Trial Outcomes & Findings for Tildrakizumab for Prevention of Acute Graft-Versus-Host Disease (NCT NCT04112810)
NCT ID: NCT04112810
Last Updated: 2025-10-21
Results Overview
Number of subjects experiencing any of grade III-IV acute GVHD, systemic therapy-requiring chronic GVHD, relapse, or death at 12 months
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
1 year
Results posted on
2025-10-21
Participant Flow
Participant milestones
| Measure |
Tildrakizumab
Tildrakizumab (IluymaTM) is a humanized monoclonal antibody that specifically binds to the IL-23p19 subunit of IL-23 to neutralize its function.
Tildrakizumab: 100 mg will be injected subcutaneously on Day -1, Day 28 ± 3, Day 112 ± 7, Day 196 ± 14, and Day 280 ± 14.
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Tildrakizumab
Tildrakizumab (IluymaTM) is a humanized monoclonal antibody that specifically binds to the IL-23p19 subunit of IL-23 to neutralize its function.
Tildrakizumab: 100 mg will be injected subcutaneously on Day -1, Day 28 ± 3, Day 112 ± 7, Day 196 ± 14, and Day 280 ± 14.
|
|---|---|
|
Overall Study
Only 50 pts are evaluable as 1 pt withdrew before treatment.
|
1
|
Baseline Characteristics
Tildrakizumab for Prevention of Acute Graft-Versus-Host Disease
Baseline characteristics by cohort
| Measure |
Tildrakizumab
n=51 Participants
Tildrakizumab (IluymaTM) is a humanized monoclonal antibody that specifically binds to the IL-23p19 subunit of IL-23 to neutralize its function.
Tildrakizumab: 100 mg will be injected subcutaneously on Day -1, Day 28 ± 3, Day 112 ± 7, Day 196 ± 14, and Day 280 ± 14.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 yearNumber of subjects experiencing any of grade III-IV acute GVHD, systemic therapy-requiring chronic GVHD, relapse, or death at 12 months
Outcome measures
| Measure |
Tildrakizumab
n=50 Participants
Tildrakizumab (IluymaTM) is a humanized monoclonal antibody that specifically binds to the IL-23p19 subunit of IL-23 to neutralize its function.
Tildrakizumab: 100 mg will be injected subcutaneously on Day -1, Day 28 ± 3, Day 112 ± 7, Day 196 ± 14, and Day 280 ± 14.
|
|---|---|
|
GVHD-free Relapse-Free Survival
|
19.3 percentage of subjects
Interval 11.8 to 31.4
|
SECONDARY outcome
Timeframe: Day +180Number of subjects experiencing chronic GVHD defined by NIH Consensus criteria.
Outcome measures
| Measure |
Tildrakizumab
n=50 Participants
Tildrakizumab (IluymaTM) is a humanized monoclonal antibody that specifically binds to the IL-23p19 subunit of IL-23 to neutralize its function.
Tildrakizumab: 100 mg will be injected subcutaneously on Day -1, Day 28 ± 3, Day 112 ± 7, Day 196 ± 14, and Day 280 ± 14.
|
|---|---|
|
Incidence of Chronic GVHD
|
18 percentage of subjects
Interval 10.0 to 32.5
|
SECONDARY outcome
Timeframe: Day +365Number of subjects experiencing chronic GVHD defined by NIH Consensus criteria.
Outcome measures
| Measure |
Tildrakizumab
n=50 Participants
Tildrakizumab (IluymaTM) is a humanized monoclonal antibody that specifically binds to the IL-23p19 subunit of IL-23 to neutralize its function.
Tildrakizumab: 100 mg will be injected subcutaneously on Day -1, Day 28 ± 3, Day 112 ± 7, Day 196 ± 14, and Day 280 ± 14.
|
|---|---|
|
Incidence of Chronic GVHD
|
53.7 percentage of subjects
Interval 40.4 to 68.9
|
SECONDARY outcome
Timeframe: Day +100 and Day +180Number of subjects experiencing grades II-IV and III-IV acute GVHD will be determined at Day +100 and Day +180 post-HCT. Acute GVHD will be graded according to NIH Consensus criteria.
