NCT01810588 · BASELINE

Baseline characteristics

Targeting the IPA and Matching for the Non-Inherited Maternal Antigen for Haplo-Cord Transplantation · Source last updated 2026-08-19

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

denoms

counts
group Id
BG000
value
15
group Id
BG001
value
20
group Id
BG002
value
25
group Id
BG003
value
210
group Id
BG004
value
270
units
Participants

groups

description
All subjects in this cohort will receive a minimal cell dose of 2 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit. Haplo-cord transplantation: All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past. For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products. In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
id
BG000
title
Cohort 1 - Minimum Cell Dose 2 x 10^7 TNC/kg
description
All subjects in this cohort will receive a minimal cell dose of 1 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit. Haplo-cord transplantation: All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past. For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products. In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
id
BG001
title
Cohort 2 - Minimum Cell Dose 1 x 10^7 TNC/kg
description
All subjects in this cohort will receive a minimal cell dose of 0.5 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit. Haplo-cord transplantation: All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past. For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products. In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
id
BG002
title
Cohort 3 - Minimum Cell Dose 0.5 x 10^7 TNC/kg
description
All subjects in this cohort will receive the minimum required cell dose that is determined following the dose de-escalation portion of the study (cohorts 1 through 3) Haplo-cord transplantation: All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past. For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products. In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
id
BG003
title
Cohort 4
description
Total of all reporting groups
id
BG004
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
0
title
<=18 years
measurements
group Id
BG000
value
11
group Id
BG001
value
13
group Id
BG002
value
15
group Id
BG003
value
164
group Id
BG004
value
203
title
Between 18 and 65 years
measurements
group Id
BG000
value
4
group Id
BG001
value
7
group Id
BG002
value
10
group Id
BG003
value
46
group Id
BG004
value
67
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
7
group Id
BG002
value
11
group Id
BG003
value
94
group Id
BG004
value
119
title
Female
measurements
group Id
BG000
value
8
group Id
BG001
value
13
group Id
BG002
value
14
group Id
BG003
value
116
group Id
BG004
value
151
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
3
group Id
BG003
value
16
group Id
BG004
value
20
title
Hispanic or Latino
measurements
group Id
BG000
value
8
group Id
BG001
value
14
group Id
BG002
value
13
group Id
BG003
value
124
group Id
BG004
value
159
title
Not Hispanic or Latino
measurements
group Id
BG000
value
7
group Id
BG001
value
5
group Id
BG002
value
9
group Id
BG003
value
70
group Id
BG004
value
91
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
3
group Id
BG003
value
30
group Id
BG004
value
34
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
1
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
4
group Id
BG001
value
2
group Id
BG002
value
2
group Id
BG003
value
37
group Id
BG004
value
45
title
Black or African American
measurements
group Id
BG000
value
7
group Id
BG001
value
11
group Id
BG002
value
9
group Id
BG003
value
79
group Id
BG004
value
106
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
0
title
More than one race
measurements
group Id
BG000
value
3
group Id
BG001
value
6
group Id
BG002
value
11
group Id
BG003
value
64
group Id
BG004
value
84
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
20
group Id
BG002
value
25
group Id
BG003
value
210
group Id
BG004
value
270
title
United States
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
10
group Id
BG002
value
16
group Id
BG003
value
109
group Id
BG004
value
144
title
Acute Myeloid Leukemia
measurements
group Id
BG000
value
1
group Id
BG001
value
3
group Id
BG002
value
2
group Id
BG003
value
17
group Id
BG004
value
23
title
Acute Lymphoblastic Leukemia
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
5
group Id
BG004
value
5
title
Chronic Myelogenous Leukemia
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
5
group Id
BG004
value
7
title
Hodgkin's Lymphoma
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
4
group Id
BG003
value
19
group Id
BG004
value
28
title
Non-Hodgkin's Lymphoma
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
group Id
BG003
value
44
group Id
BG004
value
50
title
Myelodysplastic Syndrome
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
5
group Id
BG004
value
5
title
Myeloproliferative Neoplasm
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
3
group Id
BG004
value
3
title
Other Acute Leukemia
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
2
group Id
BG004
value
3
title
Other Leukemia (including Chronic Lymphocytic Leukemia)
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
1
group Id
BG004
value
2
title
Severe Aplastic Anemia
param Type
COUNT_OF_PARTICIPANTS
title
Primary Disease
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
15
group Id
BG001
value
20
group Id
BG002
value
25
group Id
BG003
value
210
group Id
BG004
value
270
units
Participants

