TriangleNCT00648739 · OUTCOME
Density Of B-CLL Cells Bound 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
- mean channel fluorescent intensity
- Interval / dispersion
- Full Range
- Time frame
- Baseline (Predose) and Day 1 (Postdose)
What was measured
Bound samalizumab was detected using a 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 mean channel fluorescence intensity (MFI) of bound samalizumab to provide an indication of the density of bound samalizumab on target B-CLL cells. 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 | 2.95 | Not reported | 1.9 | 11 | Not reported |
| Samalizumab 100 mg/m^2 | 4.10 | Not reported | 3.5 | 5.6 | Not reported |
| Samalizumab 200 mg/m^2 | 3.25 | Not reported | 3.2 | 3.3 | Not reported |
| Samalizumab 300 mg/m^2 | 2.35 | Not reported | 1.7 | 3 | Not reported |
| Samalizumab 400 mg/m^2 | 2.40 | Not reported | 1.7 | 3.4 | Not reported |
| Samalizumab 500 mg/m^2 | 1.40 | Not reported | 1 | 3.7 | Not reported |
Day 1 (Postdose)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Samalizumab 50 mg/m^2 | 3.85 | Not reported | 3.3 | 4.1 | Not reported |
| Samalizumab 100 mg/m^2 | 7.10 | Not reported | 5 | 11.1 | Not reported |
| Samalizumab 200 mg/m^2 | 17.95 | Not reported | 16.6 | 19.3 | Not reported |
| Samalizumab 300 mg/m^2 | 11.20 | Not reported | 5.6 | 16.8 | Not reported |
| Samalizumab 400 mg/m^2 | 5.80 | Not reported | 4.6 | 26.6 | Not reported |
| Samalizumab 500 mg/m^2 | 2.30 | Not reported | 1.9 | 17.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- 11
- value
- 2.95
- group Id
- OG001
- lower Limit
- 3.5
- upper Limit
- 5.6
- value
- 4.10
- group Id
- OG002
- lower Limit
- 3.2
- upper Limit
- 3.3
- value
- 3.25
- group Id
- OG003
- lower Limit
- 1.7
- upper Limit
- 3
- value
- 2.35
- group Id
- OG004
- lower Limit
- 1.7
- upper Limit
- 3.4
- value
- 2.40
- group Id
- OG005
- lower Limit
- 1
- upper Limit
- 3.7
- value
- 1.40
- title
- Baseline (Predose)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.3
- upper Limit
- 4.1
- value
- 3.85
- group Id
- OG001
- lower Limit
- 5
- upper Limit
- 11.1
- value
- 7.10
- group Id
- OG002
- lower Limit
- 16.6
- upper Limit
- 19.3
- value
- 17.95
- group Id
- OG003
- lower Limit
- 5.6
- upper Limit
- 16.8
- value
- 11.20
- group Id
- OG004
- lower Limit
- 4.6
- upper Limit
- 26.6
- value
- 5.80
- group Id
- OG005
- lower Limit
- 1.9
- upper Limit
- 17.6
- value
- 2.30
- 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 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 mean channel fluorescence intensity (MFI) of bound samalizumab to provide an indication of the density of bound samalizumab on target B-CLL cells. 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
- Density Of B-CLL Cells Bound At Baseline (Predose) And Day 1 (Postdose)
- type
- SECONDARY
- unit Of Measure
- mean channel fluorescent intensity
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice