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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

21 days post-transplant

Results posted on

2026-01-06

Participant Flow

Participant milestones

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

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-transplant

Population: 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

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-transplant

Time 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-transplant

Time 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-transplant

Proportion 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-transplant

Population: 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

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-transplant

Population: 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

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-transplant

Population: 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

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-transplant

Percentage of patients who develop chronic graft-versus-host disease

Outcome measures

Outcome data not reported

Adverse Events

ATG Group I

Serious events: 8 serious events
Other events: 10 other events
Deaths: 5 deaths

ATG Group II

Serious events: 9 serious events
Other events: 10 other events
Deaths: 1 deaths

ATG Group III

Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths

ATG Group IV

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

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

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

Alexandra Gomez Arteaga, MD

Weill Cornell Medicine

Phone: 646-962-7950

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place