NCT05350163 · OUTCOME

Incidence of Treatment-emergent Serious Adverse Events (TE-SAEs)

T-cell Receptor α/β Depleted Donor Lymphocyte Infusion · Source last updated 2024-12-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: 30 days post-infusion

What was measured

TE-SAEs are defined as the composite of death, non-fatal pulmonary embolism, stroke, acute graft versus host disease (GvHD), and clinically significant laboratory test abnormalities.

Analysis population: The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially.

Groups in this outcome

HLA Matched Cohort I

5 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients

HLA Matched Cohort II

5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients

HLA Matched Cohort III

5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 2 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients

HLA Mismatched Cohort I

1 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients

HLA Mismatched Cohort II

1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 5 x 10\^5/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients

HLA Mismatched Cohort III

1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
HLA Matched Cohort I	10
HLA Matched Cohort II	0
HLA Matched Cohort III	0
HLA Mismatched Cohort I	1
HLA Mismatched Cohort II	0
HLA Mismatched Cohort III	0

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
HLA Matched Cohort I	1	Not reported	Not reported	Not reported	Not reported
HLA Matched Cohort II	0	Not reported	Not reported	Not reported	Not reported
HLA Matched Cohort III	0	Not reported	Not reported	Not reported	Not reported
HLA Mismatched Cohort I	0	Not reported	Not reported	Not reported	Not reported
HLA Mismatched Cohort II	0	Not reported	Not reported	Not reported	Not reported
HLA Mismatched Cohort III	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0

denoms

counts
group Id
OG000
value
10
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
0
units
Participants

description

TE-SAEs are defined as the composite of death, non-fatal pulmonary embolism, stroke, acute graft versus host disease (GvHD), and clinically significant laboratory test abnormalities.

groups

description
5 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
id
OG000
title
HLA Matched Cohort I
description
5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
id
OG001
title
HLA Matched Cohort II
description
5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 2 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
id
OG002
title
HLA Matched Cohort III
description
1 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
id
OG003
title
HLA Mismatched Cohort I
description
1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 5 x 10\^5/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
id
OG004
title
HLA Mismatched Cohort II
description
1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
id
OG005
title
HLA Mismatched Cohort III

param Type

COUNT_OF_PARTICIPANTS

population Description

The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially.

reporting Status

POSTED

time Frame

30 days post-infusion

title

Incidence of Treatment-emergent Serious Adverse Events (TE-SAEs)

type

PRIMARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice