TriangleNCT00648739 · OUTCOME
Percent Of Bound Samalizumab On B-Cell Chronic Lymphocytic Leukemia (B-CLL) Cells In Participants With B-CLL At Baseline (Predose) And Day 1 (Postdose)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- percentage of B-CLL cells bound
- Interval / dispersion
- Full Range
- Time frame
- Baseline (Predose) and Day 1 (Postdose)
What was measured
Bound samalizumab was detected using a monoclonal antibody (mAb) specific for samalizumab. The binding of samalizumab to CD200 on peripheral B-CLL tumor cells was evaluated in participants with B-CLL by flow cytometry and expressed as the percent of B-CLL cells bound by samalizumab. For participants with insufficient numbers of peripheral B-CLL for analysis, the samples were documented as "unevaluable" and an analysis was not performed.
Analysis population: All participants with B-CLL who had evaluable assessments for bound samalizumab were included in the analysis. No participants with B-CLL received samalizumab at the 600 mg/m\^2 dose level.
Groups in this outcome
Samalizumab 50 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Samalizumab 100 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Samalizumab 200 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Samalizumab 300 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Samalizumab 400 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Samalizumab 500 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
| Group | Source count |
|---|---|
| Samalizumab 50 mg/m^2 | 4 |
| Samalizumab 100 mg/m^2 | 5 |
| Samalizumab 200 mg/m^2 | 2 |
| Samalizumab 300 mg/m^2 | 2 |
| Samalizumab 400 mg/m^2 | 3 |
| Samalizumab 500 mg/m^2 | 5 |
Reported measurements
Baseline (Predose)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Samalizumab 50 mg/m^2 | 0.60 | Not reported | 0.3 | 5.9 | Not reported |
| Samalizumab 100 mg/m^2 | 0.80 | Not reported | 0.2 | 2.4 | Not reported |
| Samalizumab 200 mg/m^2 | 0.50 | Not reported | 0.3 | 0.7 | Not reported |
| Samalizumab 300 mg/m^2 | 0.60 | Not reported | 0.5 | 0.7 | Not reported |
| Samalizumab 400 mg/m^2 | 3.20 | Not reported | 1.1 | 5.7 | Not reported |
| Samalizumab 500 mg/m^2 | 1.40 | Not reported | 0.1 | 2.1 | Not reported |
Day 1 (Postdose)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Samalizumab 50 mg/m^2 | 2.50 | Not reported | 1.1 | 4.8 | Not reported |
| Samalizumab 100 mg/m^2 | 3.90 | Not reported | 0.2 | 9.5 | Not reported |
| Samalizumab 200 mg/m^2 | 28.70 | Not reported | 27.8 | 29.6 | Not reported |
| Samalizumab 300 mg/m^2 | 16.80 | Not reported | 5 | 28.6 | Not reported |
| Samalizumab 400 mg/m^2 | 13.50 | Not reported | 1.7 | 71.3 | Not reported |
| Samalizumab 500 mg/m^2 | 3.40 | Not reported | 1 | 47 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.3
- upper Limit
- 5.9
- value
- 0.60
- group Id
- OG001
- lower Limit
- 0.2
- upper Limit
- 2.4
- value
- 0.80
- group Id
- OG002
- lower Limit
- 0.3
- upper Limit
- 0.7
- value
- 0.50
- group Id
- OG003
- lower Limit
- 0.5
- upper Limit
- 0.7
- value
- 0.60
- group Id
- OG004
- lower Limit
- 1.1
- upper Limit
- 5.7
- value
- 3.20
- group Id
- OG005
- lower Limit
- 0.1
- upper Limit
- 2.1
- value
- 1.40
- title
- Baseline (Predose)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.1
- upper Limit
- 4.8
- value
- 2.50
- group Id
- OG001
- lower Limit
- 0.2
- upper Limit
- 9.5
- value
- 3.90
- group Id
- OG002
- lower Limit
- 27.8
- upper Limit
- 29.6
- value
- 28.70
- group Id
- OG003
- lower Limit
- 5
- upper Limit
- 28.6
- value
- 16.80
- group Id
- OG004
- lower Limit
- 1.7
- upper Limit
- 71.3
- value
- 13.50
- group Id
- OG005
- lower Limit
- 1
- upper Limit
- 47
- value
- 3.40
- title
- Day 1 (Postdose)
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 5
- units
- Participants
- description
- Bound samalizumab was detected using a monoclonal antibody (mAb) specific for samalizumab. The binding of samalizumab to CD200 on peripheral B-CLL tumor cells was evaluated in participants with B-CLL by flow cytometry and expressed as the percent of B-CLL cells bound by samalizumab. For participants with insufficient numbers of peripheral B-CLL for analysis, the samples were documented as "unevaluable" and an analysis was not performed.
- dispersion Type
- Full Range
- groups
- description
- Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG000
- title
- Samalizumab 50 mg/m^2
- description
- Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG001
- title
- Samalizumab 100 mg/m^2
- description
- Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG002
- title
- Samalizumab 200 mg/m^2
- description
- Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG003
- title
- Samalizumab 300 mg/m^2
- description
- Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG004
- title
- Samalizumab 400 mg/m^2
- description
- Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG005
- title
- Samalizumab 500 mg/m^2
- param Type
- MEDIAN
- population Description
- All participants with B-CLL who had evaluable assessments for bound samalizumab were included in the analysis. No participants with B-CLL received samalizumab at the 600 mg/m\^2 dose level.
- reporting Status
- POSTED
- time Frame
- Baseline (Predose) and Day 1 (Postdose)
- title
- Percent Of Bound Samalizumab On B-Cell Chronic Lymphocytic Leukemia (B-CLL) Cells In Participants With B-CLL At Baseline (Predose) And Day 1 (Postdose)
- type
- SECONDARY
- unit Of Measure
- percentage of B-CLL cells bound
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Preserved source evidence · Not medical advice