Trial Outcomes & Findings for Tocilizumab for the Prevention of Graft Failure and GVHD in Haplo-Cord Transplantation (NCT NCT04395222)
NCT ID: NCT04395222
Last Updated: 2026-01-06
Results Overview
This is defined as: 1. Achieve an absolute neutrophil count (ANC) of 500 cells/microL for three consecutive days with the first on or prior to Day +21 post-transplant, AND 2. Absence of a second nadir - a drop in the ANC to \<300 cells/microL for five consecutive days - after initial neutrophil recovery.
ACTIVE_NOT_RECRUITING
PHASE2
21 participants
21 days post-transplant
2026-01-06
Participant Flow
Participant milestones
| Measure |
ATG Group I
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, Day -3 and Day -1 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group II
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, and Day -3 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group III
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group IV
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
1
|
0
|
|
Overall Study
COMPLETED
|
10
|
10
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tocilizumab for the Prevention of Graft Failure and GVHD in Haplo-Cord Transplantation
Baseline characteristics by cohort
| Measure |
ATG Group I
n=10 Participants
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, Day -3 and Day -1 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group II
n=10 Participants
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, and Day -3 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group III
n=1 Participants
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group IV
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
18-29 years
|
1 Participants
n=37 Participants
|
2 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
1 Participants
n=37 Participants
|
2 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
1 Participants
n=37 Participants
|
2 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
0 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
7 Participants
n=37 Participants
|
3 Participants
n=56 Participants
|
1 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=37 Participants
|
5 Participants
n=56 Participants
|
1 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=37 Participants
|
5 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=37 Participants
|
3 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=37 Participants
|
7 Participants
n=56 Participants
|
1 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=37 Participants
|
2 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=37 Participants
|
6 Participants
n=56 Participants
|
1 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=37 Participants
|
10 participants
n=56 Participants
|
1 participants
n=82 Participants
|
—
|
21 participants
n=5 Participants
|
|
Primary Malignancy
Acute Myeloid Leukemia
|
5 Participants
n=37 Participants
|
5 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
10 Participants
n=5 Participants
|
|
Primary Malignancy
Myelodysplastic Syndrome
|
1 Participants
n=37 Participants
|
3 Participants
n=56 Participants
|
1 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
5 Participants
n=5 Participants
|
|
Primary Malignancy
Myeloproliferative Neoplasm
|
1 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=5 Participants
|
|
Primary Malignancy
Non-Hodgkin Lymphoma
|
2 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=5 Participants
|
|
Primary Malignancy
Other Acute Leukemia
|
1 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 days post-transplantPopulation: No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
This is defined as: 1. Achieve an absolute neutrophil count (ANC) of 500 cells/microL for three consecutive days with the first on or prior to Day +21 post-transplant, AND 2. Absence of a second nadir - a drop in the ANC to \<300 cells/microL for five consecutive days - after initial neutrophil recovery.
Outcome measures
| Measure |
ATG Group I
n=10 Participants
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, Day -3 and Day -1 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group II
n=10 Participants
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, and Day -3 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group III
n=1 Participants
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group IV
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
|---|---|---|---|---|
|
Percentage of Subjects With Successful Haplo-derived Neutrophil Engraftment
|
80 percentage of participants
|
50 percentage of participants
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 5 years post-transplantTime elapsed between Day 0 and progression of the underlying malignancy for which the transplant was performed, assessed up to 5 years post-transplant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 years post-transplantTime elapsed between Day 0 and death from any cause, assessed up to 5 years post-transplant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 years post-transplantProportion of deaths which cannot be explained by persistence, relapse or progression of the underlying malignancy once the preparative regimen starts, assessed up to 5 years post-transplant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months post-transplantPopulation: No subjects were enrolled to ATG Group IV, study enrollment was stopped before accrual reached that cohort.
Proportion of patients who successfully achieve platelet engraftment, defined as a platelet count of \>20k/microL for three consecutive days without transfusion support for seven consecutive days.
Outcome measures
| Measure |
ATG Group I
n=10 Participants
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, Day -3 and Day -1 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group II
n=10 Participants
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, and Day -3 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group III
n=1 Participants
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group IV
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
|---|---|---|---|---|
|
Proportion of Platelet Engraftment Success
|
10 Participants
|
10 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 21 days post-transplantPopulation: No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
Proportion of patients with a failed haplo-graft, defined as the absence of neutrophil engraftment by Day +21 or a drop in the absolute neutrophil count to \<0.3 cells/microL for five consecutive days occurring after initial neutrophil engraftment within the first 3 weeks post-transplantation (second nadir)
Outcome measures
| Measure |
ATG Group I
n=10 Participants
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, Day -3 and Day -1 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group II
n=10 Participants
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, and Day -3 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group III
n=1 Participants
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group IV
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
|---|---|---|---|---|
|
Proportion of Failure of the Haplo-Graft
|
2 Participants
|
5 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 year post-transplantPopulation: No subjects were enrolled to ATG Group IV, study enrollment was stopped before accrual reached that cohort.