Outcome measures
| Measure |
Tildrakizumab
n=50 Participants
Tildrakizumab (IluymaTM) is a humanized monoclonal antibody that specifically binds to the IL-23p19 subunit of IL-23 to neutralize its function.
Tildrakizumab: 100 mg will be injected subcutaneously on Day -1, Day 28 ± 3, Day 112 ± 7, Day 196 ± 14, and Day 280 ± 14.
|
|---|---|
|
Incidence of Acute GVHD
Grade II-IV; Day +100
|
14 percentage of subjects
Interval 7.0 to 27.8
|
|
Incidence of Acute GVHD
Grade II-IV; Day +180
|
18 percentage of subjects
Interval 10.0 to 32.5
|
|
Incidence of Acute GVHD
Grade III-IV; Day +100
|
4 percentage of subjects
Interval 1.0 to 15.6
|
|
Incidence of Acute GVHD
Grade III-IV; Day +180
|
4 percentage of subjects
Interval 1.0 to 15.6
|
SECONDARY outcome
Timeframe: Day +100 and Day +180Number of subjects experiencing grades II-IV and III-IV acute GI GVHD will be determined at Day +100 and Day +180 post-HCT. This will be graded according to NIH Consensus criteria.
Outcome measures
| Measure |
Tildrakizumab
n=50 Participants
Tildrakizumab (IluymaTM) is a humanized monoclonal antibody that specifically binds to the IL-23p19 subunit of IL-23 to neutralize its function.
Tildrakizumab: 100 mg will be injected subcutaneously on Day -1, Day 28 ± 3, Day 112 ± 7, Day 196 ± 14, and Day 280 ± 14.
|
|---|---|
|
Incidence of Acute GI GVHD
Grade III-IV; Day +100
|
4 percentage of subjects
Interval 1.0 to 15.6
|
|
Incidence of Acute GI GVHD
Grade III-IV; Day +180
|
4 percentage of subjects
Interval 1.0 to 15.6
|
|
Incidence of Acute GI GVHD
Grade II-IV; Day +100
|
6 percentage of subjects
Interval 2.0 to 18.1
|
|
Incidence of Acute GI GVHD
Grade II-IV; Day +180
|
10.3 percentage of subjects
Interval 4.5 to 23.7
|
SECONDARY outcome
Timeframe: Day 28Number of subjects experiencing no neutrophil recovery to \> 500 cells/μL by Day 28 post-HCT.
Outcome measures
| Measure |
Tildrakizumab
n=50 Participants
Tildrakizumab (IluymaTM) is a humanized monoclonal antibody that specifically binds to the IL-23p19 subunit of IL-23 to neutralize its function.
Tildrakizumab: 100 mg will be injected subcutaneously on Day -1, Day 28 ± 3, Day 112 ± 7, Day 196 ± 14, and Day 280 ± 14.
|
|---|---|
|
Primary Graft Failure.
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 365Number of subjects experiencing initial neutrophil engraftment followed by subsequent decline in absolute neutrophil counts \<500 cells/μL, unresponsive to growth factor therapy, but cannot be explained by disease relapse or drugs.
Outcome measures
| Measure |
Tildrakizumab
n=50 Participants
Tildrakizumab (IluymaTM) is a humanized monoclonal antibody that specifically binds to the IL-23p19 subunit of IL-23 to neutralize its function.
Tildrakizumab: 100 mg will be injected subcutaneously on Day -1, Day 28 ± 3, Day 112 ± 7, Day 196 ± 14, and Day 280 ± 14.
|
|---|---|
|
Secondary Graft Failure
|
0 Participants
|
SECONDARY outcome
Timeframe: Day +28This measure is the number of subjects with the event. The number of days to hematopoietic recovery will be assessed according to neutrophil count recovery after hematopoietic stem cell transplant (HSCT). Neutrophil recovery or engraftment is defined as achieving an absolute neutrophil count (ANC) ≥500/mm\^3 for three consecutive measurements on three different days. The first of the three days will be designated the day of neutrophil engraftment.
