TriangleNCT00586924 · OUTCOME
CD22 Expression Levels From Bone Marrow 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 (paraffin block biopsy specimen) were tested for CD22 expression by 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
Bone Marrow: Complete Response
| Group | Source count |
|---|---|
| 5 mcg/kg | 0 |
| 10 mcg/kg | 1 |
| 20 mcg/kg | 0 |
| 30 mcg/kg | 1 |
| 40 mcg/kg | 0 |
| 50 mcg/kg | 10 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mcg/kg | 75157.0 | NA | Not reported | Not reported | Standard deviation was not evaluable since only 1 participant was evaluated. |
| 30 mcg/kg | 50190.0 | NA | Not reported | Not reported | Standard deviation was not evaluable since only 1 participant was evaluated. |
| 50 mcg/kg | 55850.5 | 18482.2 | Not reported | Not reported | Not reported |
Bone Marrow: Partial Response
| Group | Source count |
|---|---|
| 5 mcg/kg | 1 |
| 10 mcg/kg | 0 |
| 20 mcg/kg | 0 |
| 30 mcg/kg | 0 |
| 40 mcg/kg | 0 |
| 50 mcg/kg | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 5 mcg/kg | 36286.0 | NA | Not reported | Not reported | Standard deviation was not evaluable since only 1 participant was evaluated. |
| 50 mcg/kg | 37732.5 | 9918.6 | Not reported | Not reported | Not reported |
Bone Marrow: Stable Disease
| Group | Source count |
|---|---|
| 5 mcg/kg | 0 |
| 10 mcg/kg | 0 |
| 20 mcg/kg | 0 |
| 30 mcg/kg | 1 |
| 40 mcg/kg | 0 |
| 50 mcg/kg | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 30 mcg/kg | 80400.0 | NA | Not reported | Not reported | Standard deviation was not evaluable since only 1 participant was evaluated. |
| 50 mcg/kg | 36767.5 | 720.5 | Not reported | Not reported | Not reported |
Bone Marrow: Progressive Disease
| Group | Source count |
|---|---|
| 5 mcg/kg | 0 |
| 10 mcg/kg | 0 |
| 20 mcg/kg | 0 |
| 30 mcg/kg | 0 |
| 40 mcg/kg | 0 |
| 50 mcg/kg | 0 |
Complete source fields
- classes
- categories
- measurements
- comment
- Standard deviation was not evaluable since only 1 participant was evaluated.
- group Id
- OG001
- spread
- NA
- value
- 75157.0
- comment
- Standard deviation was not evaluable since only 1 participant was evaluated.
- group Id
- OG003
- spread
- NA
- value
- 50190.0
- group Id
- OG005
- spread
- 18482.2
- value
- 55850.5
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 10
- units
- Participants
- title
- Bone Marrow: Complete Response
- categories
- measurements
- comment
- Standard deviation was not evaluable since only 1 participant was evaluated.
- group Id
- OG000
- spread
- NA
- value
- 36286.0
- group Id
- OG005
- spread
- 9918.6
- value
- 37732.5
- denoms
- counts
- 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
- 2
- units
- Participants
- title
- Bone Marrow: Partial Response
- categories
- measurements
- comment
- Standard deviation was not evaluable since only 1 participant was evaluated.
- group Id
- OG003
- spread
- NA
- value
- 80400.0
- group Id
- OG005
- spread
- 720.5
- value
- 36767.5
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- units
- Participants
- title
- Bone Marrow: Stable Disease
- 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
- 0
- group Id
- OG005
- value
- 0
- units
- Participants
- title
- Bone Marrow: Progressive Disease
- 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 (paraffin block biopsy specimen) were tested for CD22 expression by 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 Bone Marrow by Best Response
- type
- SECONDARY
- unit Of Measure
- sites per cell
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Preserved source evidence · Not medical advice