Proportion of patients who develop acute graft-versus-host disease
Outcome measures
| Measure |
ATG Group I
n=10 Participants
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, Day -3 and Day -1 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group II
n=10 Participants
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, and Day -3 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group III
n=1 Participants
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group IV
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
|---|---|---|---|---|
|
Proportion of Acute Graft-versus-Host Disease
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 years post-transplantPercentage of patients who develop chronic graft-versus-host disease
Outcome measures
Outcome data not reported
Adverse Events
ATG Group I
ATG Group II
ATG Group III
ATG Group IV
Serious adverse events
| Measure |
ATG Group I
n=10 participants at risk
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, Day -3 and Day -1 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group II
n=10 participants at risk
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, and Day -3 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group III
n=1 participants at risk
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group IV
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
|---|---|---|---|---|
|
Investigations
Acute Graft-versus-Host Disease
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
100.0%
1/1 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Bacteremia
|
20.0%
2/10 • Number of events 2 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
20.0%
2/10 • Number of events 2 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Blood and lymphatic system disorders
Hemophagocytic lymphohistiocytosis
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Hepatobiliary disorders
Cholecystitis
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Colitis - Cytomegalovirus
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Investigations
Delayed Engraftment
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
100.0%
1/1 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
2/10 • Number of events 2 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
General disorders
Failure to Thrive
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
General disorders
Fever
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
General disorders
Hypovolemic shock
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
100.0%
1/1 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Blood and lymphatic system disorders
Hemolytic Anemia
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Herpes simplex Reactivation
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 2 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Lung Infection - COVID-19
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Lung Infection -Chlamydia trachomatis
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Adenocarcinoma
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
10.0%
1/10 • Number of events 2 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Sepsis
|
20.0%
2/10 • Number of events 2 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Investigations
Septic Shock
|
20.0%
2/10 • Number of events 3 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
100.0%
1/1 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Hepatobiliary disorders
Sinusoidal Obstruction Syndrome
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Pain
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Upper Respiratory Infection - Coronavirus
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Upper Respiratory Infection - Human Metapneumovirus
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Upper Respiratory Infection - Parainfluenza
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Viremia - Cytomegalovirus
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
Other adverse events
| Measure |
ATG Group I
n=10 participants at risk
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, Day -3 and Day -1 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group II
n=10 participants at risk
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, and Day -3 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group III
n=1 participants at risk
Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5 of the transplant conditioning regimen.
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit): Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
ATG Group IV
* Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old)
* Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen.
* Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen.
* Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Tocilizumab: Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine: Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan: Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Total Body Irradiation: Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
90.0%
9/10 • Number of events 9 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
100.0%
10/10 • Number of events 10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
100.0%
1/1 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
4/10 • Number of events 4 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
20.0%
2/10 • Number of events 2 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Investigations
Aspartate aminotransferase increased
|
30.0%
3/10 • Number of events 3 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Investigations
Acute Graft-versus-Host Disease
|
30.0%
3/10 • Number of events 3 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
20.0%
2/10 • Number of events 2 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Viremia - Adenovirus
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Adenovirus Colitis
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Investigations
Alanine aminotransferase increased
|
30.0%
3/10 • Number of events 3 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
30.0%
3/10 • Number of events 3 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
30.0%
3/10 • Number of events 3 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
100.0%
1/1 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
30.0%
3/10 • Number of events 3 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
20.0%
2/10 • Number of events 2 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
100.0%
1/1 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
40.0%
4/10 • Number of events 4 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
40.0%
4/10 • Number of events 4 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
100.0%
1/1 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
30.0%
3/10 • Number of events 3 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
100.0%
1/1 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Gastrointestinal disorders
Mucositis oral
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Investigations
Platelet count decreased
|
60.0%
6/10 • Number of events 6 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
40.0%
4/10 • Number of events 4 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
100.0%
1/1 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Investigations
White blood cell decreased
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
30.0%
3/10 • Number of events 3 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
100.0%
1/1 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Cellulitis
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Vascular disorders
Thromboembolic event
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
20.0%
2/10 • Number of events 3 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
40.0%
4/10 • Number of events 4 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Upper Respiratory Infection - Parainfluenza
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
30.0%
3/10 • Number of events 3 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Upper Respiratory Infection - Rhinovirus
|
20.0%
2/10 • Number of events 2 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
30.0%
3/10 • Number of events 3 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Upper Respiratory Infection - Coronavirus
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
20.0%
2/10 • Number of events 2 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Upper Respiratory Infection - COVID-19
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
20.0%
2/10 • Number of events 2 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Viremia - Cytomegalovirus
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
30.0%
3/10 • Number of events 3 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Upper Respiratory Infection - Respiratory Syncytial Virus
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Blood and lymphatic system disorders
Hemolytic Anemia
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Bacteremia
|
20.0%
2/10 • Number of events 2 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
30.0%
3/10 • Number of events 3 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
100.0%
1/1 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Infectious Colitis
|
20.0%
2/10 • Number of events 2 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
30.0%
3/10 • Number of events 3 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Gastrointestinal disorders
Diverticulitis
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
Candida pharyngitis
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
|
Infections and infestations
BK Virus Cystitis
|
10.0%
1/10 • Number of events 1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/10 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
0.00%
0/1 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
—
0/0 • All-cause mortality is being assessed up to 5 years. SAEs and other non-serious AEs were assessed up to 1 year.
No subjects were enrolled to ATG Group IV; study enrollment was stopped before accrual reached that cohort.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place