Outcome measures
| Measure |
Tildrakizumab
n=50 Participants
Tildrakizumab (IluymaTM) is a humanized monoclonal antibody that specifically binds to the IL-23p19 subunit of IL-23 to neutralize its function.
Tildrakizumab: 100 mg will be injected subcutaneously on Day -1, Day 28 ± 3, Day 112 ± 7, Day 196 ± 14, and Day 280 ± 14.
|
|---|---|
|
Hematopoietic Recovery According to Neutrophil Count Recovery
|
50 Participants
|
SECONDARY outcome
Timeframe: Day +28This measure is the number of subjects with the event. The number of days to hematopoietic recovery will be assessed according to platelet count recovery after HSCT. Platelet recovery is defined by either the first day of a sustained platelet count \>20,000/mm\^3 for three days with no platelet transfusion in the preceding seven days. The first day of sustained platelet count above these thresholds will be designated the day of platelet engraftment.
Outcome measures
| Measure |
Tildrakizumab
n=50 Participants
Tildrakizumab (IluymaTM) is a humanized monoclonal antibody that specifically binds to the IL-23p19 subunit of IL-23 to neutralize its function.
Tildrakizumab: 100 mg will be injected subcutaneously on Day -1, Day 28 ± 3, Day 112 ± 7, Day 196 ± 14, and Day 280 ± 14.
|
|---|---|
|
Hematopoietic Recovery According to Platelet Count Recovery
|
47 Participants
|
SECONDARY outcome
Timeframe: Day +100 and 1 yearNumber of subjects who die after alloHCT without experiencing a relapse.
Outcome measures
| Measure |
Tildrakizumab
n=50 Participants
Tildrakizumab (IluymaTM) is a humanized monoclonal antibody that specifically binds to the IL-23p19 subunit of IL-23 to neutralize its function.
Tildrakizumab: 100 mg will be injected subcutaneously on Day -1, Day 28 ± 3, Day 112 ± 7, Day 196 ± 14, and Day 280 ± 14.
|
|---|---|
|
Non-relapsed Mortality.
Day +100
|
2 percentage of subjects
Interval 0.3 to 13.9
|
|
Non-relapsed Mortality.
1 year
|
8 percentage of subjects
Interval 3.1 to 20.5
|
SECONDARY outcome
Timeframe: Day +100 and 1 yearThe number of subjects who experience relapse. Relapse is defined by either morphological, cytogenetic or radiologic evidence of the pretransplant hematologic malignancy.
Outcome measures
| Measure |
Tildrakizumab
n=50 Participants
Tildrakizumab (IluymaTM) is a humanized monoclonal antibody that specifically binds to the IL-23p19 subunit of IL-23 to neutralize its function.
Tildrakizumab: 100 mg will be injected subcutaneously on Day -1, Day 28 ± 3, Day 112 ± 7, Day 196 ± 14, and Day 280 ± 14.
|
|---|---|
|
Disease Relapse or Progression
Day +100
|
14 percentage of subjects
Interval 7.0 to 27.8
|
|
Disease Relapse or Progression
1 year
|
14 percentage of subjects
Interval 7.0 to 27.8
|
SECONDARY outcome
Timeframe: Day +100 and 1 yearThis will be measured in months. The event for this endpoint is relapse/progression or death. Patients who are alive and disease-free will be censored at last follow-up.
Outcome measures
| Measure |
Tildrakizumab
n=50 Participants
Tildrakizumab (IluymaTM) is a humanized monoclonal antibody that specifically binds to the IL-23p19 subunit of IL-23 to neutralize its function.
Tildrakizumab: 100 mg will be injected subcutaneously on Day -1, Day 28 ± 3, Day 112 ± 7, Day 196 ± 14, and Day 280 ± 14.
|
|---|---|
|
The Number of Subjects With Progression-free Survival.
Day +100
|
84 percentage of subjects
Interval 74.4 to 94.8
|
|
The Number of Subjects With Progression-free Survival.
1 year
|
78 percentage of subjects
Interval 67.3 to 90.4
|
SECONDARY outcome
Timeframe: Day +100 and 1 yearThe time in months from the date of transplant to date of death from any cause or for surviving patients, to last follow-up. Patients who are alive and disease-free will be censored at last follow-up.
Outcome measures
| Measure |
Tildrakizumab
n=50 Participants
Tildrakizumab (IluymaTM) is a humanized monoclonal antibody that specifically binds to the IL-23p19 subunit of IL-23 to neutralize its function.
Tildrakizumab: 100 mg will be injected subcutaneously on Day -1, Day 28 ± 3, Day 112 ± 7, Day 196 ± 14, and Day 280 ± 14.
|
|---|---|
|
The Number of Subjects With Overall Survival.
Day +100
|
98 percentage of subjects
Interval 94.2 to 100.0
|
|
The Number of Subjects With Overall Survival.
1 year
|
80 percentage of subjects
Interval 69.7 to 91.9
|
SECONDARY outcome
Timeframe: Day +28, Day +100 and 1 yearNumber of subjects experiencing a grade ≥3 (CTCAE v5) viral, fungal and/or bacterial infections.
Outcome measures
| Measure |
Tildrakizumab
n=50 Participants
Tildrakizumab (IluymaTM) is a humanized monoclonal antibody that specifically binds to the IL-23p19 subunit of IL-23 to neutralize its function.
Tildrakizumab: 100 mg will be injected subcutaneously on Day -1, Day 28 ± 3, Day 112 ± 7, Day 196 ± 14, and Day 280 ± 14.
|
|---|---|
|
Incidence of Infections
Day +28
|
14 percentage of subjects
Interval 7.0 to 27.8
|
|
Incidence of Infections
Day +100
|
16 percentage of subjects
Interval 8.5 to 30.2
|
|
Incidence of Infections
1 Year
|
20.3 percentage of subjects
Interval 11.6 to 35.3
|
Adverse Events
Tildrakizumab
Serious events: 11 serious events
Other events: 50 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Tildrakizumab
n=50 participants at risk
Tildrakizumab (IluymaTM) is a humanized monoclonal antibody that specifically binds to the IL-23p19 subunit of IL-23 to neutralize its function.
Tildrakizumab: 100 mg will be injected subcutaneously on Day -1, Day 28 ± 3, Day 112 ± 7, Day 196 ± 14, and Day 280 ± 14.
|
|---|---|
|
Infections and infestations
Lung Infection - Lactobacillus
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
2/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
4.0%
2/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolisms
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
General disorders
Fever
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Lung Infection
|
4.0%
2/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Hematuria
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Hepatobiliary disorders
Gallbladder pain
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Cardiac disorders
Chest pain
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.0%
2/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Reproductive system and breast disorders
Perineal pain
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Reproductive system and breast disorders
Perineal Abscess
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Delirium
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
5/50 • Number of events 5 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Blood and lymphatic system disorders
Anemia
|
4.0%
2/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Anorexia
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Aspartate aminotransferase increased
|
6.0%
3/50 • Number of events 4 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Blood bilirubin increased
|
2.0%
1/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Nausea
|
6.0%
3/50 • Number of events 3 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
3/50 • Number of events 3 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Alanine aminotransferase increased
|
6.0%
3/50 • Number of events 3 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Acute kidney injury
|
4.0%
2/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
Other adverse events
| Measure |
Tildrakizumab
n=50 participants at risk
Tildrakizumab (IluymaTM) is a humanized monoclonal antibody that specifically binds to the IL-23p19 subunit of IL-23 to neutralize its function.
