NCT03805932 · BASELINE

Baseline characteristics

Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia · Source last updated 2026-06-29

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

denoms

counts
group Id
BG000
value
3
group Id
BG001
value
15
group Id
BG002
value
18
units
Participants

groups

description
Participants with Relapsed/Refractory Hairy Cell Leukemia (HCL) or Hairy Cell Leukemia (HCLv) Arm 1 Moxetumomab Pasudotox-tdfk + Rituximab Dose escalation treatment with moxetumomab -pasudotox-tdfk and rituximab Moxetumomab pasudotox-tdfk is administered at 30-40 ug/Kg intravenous (iv) over 30 min given on days 1, 3, 5 of each cycle. Rituximab will be administered at 375mg/m\^2 iv, 50-400 mg/hour (hr). On cycle 1, Rituximab is given on day -2, on subsequent cycles, Rituximab is given on day 1.
id
BG000
title
Moxetumomab - Dose Escalation 30 mcg/kg
description
Dose expansion; treatment with moxetumomab -pasudotox-tdfk and Ruxience Arm 1 and Arm 2 Moxetumomab Pasudotox-tdfk + Ruxience Moxetumomab pasudotox-tdfk is administered at 30-40 ug/Kg intravenous (iv) over 30 min given on days 1, 3, 5 of each cycle. Ruxience will be administered at 375mg/m\^2 iv, 50-400 mg/hour (hr). On cycle 1, Ruxience is given on day -2, on subsequent cycles, Ruxience is given on day 1 (Delta)
id
BG001
title
Moxetumomab - Dose Expansion 40 mcg/kg
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
<=18 years
measurements
group Id
BG000
value
1
group Id
BG001
value
10
group Id
BG002
value
11
title
Between 18 and 65 years
measurements
group Id
BG000
value
2
group Id
BG001
value
5
group Id
BG002
value
7
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
8.98
value
61.17
group Id
BG001
spread
8.64
value
60.07
group Id
BG002
spread
8.44
value
60.25
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Female
measurements
group Id
BG000
value
3
group Id
BG001
value
14
group Id
BG002
value
17
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
0
group Id
BG002
value
0
title
Hispanic or Latino
measurements
group Id
BG000
value
3
group Id
BG001
value
15
group Id
BG002
value
18
title
Not Hispanic or Latino
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
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
title
American Indian or Alaska Native
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Black or African American
measurements
group Id
BG000
value
3
group Id
BG001
value
14
group Id
BG002
value
17
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
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
3
group Id
BG001
value
15
group Id
BG002
value
18
title
United States
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants

Complete source fields

denoms

counts
group Id
BG000
value
3
group Id
BG001
value
15
group Id
BG002
value
18
units
Participants

groups

description
Participants with Relapsed/Refractory Hairy Cell Leukemia (HCL) or Hairy Cell Leukemia (HCLv) Arm 1 Moxetumomab Pasudotox-tdfk + Rituximab Dose escalation treatment with moxetumomab -pasudotox-tdfk and rituximab Moxetumomab pasudotox-tdfk is administered at 30-40 ug/Kg intravenous (iv) over 30 min given on days 1, 3, 5 of each cycle. Rituximab will be administered at 375mg/m\^2 iv, 50-400 mg/hour (hr). On cycle 1, Rituximab is given on day -2, on subsequent cycles, Rituximab is given on day 1.
id
BG000
title
Moxetumomab - Dose Escalation 30 mcg/kg
description
Dose expansion; treatment with moxetumomab -pasudotox-tdfk and Ruxience Arm 1 and Arm 2 Moxetumomab Pasudotox-tdfk + Ruxience Moxetumomab pasudotox-tdfk is administered at 30-40 ug/Kg intravenous (iv) over 30 min given on days 1, 3, 5 of each cycle. Ruxience will be administered at 375mg/m\^2 iv, 50-400 mg/hour (hr). On cycle 1, Ruxience is given on day -2, on subsequent cycles, Ruxience is given on day 1 (Delta)
id
BG001
title
Moxetumomab - Dose Expansion 40 mcg/kg
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
<=18 years
measurements
group Id
BG000
value
1
group Id
BG001
value
10
group Id
BG002
value
11
title
Between 18 and 65 years
measurements
group Id
BG000
value
2
group Id
BG001
value
5
group Id
BG002
value
7
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
8.98
value
61.17
group Id
BG001
spread
8.64
value
60.07
group Id
BG002
spread
8.44
value
60.25
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Female
measurements
group Id
BG000
value
3
group Id
BG001
value
14
group Id
BG002
value
17
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
0
group Id
BG002
value
0
title
Hispanic or Latino
measurements
group Id
BG000
value
3
group Id
BG001
value
15
group Id
BG002
value
18
title
Not Hispanic or Latino
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
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
title
American Indian or Alaska Native
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Black or African American
measurements
group Id
BG000
value
3
group Id
BG001
value
14
group Id
BG002
value
17
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
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
3
group Id
BG001
value
15
group Id
BG002
value
18
title
United States
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice