at risk
Renal colic	Renal and urinary disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected26 at risk EG0020 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected26 at risk EG0020 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected26 at risk EG0020 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0013 affected26 at risk EG0020 at risk
Febrile neutropenia	Blood and lymphatic system disorders	CTCAE (Unspecified)	Systematic Assessment	EG00013 affected20 at risk EG00113 affected26 at risk EG0020 at risk
Supraventricular tachycardia	Cardiac disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Colitis	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected26 at risk EG0020 at risk
Dysphagia	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Esophagitis	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Mucositis oral	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment	EG0007 affected20 at risk EG0015 affected26 at risk EG0020 at risk
Nausea	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Rectal pain	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Cytokine release syndrome	Immune system disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected26 at risk EG0020 at risk
BK virus	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected26 at risk EG0020 at risk
Enterococcus faecium bacteremia	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Enterocolitis infectious	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Lung infection	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Paronychia	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected26 at risk EG0020 at risk
Sepsis	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0012 affected26 at risk EG0020 at risk
Urinary tract infection	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Alanine aminotransferase increased	Investigations	CTCAE (Unspecified)	Systematic Assessment	EG0002 affected20 at risk EG0014 affected26 at risk EG0020 at risk
Alkaline phosphatase increased	Investigations	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0012 affected26 at risk EG0020 at risk
Aspartate aminotransferase increased	Investigations	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0013 affected26 at risk EG0020 at risk
Creatinine increased	Investigations	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Electrocardiogram QT corrected interval prolonged	Investigations	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0012 affected26 at risk EG0020 at risk
Lymphocyte count decreased	Investigations	CTCAE (Unspecified)	Systematic Assessment	EG0002 affected20 at risk EG00113 affected26 at risk EG0020 at risk
Neutrophil count decreased	Investigations	CTCAE (Unspecified)	Systematic Assessment	EG00019 affected20 at risk EG00118 affected26 at risk EG0020 at risk
Platelet count decreased	Investigations	CTCAE (Unspecified)	Systematic Assessment	EG00019 affected20 at risk EG00116 affected26 at risk EG0020 at risk
Weight loss	Investigations	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0012 affected26 at risk EG0020 at risk
White blood cell decreased	Investigations	CTCAE (Unspecified)	Systematic Assessment	EG00020 affected20 at risk EG00117 affected26 at risk EG0020 at risk
Anorexia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Hyperglycemia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected26 at risk EG0020 at risk
Hypernatremia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected26 at risk EG0020 at risk
Hyperphosphatemia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Hypertriglyceridemia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0015 affected26 at risk EG0020 at risk
Hypocalcemia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Hypokalemia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0012 affected26 at risk EG0020 at risk
Hypomagnesemia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0012 affected26 at risk EG0020 at risk
Hyponatremia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected26 at risk EG0020 at risk
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Encephalopathy	Nervous system disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Headache	Nervous system disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Tremor	Nervous system disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected26 at risk EG0020 at risk
Insomnia	Psychiatric disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0013 affected26 at risk EG0020 at risk
Acute kidney injury	Renal and urinary disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk
Renal calculi	Renal and urinary disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected26 at risk EG0020 at risk
Hypotension	Vascular disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected26 at risk EG0020 at risk

ID	Term
D015470	Leukemia, Myeloid, Acute
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D009190	Myelodysplastic Syndromes
D008228	Lymphoma, Non-Hodgkin
D006689	Hodgkin Disease

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007945	Leukemia, Lymphoid
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D001855	Bone Marrow Diseases
D008223	Lymphoma

ID	Term
D033581	Stem Cell Transplantation
C000718170	itacitinib

ID	Term
D017690	Cell Transplantation
D064987	Cell- and Tissue-Based Therapy
D001691	Biological Therapy
D013812	Therapeutics
D014180	Transplantation
D013514	Surgical Procedures, Operative