Tildrakizumab: 100 mg will be injected subcutaneously on Day -1, Day 28 ± 3, Day 112 ± 7, Day 196 ± 14, and Day 280 ± 14.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
4.0%
2/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Abdominal pain
|
12.0%
6/50 • Number of events 6 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Acute kidney injuryAcute kidney injury
|
8.0%
4/50 • Number of events 4 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Agitation
|
4.0%
2/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Alanine aminotransferase increased
|
16.0%
8/50 • Number of events 11 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Anal pain
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Blood and lymphatic system disorders
Anemia
|
60.0%
30/50 • Number of events 79 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Anorexia
|
42.0%
21/50 • Number of events 26 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Anxiety
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Ascites
|
2.0%
1/50 • Number of events 6 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Aspartate aminotransferase increased
|
12.0%
6/50 • Number of events 7 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Bladder perforation
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Bladder spasm
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Blood and lymphatic system disorders
Microangiopathic Hemolytic Anemia
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Blood bilirubin increased
|
4.0%
2/50 • Number of events 5 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Blood and lymphatic system disorders
Bone marrow hypocellular
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Eye disorders
Cataract
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Investigations
CD4 lymphocytes decreased
|
12.0%
6/50 • Number of events 7 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Cardiac disorders
Chest pain - cardiac
|
4.0%
2/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Chronic kidney disease
|
4.0%
2/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
non-productive cough
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Confusion
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Creatinine increased
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Cystitis noninfective
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
4.0%
2/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Delirium
|
4.0%
2/50 • Number of events 3 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Dental caries
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Depression
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Diarrhea
|
26.0%
13/50 • Number of events 17 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Dizziness
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Eye disorders
Dry eye
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Duodenal ulcer
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.0%
8/50 • Number of events 11 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
General disorders
Edema face
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
4.0%
2/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.0%
3/50 • Number of events 3 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Esophagitis
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
General disorders
Fatigue
|
36.0%
18/50 • Number of events 24 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
56.0%
28/50 • Number of events 30 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
General disorders
Fever
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
General disorders
Flu like symptoms
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Hepatobiliary disorders
Gallbladder pain
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Enteritis
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
General disorders
Generalized edema
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Hallucinations
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Headache
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Hematuria
|
4.0%
2/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Blood and lymphatic system disorders
Hemolysis
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Hepatobiliary disorders
Hepatic failure
|
4.0%
2/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Hepatobiliary disorders
Veno-Occlusive Disease (VOD)
|
4.0%
2/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Herpes simplex reactivation
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.0%
3/50 • Number of events 3 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.0%
8/50 • Number of events 10 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Vascular disorders
Hypertension
|
24.0%
12/50 • Number of events 17 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.0%
2/50 • Number of events 3 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.0%
3/50 • Number of events 3 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Vascular disorders
Hypotension
|
4.0%
2/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.0%
7/50 • Number of events 16 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
parainfluenza
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Insomnia
|
8.0%
4/50 • Number of events 4 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Skin GVHD
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Irritability
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Lip pain
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Lung infection
|
8.0%
4/50 • Number of events 4 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Lymphocyte count decreased
|
16.0%
8/50 • Number of events 16 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Mucositis oral
|
52.0%
26/50 • Number of events 31 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Nausea
|
26.0%
13/50 • Number of events 18 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Neutrophil count decreased
|
78.0%
39/50 • Number of events 116 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
General disorders
Non-cardiac chest pain
|
4.0%
2/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Oral pain
|
14.0%
7/50 • Number of events 7 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.0%
4/50 • Number of events 4 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Reproductive system and breast disorders
Perineal pain
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal stenosis
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Platelet count decreased
|
84.0%
42/50 • Number of events 213 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.0%
2/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Word finding difficulties
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Catatonic
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
24.0%
12/50 • Number of events 16 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.0%
2/50 • Number of events 3 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19 Viral pneumonia
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Reproductive system and breast disorders
Scrotal pain
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Sepsis
|
10.0%
5/50 • Number of events 5 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Cardiac disorders
Sinus tachycardia
|
4.0%
2/50 • Number of events 2 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Hepatobiliary disorders
Sinusoidal obstruction syndrome
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
34.0%
17/50 • Number of events 18 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Stomach pain
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Syncope
|
6.0%
3/50 • Number of events 3 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Typhlitis
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Urethral infection
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Reproductive system and breast disorders
Vaginal infection
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
4/50 • Number of events 4 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Weight gain
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Weight loss
|
2.0%
1/50 • Number of events 1 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
|
Investigations
White blood cell decreased
|
80.0%
40/50 • Number of events 122 • 12 months following alloHCT (up to 13 months)
regular investigator assessment, regular laboratory testing
|
Additional Information
William R Drobyski, MD, FACP, FASTCT
Medical College of Wisconsin
Phone: 414-456-4941
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place