groups

description
All subjects in this cohort will receive a minimal cell dose of 2 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit. Haplo-cord transplantation: All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past. For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products. In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
id
BG000
title
Cohort 1 - Minimum Cell Dose 2 x 10^7 TNC/kg
description
All subjects in this cohort will receive a minimal cell dose of 1 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit. Haplo-cord transplantation: All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past. For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products. In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
id
BG001
title
Cohort 2 - Minimum Cell Dose 1 x 10^7 TNC/kg
description
All subjects in this cohort will receive a minimal cell dose of 0.5 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit. Haplo-cord transplantation: All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past. For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products. In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
id
BG002
title
Cohort 3 - Minimum Cell Dose 0.5 x 10^7 TNC/kg
description
All subjects in this cohort will receive the minimum required cell dose that is determined following the dose de-escalation portion of the study (cohorts 1 through 3) Haplo-cord transplantation: All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past. For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products. In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
id
BG003
title
Cohort 4
description
Total of all reporting groups
id
BG004
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
0
title
<=18 years
measurements
group Id
BG000
value
11
group Id
BG001
value
13
group Id
BG002
value
15
group Id
BG003
value
164
group Id
BG004
value
203
title
Between 18 and 65 years
measurements
group Id
BG000
value
4
group Id
BG001
value
7
group Id
BG002
value
10
group Id
BG003
value
46
group Id
BG004
value
67
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
7
group Id
BG002
value
11
group Id
BG003
value
94
group Id
BG004
value
119
title
Female
measurements
group Id
BG000
value
8
group Id
BG001
value
13
group Id
BG002
value
14
group Id
BG003
value
116
group Id
BG004
value
151
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
3
group Id
BG003
value
16
group Id
BG004
value
20
title
Hispanic or Latino
measurements
group Id
BG000
value
8
group Id
BG001
value
14
group Id
BG002
value
13
group Id
BG003
value
124
group Id
BG004
value
159
title
Not Hispanic or Latino
measurements
group Id
BG000
value
7
group Id
BG001
value
5
group Id
BG002
value
9
group Id
BG003
value
70
group Id
BG004
value
91
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
3
group Id
BG003
value
30
group Id
BG004
value
34
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
1
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
4
group Id
BG001
value
2
group Id
BG002
value
2
group Id
BG003
value
37
group Id
BG004
value
45
title
Black or African American
measurements
group Id
BG000
value
7
group Id
BG001
value
11
group Id
BG002
value
9
group Id
BG003
value
79
group Id
BG004
value
106
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
0
title
More than one race
measurements
group Id
BG000
value
3
group Id
BG001
value
6
group Id
BG002
value
11
group Id
BG003
value
64
group Id
BG004
value
84
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
20
group Id
BG002
value
25
group Id
BG003
value
210
group Id
BG004
value
270
title
United States
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
10
group Id
BG002
value
16
group Id
BG003
value
109
group Id
BG004
value
144
title
Acute Myeloid Leukemia
measurements
group Id
BG000
value
1
group Id
BG001
value
3
group Id
BG002
value
2
group Id
BG003
value
17
group Id
BG004
value
23
title
Acute Lymphoblastic Leukemia
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
5
group Id
BG004
value
5
title
Chronic Myelogenous Leukemia
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
5
group Id
BG004
value
7
title
Hodgkin's Lymphoma
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
4
group Id
BG003
value
19
group Id
BG004
value
28
title
Non-Hodgkin's Lymphoma
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
group Id
BG003
value
44
group Id
BG004
value
50
title
Myelodysplastic Syndrome
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
5
group Id
BG004
value
5
title
Myeloproliferative Neoplasm
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
3
group Id
BG004
value
3
title
Other Acute Leukemia
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
2
group Id
BG004
value
3
title
Other Leukemia (including Chronic Lymphocytic Leukemia)
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
1
group Id
BG004
value
2
title
Severe Aplastic Anemia
param Type
COUNT_OF_PARTICIPANTS
title
Primary Disease
unit Of Measure
Participants

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Preserved source evidence · Not medical advice