TriangleNCT00586924 · OUTCOME
CD22 Expression Levels From Peripheral Blood by Best Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- sites per cell
- Interval / dispersion
- Standard Deviation
- Time frame
- Prior to enrollment during screening, and for participants still having malignant cells, the test was to be repeated prior to each cycle of therapy, at the end of treatment, and end of the study (approximately 8 years)
What was measured
Participants malignant cells (peripheral blood) were tested for cluster of differentiation 22 (CD22) expression by fluorescence-activated cell sorter (FACS) analysis.
Analysis population: Safety population included all participants who received any treatment of moxetumomab pasudotox.
Groups in this outcome
5 mcg/kg
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
10 mcg/kg
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
20 mcg/kg
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
30 mcg/kg
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
40 mcg/kg
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
50 mcg/kg
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
| Group | Source count |
|---|---|
| 5 mcg/kg | 3 |
| 10 mcg/kg | 3 |
| 20 mcg/kg | 3 |
| 30 mcg/kg | 3 |
| 40 mcg/kg | 4 |
| 50 mcg/kg | 33 |
Reported measurements
Peripheral Blood: Complete Response
| Group | Source count |
|---|---|
| 5 mcg/kg | 0 |
| 10 mcg/kg | 1 |
| 20 mcg/kg | 2 |
| 30 mcg/kg | 1 |
| 40 mcg/kg | 1 |
| 50 mcg/kg | 18 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mcg/kg | 65434.0 | NA | Not reported | Not reported | Standard deviation was not evaluable since only 1 participant was evaluated. |
| 20 mcg/kg | 72632.0 | 12010.9 | Not reported | Not reported | Not reported |
| 30 mcg/kg | 43803.0 | NA | Not reported | Not reported | Standard deviation was not evaluable since only 1 participant was evaluated. |
| 40 mcg/kg | 61773.0 | NA | Not reported | Not reported | Standard deviation was not evaluable since only 1 participant was evaluated. |
| 50 mcg/kg | 68141.3 | 13614.0 | Not reported | Not reported | Not reported |
Peripheral Blood: Partial Response
| Group | Source count |
|---|---|
| 5 mcg/kg | 3 |
| 10 mcg/kg | 1 |
| 20 mcg/kg | 0 |
| 30 mcg/kg | 1 |
| 40 mcg/kg | 1 |
| 50 mcg/kg | 7 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 5 mcg/kg | 38402.7 | 14131.9 | Not reported | Not reported | Not reported |
| 10 mcg/kg | 78356.0 | NA | Not reported | Not reported | Standard deviation was not evaluable since only 1 participant was evaluated. |
| 30 mcg/kg | 76264.0 | NA | Not reported | Not reported | Standard deviation was not evaluable since only 1 participant was evaluated. |
| 40 mcg/kg | 52495.0 | NA | Not reported | Not reported | Standard deviation was not evaluable since only 1 participant was evaluated. |
| 50 mcg/kg | 33259.9 | 25479.5 | Not reported | Not reported | Not reported |
Peripheral Blood: Stable Disease
| Group | Source count |
|---|---|
| 5 mcg/kg | 0 |
| 10 mcg/kg | 0 |
| 20 mcg/kg | 1 |
| 30 mcg/kg | 1 |
| 40 mcg/kg | 0 |
| 50 mcg/kg | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 20 mcg/kg | 38939.0 | NA | Not reported | Not reported | Standard deviation was not evaluable since only 1 participant was evaluated. |
| 30 mcg/kg | 84157.0 | NA | Not reported | Not reported | Standard deviation was not evaluable since only 1 participant was evaluated. |
| 50 mcg/kg | 46089.3 | 9644.6 | Not reported | Not reported | Not reported |
Peripheral Blood: ProgressiveDisease
| Group | Source count |
|---|---|
| 5 mcg/kg | 0 |
| 10 mcg/kg | 0 |
| 20 mcg/kg | 0 |
| 30 mcg/kg | 0 |
| 40 mcg/kg | 1 |
| 50 mcg/kg | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 40 mcg/kg | 24645.0 | NA | Not reported | Not reported | Standard deviation was not evaluable since only 1 participant was evaluated. |
Complete source fields
- classes
- categories
- measurements
- comment
- Standard deviation was not evaluable since only 1 participant was evaluated.
- group Id
- OG001
- spread
- NA
- value
- 65434.0
- group Id
- OG002
- spread
- 12010.9
- value
- 72632.0
- comment
- Standard deviation was not evaluable since only 1 participant was evaluated.
- group Id
- OG003
- spread
- NA
- value
- 43803.0
- comment
- Standard deviation was not evaluable since only 1 participant was evaluated.
- group Id
- OG004
- spread
- NA
- value
- 61773.0
- group Id
- OG005
- spread
- 13614.0
- value
- 68141.3
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 18
- units
- Participants
- title
- Peripheral Blood: Complete Response
- categories
- measurements
- group Id
- OG000
- spread
- 14131.9
- value
- 38402.7
- comment
- Standard deviation was not evaluable since only 1 participant was evaluated.
- group Id
- OG001
- spread
- NA
- value
- 78356.0
- comment
- Standard deviation was not evaluable since only 1 participant was evaluated.
- group Id
- OG003
- spread
- NA
- value
- 76264.0
- comment
- Standard deviation was not evaluable since only 1 participant was evaluated.
- group Id
- OG004
- spread
- NA
- value
- 52495.0
- group Id
- OG005
- spread
- 25479.5
- value
- 33259.9
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 7
- units
- Participants
- title
- Peripheral Blood: Partial Response
- categories
- measurements
- comment
- Standard deviation was not evaluable since only 1 participant was evaluated.
- group Id
- OG002
- spread
- NA
- value
- 38939.0
- comment
- Standard deviation was not evaluable since only 1 participant was evaluated.
- group Id
- OG003
- spread
- NA
- value
- 84157.0
- group Id
- OG005
- spread
- 9644.6
- value
- 46089.3
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 3
- units
- Participants
- title
- Peripheral Blood: Stable Disease
- categories
- measurements
- comment
- Standard deviation was not evaluable since only 1 participant was evaluated.
- group Id
- OG004
- spread
- NA
- value
- 24645.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- units
- Participants
- title
- Peripheral Blood: ProgressiveDisease
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 33
- units
- Participants
- description
- Participants malignant cells (peripheral blood) were tested for cluster of differentiation 22 (CD22) expression by fluorescence-activated cell sorter (FACS) analysis.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
- id
- OG000
- title
- 5 mcg/kg
- description
- Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
- id
- OG001
- title
- 10 mcg/kg
- description
- Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
- id
- OG002
- title
- 20 mcg/kg
- description
- Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
- id
- OG003
- title
- 30 mcg/kg
- description
- Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
- id
- OG004
- title
- 40 mcg/kg
- description
- Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
- id
- OG005
- title
- 50 mcg/kg
- param Type
- MEAN
- population Description
- Safety population included all participants who received any treatment of moxetumomab pasudotox.
- reporting Status
- POSTED
- time Frame
- Prior to enrollment during screening, and for participants still having malignant cells, the test was to be repeated prior to each cycle of therapy, at the end of treatment, and end of the study (approximately 8 years)
- title
- CD22 Expression Levels From Peripheral Blood by Best Response
- type
- SECONDARY
- unit Of Measure
- sites per cell
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice